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Journal articles on the topic 'Westgard Rules'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Putri, Oktavia Amanda, Woro Umi Ratih, and Monika Putri Solikah. "Quality Control Inspection Results Platelets and Leukocytes Based on the Westgard Rule and Six Sigma at Rs Pku Muhammadiyah Bantul." Journal of Social Science 5, no. 4 (2024): 1159–67. http://dx.doi.org/10.46799/jss.v5i4.882.

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Internal Quality Consolidation (PMI) is a preventive and monitoring activity carried out by each laboratory continuously so that errors or deviations do not occur so that correct inspection results are obtained, one of which is carrying out quality control (QC) using the Westgard Rule and Six Sigma . The Westgard rule is used to see whether there are analytical errors that occur with the 12 S , 13 S , 22 S , R4 S , 41 S , 10 X series of rules . Six sigma is used to assess the quality of a laboratory's performance by looking at the minimum sigma value level with a value of 3σ and a maximum of ≥

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Bayat, Hassan, and Sten Westgard. "Reply to Christelli et al.: Implementation of new Westgard Rules suggested by the Westgard Advisor software for five immunological parameters. What Six Sigma, quality control, the analytical Sigma-metric, and Westgard Advisor can and cannot do." Biochemia medica 35, no. 2 (2025): 169–71. https://doi.org/10.11613/bm.2025.020401.

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The study of Cristelli et al. attempted to find fault with the rules suggested by Westgard Advisor software, claiming that implementing those rules did not improve the method performance. A fundamental misunderstanding of the utility and purpose of the analytical Sigma-metric and QC rules needs to be clarified.

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Bishop, J., and A. B. Nix. "Comparison of quality-control rules used in clinical chemistry laboratories." Clinical Chemistry 39, no. 8 (1993): 1638–49. http://dx.doi.org/10.1093/clinchem/39.8.1638.

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Abstract Numerous papers have been written to show which combinations of Shewhart-type quality-control charts are optimal for detecting systematic shifts in the mean response of a process, increases in the random error of a process, and linear drift effects in the mean response across the assay batch. One paper by Westgard et al. (Clin Chem 1977;23:1857-67) especially seems to have attracted the attention of users. Here we derive detailed results that enable the characteristics of the various Shewhart-type control schemes, including the multirule scheme (Clin Chem 1981;27:493-501), to be calcu

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Rahmani, Afina Rusyda, Arifiani Agustin Amalia, and Dhiah Novalina. "Analisis Quality Control (QC) Pemeriksaan Albumin Dan Bilirubin Menggunakan Kontrol Harian Dan Matriks Sigma." Borneo Journal of Medical Laboratory Technology 7, no. 1 (2024): 481–89. https://doi.org/10.33084/bjmlt.v7i1.7863.

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Quality control (QC) merupakan suatu proses evaluasi pengujian mutu laboratorium yang bertujuan untuk menjamin sistem mutu laboratorium. Six sigma merupakan indikator kualitas yang digunakan untuk mengevaluasi kinerja analitik. Penelitian ini bertujuan untuk mengetahui nilai data kontrol harian melalui evaluasi grafik Levey-jennings dan mengetahui nilai sigma beserta DPMO pada pemeriksaan albumin dan bilirubin total. Metode penelitian yang digunakan yaitu metode deskriptif kuantitatif dengan pendekatan penelitian cross sectional. Metode pengambilan sampel pada penelitian ini menggunakan Teknik

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Levine, Jacob B. "How the Westgard QC Rules Got Their Name: A Personal Recollection." Clinical Chemistry 64, no. 5 (2018): 874–76. http://dx.doi.org/10.1373/clinchem.2018.288696.

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Dau, Daniel, Ferdy Royland Marpaung, and Puspa Wardhani. "Internal quality analysis of hematology examination using Westgard rules and six sigma, quality goal index, and root cause analysis at the remote clinical laboratory." Bali Medical Journal 13, no. 3 (2024): 1434–39. https://doi.org/10.15562/bmj.v13i3.5430.

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Introduction: The complete blood count (CBC) results are very important in clinical diagnosis decisions for patients. Imprecision and inaccuracy may lead to errors in patient diagnosis and treatment. To ensure a valid result, it is critical to evaluate the laboratory quality control (QC). However, QC evaluation in very remote areas remains scarce. This study aims to analyze the presentation of blood count quality control in a remote laboratory. Methods: The study collected 90 samples of quality control measurements in August 2023. The research data were analyzed using Westgard guidelines, Six

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Linnet, Kristian. "EZ rules: Automatic Selection of Statistical Control Rules for Laboratory Tests. Westgard QC, Inc. Madison, WI: Westgard QC, Inc., 2000, 154 pp., $295.00. ISBN 1-886958-14-9." Clinical Chemistry 48, no. 3 (2002): 594–95. http://dx.doi.org/10.1093/clinchem/48.3.594.

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Prasetya, Hieronymus Rayi, Nurlaili Farida Muhajir, and Magdalena Putri Iriyanti Dumatubun. "PENGGUNAAN SIX SIGMA PADA PEMERIKSAAN JUMLAH LEUKOSIT DI RSUD PANEMBAHAN SENOPATI BANTUL." Journal of Indonesian Medical Laboratory and Science (JoIMedLabS) 2, no. 2 (2021): 165–74. http://dx.doi.org/10.53699/joimedlabs.v2i2.72.

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Internal quality assurance is a prevention and control activity that must be carried out by the laboratory continuously and covers all aspects of laboratory examination parameters. Hematology examination in the laboratory is carried out using a Hematology analyzer, but this tool has limitations, one of which is that it can make leukocyte count reading errors. In order for the results of the tool to be reliable, it is necessary to carry out quality control on the hematology analyzer. The use of Westgard multirule is commonly used in laboratories, but the application of six sigma is still very r

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Bietenbeck, Andreas, Markus A. Thaler, Peter B. Luppa, and Frank Klawonn. "Stronger Together: Aggregated Z-values of Traditional Quality Control Measurements and Patient Medians Improve Detection of Biases." Clinical Chemistry 63, no. 8 (2017): 1377–87. http://dx.doi.org/10.1373/clinchem.2016.269845.

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Abstract BACKGROUND In clinical chemistry, quality control (QC) often relies on measurements of control samples, but limitations, such as a lack of commutability, compromise the ability of such measurements to detect out-of-control situations. Medians of patient results have also been used for QC purposes, but it may be difficult to distinguish changes observed in the patient population from analytical errors. This study aims to combine traditional control measurements and patient medians for facilitating detection of biases. METHODS The software package “rSimLab” was developed to simulate mea

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Blum, A. S. "Computer evaluation of statistical procedures, and a new quality-control statistical procedure." Clinical Chemistry 31, no. 2 (1985): 206–12. http://dx.doi.org/10.1093/clinchem/31.2.206.

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Abstract I describe a program for definitive comparison of different quality-control statistical procedures. A microcomputer simulates quality-control results generated by repetitive analytical runs. It applies various statistical rules to each result, tabulating rule breaks to evaluate rules as routinely applied by the analyst. The process repeats with increasing amounts of random and systematic error. Rate of false rejection and true error detection for currently popular statistical procedures were comparatively evaluated together with a new multirule procedure described here. The nature of

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Westgard, James O., and Sten A. Westgard. "Establishing Evidence-Based Statistical Quality Control Practices." American Journal of Clinical Pathology 151, no. 4 (2018): 364–70. http://dx.doi.org/10.1093/ajcp/aqy158.

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AbstractObjectivesTo establish an objective, scientific, evidence-based process for planning statistical quality control (SQC) procedures based on quality required for a test, precision and bias observed for a measurement procedure, probabilities of error detection and false rejection for different control rules and numbers of control measurements, and frequency of QC events (or run size) to minimize patient risk.MethodsA Sigma-Metric Run Size Nomogram and Power Function Graphs have been used to guide the selection of control rules, numbers of control measurements, and frequency of QC events (

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Kiatsiri, K. "Evaluation of glucose testing performance in clinicallaboratory by single-rule and Westgard multi-rules." Chulalongkorn Medical Journal 53, no. 2 (2009): 91–106. http://dx.doi.org/10.58837/chula.cmj.53.2.3.

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Pradella, Marco. "Internal Quality Control in Medical Laboratories: Westgard and the Others." Laboratories 2, no. 3 (2025): 15. https://doi.org/10.3390/laboratories2030015.

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This review recalls some ISO 15189:2022 requirements for the management of examination results and emerging alternatives to internal quality control (IQC) in relation to Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) Recommendation Q19. We observed phenomena of contrasting “metrological”, or rather “tracealogic”, and “statistical” approaches. SIPMeL Recommendation Q19 enhances IQC with a moving average based on ISO 15189, which enables the use of the moving average of patient sample results (MA). In the veterinary field, the procedure of QC with repeat testing on patien

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Dy, P. R., K. B. Damian, and E. Q. Villanueva. "Evaluation of the Hematology Analyzer Test Performance Using Six Sigma Metrics: A Cross Sectional Study." American Journal of Clinical Pathology 162, Supplement_1 (2024): S73. http://dx.doi.org/10.1093/ajcp/aqae129.162.

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Abstract Introduction/Objective The six sigma metric is used to assess the performance of a measurement procedure in comparison to the medical requirement. In clinical laboratories, it can be used to assess the quality of instruments or processes. This study aims to evaluate the performance of hematology analyzers using the six sigma scale. Methods/Case Report This is a descriptive cross-sectional study wherein quality control data from hematology analyzers were obtained. The mean, standard deviation, coefficient of variation, bias and sigma value of the RBC, WBC, hemoglobin, hematocrit, and p

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Kumar, B. Vinodh, and Thuthi Mohan. "Sigma metrics as a tool for evaluating the performance of internal quality control in a clinical chemistry laboratory." Journal of Laboratory Physicians 10, no. 02 (2018): 194–99. http://dx.doi.org/10.4103/jlp.jlp_102_17.

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Abstract OBJECTIVE: Six Sigma is one of the most popular quality management system tools employed for process improvement. The Six Sigma methods are usually applied when the outcome of the process can be measured. This study was done to assess the performance of individual biochemical parameters on a Sigma Scale by calculating the sigma metrics for individual parameters and to follow the Westgard guidelines for appropriate Westgard rules and levels of internal quality control (IQC) that needs to be processed to improve target analyte performance based on the sigma metrics. MATERIALS AND METHOD

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Permata Sari, Cecilia Febiyono, Fitriani Kahar, Irnawati Irnawati, Muhammad Yusuf, Abdul Salam, and Abdul Wadood. "Perbandingan Hasil Pemeriksaan Protein Urine Metode Carik Celup, Asam Asetat 6%, dan Asam Sulfosalisilat 20% Menggunakan Aturan Westgard." Jaringan Laboratorium Medis 5, no. 2 (2023): 84–94. http://dx.doi.org/10.31983/jlm.v5i2.9784.

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Proteinuria is caused by kidney damage. Qualitative examination of urine protein can be carried out using the dip strip method, 6% acetic acid and 20% sulfosalicylic acid. The aim of this research is to determine the accuracy and precision of urine protein examination using the dip strip method, 6% acetic acid and 20% sulfosalicylic acid. The research was experimental with repeated measurements of levels carried out visually and gave positive results of 1, 2, 3 and 4. The research was carried out in January 2022 using a research sample of 20 proteinuria positive patients at RSJD Dr. Amino Gond

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Gruber, Lorenz, Artur Hausch, and Thomas Mueller. "Internal Quality Controls in the Medical Laboratory: A Narrative Review of the Basic Principles of an Appropriate Quality Control Plan." Diagnostics 14, no. 19 (2024): 2223. http://dx.doi.org/10.3390/diagnostics14192223.

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To ensure the quality of their analyses, medical laboratories carry out internal quality control (IQC) on a daily basis. IQC involves control samples with known target values for all parameters used by a laboratory in clinical practice. The use of IQC enables the laboratory to monitor the accuracy and precision of laboratory results. The use of appropriate IQC strategies has been accepted in medical laboratories for decades, and IQC has been included in international recommendations and guidelines. The term “IQC strategy” (also termed a quality control plan) refers to the types of IQC material

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Lasky, Fred D. "CLIA Final Rules for Quality Systems: Quality Assessment Issues and Answers. James O. Westgard, Sharon S. Ehrmeyer, and Teresa P. Darcy. Madison, WI: Westgard QC, Inc., 2004, 225 pp., softcover, $60.00 ($50.00 AACC members). ISBN 1-886958-20-3." Clinical Chemistry 51, no. 10 (2005): 1911–12. http://dx.doi.org/10.1373/clinchem.2005.047910.

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Kilpatrick, Eric S. "Quality control failures exceeding the weekly limit (QC FEWL): a simple tool to improve assay error detection." Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 56, no. 6 (2019): 668–73. http://dx.doi.org/10.1177/0004563219869043.

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Background Even when a laboratory analyte testing process is in control, routine quality control testing will fail with a frequency that can be predicted by the number of quality control levels used, the run frequency and the control rule employed. We explored whether simply counting the number of assay quality control run failures during a running week, and then objectively determining if there was an excess, could complement daily quality control processes in identifying an out-of-control assay. Methods Binomial statistics were used to determine the threshold number of quality control run fa

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Siddiqui, I., A. Habib Khan, S. Imran, and L. Jafri. "M068 An audit on the awareness of Westgard rules as quality control monitoring tool among medical laboratory technologists of a tertiary care hospital." Clinica Chimica Acta 530 (May 2022): S113—S114. http://dx.doi.org/10.1016/j.cca.2022.04.601.

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Yudita, Ferina, Dwi Purbayanti, Fitria Hariati Ramdhani, and Eka Jaya. "Evaluasi Kontrol Kualitas Pemeriksaan Glukosa Darah di Laboratorium X Palangka Raya." Borneo Journal of Medical Laboratory Technology 5, no. 2 (2023): 358–65. http://dx.doi.org/10.33084/bjmlt.v5i2.5184.

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Quality Control is a managerial procedure to adjust the laboratory examination (analytic) stages and detect errors early. The purpose of this study was to describe the quality control in laboratory X in the city of Palangka Raya. The method used is the descriptive method. The results showed that in April 2022, the Mean (88,1 mg/dL), SD (1,09 mg/dL), CV (1,24%), d (0,14%), TE (2,62%), TEa (10%), Sigma (7,94), and in May 2022 the Mean (87,9 mg/dL), SD (1,00 mg/dL), CV (1,13%), d (0,04%), TE (2,31%), TEa (10%), Sigma (8,79). According to the Ministry of Health, the maximum CV value is < 5%, so

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Khatri, Roshan, Sanjay KC, Prabodh Shrestha, and J. N. Sinha. "Implementing Self Sustained Quality Control Procedures in a Clinical Laboratory." Journal of Nepal Medical Association 52, no. 189 (2013): 233–37. http://dx.doi.org/10.31729/jnma.560.

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Introduction: Quality control is an essential component in every clinical laboratory which maintains the excellence of laboratory standards, supplementing to proper disease diagnosis, patient care and resulting in overall strengthening of health care system. Numerous quality control schemes are available, with combinations of procedures, most of which are tedious, time consuming and can be “too technical” whereas commercially available quality control materials can be expensive especially for laboratories in developing nations like Nepal. Here, we present a procedure performed at our centre wi

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Nabil, Ayman Mohamed, Hayat Mirza Alsaif, Muneer Ahmad Aljamaan, et al. "Impact of using cross-over CV and mean for two different lots of assay control on implementation of Westgard rules in chemical diagnostic tests." Practical Laboratory Medicine 44 (April 2025): e00449. https://doi.org/10.1016/j.plabm.2025.e00449.

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Bogaert, Laura, Stefanie Van den Bremt, Sofie Schouwers, Xavier Bossuyt, and Lieve Van Hoovels. "Harmonizing by reducing inter-run variability: performance evaluation of a quality assurance program for antinuclear antibody detection by indirect immunofluorescence." Clinical Chemistry and Laboratory Medicine (CCLM) 57, no. 7 (2019): 990–98. http://dx.doi.org/10.1515/cclm-2018-0933.

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Abstract Background The introduction of automated anti-nuclear antibody (ANA) indirect immunofluorescence (IIF) analysis may allow for more harmonized ANA IIF reporting, provided that a thorough quality assurance program controls this process. The aim of this study was to evaluate various quality indicators used for ANA IIF analysis with the final goal of optimizing the iQC program. Methods In an experimental setup, we introduced artificial errors, mimicking plausible problems during routine practice on a QUANTA-Lyser-NOVA View® system (Inova Diagnostics, San Diego, CA, USA). Predetermined qua

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Kristinawati, Erna, Miftahul Jannah, and Yudha Anggit Jiwantoro. "Test Results Of Quality Control Examination Of Erythrocytes (RBC), Hemoglobin (HB) And Thrombocytes (PLT) Using The Six Sigma Method At UPTD RSUD." Jurnal Analis Medika Biosains (JAMBS) 12, no. 1 (2025): 52. https://doi.org/10.32807/jambs.v12i1.439.

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Hospital quality must be improved to maintain the quality of service to patients. One of the laboratory tests is hematology examination. Hematology examination has used Automatic Hematology Analyzer. To ensure the accuracy, precision and accuracy of laboratory examinations, Quality Control is needed. Six Sigma is a metric that measures process performance as the level of Defects Per Million Opportunities (DPMO), DPMO is one of the Process Capability assessments to measure how good a production process is on a scale of 1-6. To determine the quality of tools using the Six Sigma method. The resea

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Van Hoovels, Lieve, Xavier Bossuyt, Mariangela Manfredi, et al. "Integrating quality assurance in autoimmunity: the changing face of the automated ANA IIF test." Clinical Chemistry and Laboratory Medicine (CCLM) 59, no. 7 (2021): 1247–55. http://dx.doi.org/10.1515/cclm-2020-1669.

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Abstract Objectives Currently available computer-aided diagnosis (CAD) systems for the detection of anti-nuclear antibodies (ANA) by indirect immunofluorescence (IIF) assay enable a standardized measurement of system-specific fluorescent intensity (FI) measures. We aimed to evaluate an internal quality control (iQC) program that controls the total ANA IIF process in routine practice. Methods In addition to the kit iQC materials, supplemental quality indicators were integrated in a total quality assurance (QA) program: patient-derived iQC’s samples (negative, 1/160 fine speckled and 1/160 homog

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Mbasani, Rogious, Luo Xigang, and Nelson Musilanga. "Evaluation of clinical biochemical laboratory analytical process performance using sigma metrics and quality goal index." Chinese Journal of Medical Research 4, no. 4 (2021): 71–78. http://dx.doi.org/10.37515/cjmr.091x.4403.

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Background: Application of sigma matrics across clinical laboratory diagnostic process enables identification of errors in methods together with quality goal index can help point out the cause of unacceptable process performance. We believe the analytical performance of the clinical biochemistry laboratory standards do not meet the required quality according to six sigma standards. Aim and Objective: The study aimed at performance evaluation of clinical biochemical laboratory analytical process using sigma metrics and quality goal index. Methods: Sigma (σ) for the 20 analytes performed on HITA

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Dimech, Wayne, Marina Karakaltsas, and Giuseppe A. Vincini. "Comparison of four methods of establishing control limits for monitoring quality controls in infectious disease serology testing." Clinical Chemistry and Laboratory Medicine (CCLM) 56, no. 11 (2018): 1970–78. http://dx.doi.org/10.1515/cclm-2018-0351.

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Abstract Background: A general trend towards conducting infectious disease serology testing in centralized laboratories means that quality control (QC) principles used for clinical chemistry testing are applied to infectious disease testing. However, no systematic assessment of methods used to establish QC limits has been applied to infectious disease serology testing. Methods: A total of 103 QC data sets, obtained from six different infectious disease serology analytes, were parsed through standard methods for establishing statistical control limits, including guidelines from Public Health En

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Bhatnagar, Sonu, Sten Westgard, Nguyen Thi Thanh Dung, Tran Ngoc Que, Bach Quoc Khanh, and Nguyen Ha Thanh. "Applying sigma metrics to assess quality control processes in the transfusion transmissible infection screening laboratory of a blood center." PLOS ONE 19, no. 10 (2024): e0312422. http://dx.doi.org/10.1371/journal.pone.0312422.

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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 s

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Niry Manantsoa, S., J. Andriamampihonona, F. H. Rakotonjafiniarivo, et al. "QUALITY CONTROL MANAGEMENT ISSUES OF ROUTINE COAGULATION TEST IN A LOW-INCOME COUNTRY (MADAGASCAR)." International Journal of Advanced Research 11, no. 01 (2023): 1017–22. http://dx.doi.org/10.21474/ijar01/16113.

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Introduction: Reliability of biological assays results depends closely on the quality of the 3 biological stages: pre-analytical, analytical, and post-analytical. In each stage, a quality program including internal quality control (IQC) and external quality assurance (EQA) has to be assessed to ensure test result accuracy and precision. The coagulation laboratory plays an important role in the diagnosis and treatment of people with blood disorders, so though several lack of facilities in Malagasy labs, QC has to be implemented. Thus, this study aimed to analyze IQC and EQA in hemostasis tests

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Asinas, J. M. "Applying The Best Practice For Internal Quality Control (IQC) Management, Consolidation And Review Process In Sidra Medicine Clinical Chemistry Division." American Journal of Clinical Pathology 154, Supplement_1 (2020): S91. http://dx.doi.org/10.1093/ajcp/aqaa161.199.

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Abstract Introduction/Objective The management of internal quality control (IQC) in Sidra Medicine Clinical Chemistry Division has been evaluated in order to promote a more consolidated and efficient process of IQC management. The statistical data produced from Cerner QC Module are transferred to IQC review templates consisting of formulas to auto- calculate parameters such as multiple of expected QC failure frequency and desirable comparison limit between analyzers. The IQC review and documentation process using the in-house excel template requires several hours to complete, hence a faster an

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MT Gusti, Amani, Malik S. Almuqati, Saleh A. Alkhilafi, et al. "IMPROVING QUALITY AND EFFICIENCY PERFORMANCE OF ANALYTICAL TESTING PROCESS USING SIGMA METRICS IN EMERGENCY LABORATORY OF KING FAHD ARMED FORCES HOSPITAL, JEDDAH, SAUDI ARABIA." International Journal of Advanced Research 11, no. 11 (2023): 583–606. http://dx.doi.org/10.21474/ijar01/17860.

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Background: Six Sigma is a popular quality management system tool used for process improvement. Using that, the clinical technologist can directly intervene to improve the quality of test reporting during the analytical phase of the total testing process in the medical laboratory. The present study aimed to assess and continuously improve the performance of individual biochemical and hematological parameters on a Sigma Scale by calculating the Sigma metrics for individual parameters redesigning and customizing the internal quality control (IQC). A sigma metric is a simple measurement of assay

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Preston, Nina. "‘Enabling Environments’: The lived experience of Category A prisoners on a Dangerous and Severe Personality Disorder unit." Forensic Update 1, no. 108 (2012): 32–38. http://dx.doi.org/10.53841/bpsfu.2012.1.108.32.

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The study explores the lived experience of Category A prisoners on a Dangerous and Severe Personality Disorder (DSPD) unit. Specifically the focus was on exploring what core environmental qualities Category A prisoners residing on a DSPD unit consider to be necessary for the unit to be an ‘enabling environment’ based on their actual experience of engaging and residing on the Westgate DSPD unit. A secondary aim of exploring the congruence between participants’ responses and the nine core elements of an ‘enabling environment’ proposed by Johnson and Haigh (2011) was also considered. An Interpret

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Bouacha, Nadjet, and Mouloud Belachia. "Elaboration of an Expert System for Sizing, Designing and Verifying Flexible Pavements." Civil and Environmental Engineering Reports 30, no. 3 (2020): 94–121. http://dx.doi.org/10.2478/ceer-2020-0035.

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Abstract The use of expert systems in the world of civil engineering, and in particular for roads, has become a necessity for the reason of the particularity, complexity, and diversity of the influencing parameters at the level of the design calculation, the latter of which represents the major source of subsequent degradation. This system consists of proposing a tool for helping the user firstly to size the body of the roadway, with several analytical methods and models (Pre-project, Boussinesq, Westgaard, and Burmister), and secondly, to offer different design possibilities (thickness and ty

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Gomes, Gabriel Thé Araújo. "Quality Control in RT-PCR Viral Load Assays: Evaluation of Analytical Performance for HIV, HBV, and HCV." Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine 35, no. 2 (2024): 91–99. https://doi.org/10.5281/zenodo.15538167.

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IntroductionQuality Control Management (QCM) in clinical laboratoriesis crucial for ensuring reliable results in analyticalmeasurements, with biological variation being a key factor.The study focuses on assessing the analytical performance ofthe Reverse Transcription Polymerase Chain Reaction (RTPCR)system for Human Immunodeficiency Virus (HIV),Hepatitis B (HBV), and Hepatitis C (HCV). Five modelsproposed between 1999 and 2014 offer different approachesto evaluating analytical quality, with Model 2 based onbiological variation and Model 5 considering the currentstate of the art. The study eval

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Song, Zhenzhen, Jiajia Zhang, Bing Liu, Hao Wang, Lijun Bi, and Qingxia Xu. "Practical application of European biological variation combined with Westgard Sigma Rules in internal quality control." Clinical Chemistry and Laboratory Medicine (CCLM), August 29, 2022. http://dx.doi.org/10.1515/cclm-2022-0327.

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Abstract Objectives Westgard Sigma Rules is a statistical tool available for quality control. Biological variation (BV) can be used to set analytical performance specifications (APS). The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) regularly updates BV data. However, few studies have used robust BV data to determine quality goals and design a quality control strategy for tumor markers. The aim of this study was to derive APS for tumor markers from EFLM BV data and apply Westgard Sigma Rules to establish internal quality control (IQC) rules. Methods Precision was ca

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Brooks, Z. C. "B-156 Impact of Seven Incremental Scenarios of QC Strategies." Clinical Chemistry 69, Supplement_1 (2023). http://dx.doi.org/10.1093/clinchem/hvad097.489.

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Abstract Background CLSI EP23A states that “At the least, the ability of the QC procedures to detect medically allowable error should be evaluated.” It also defines that “The QC strategy using QC samples should include the following for each measuring system: Methods Eighty QC sample mean and SD values were compared to Peer Means and TEa limits for 14 routine chemistry analytes and four cardiac markers tested in December 2022. The number of patient results was normalized to 200 and 60 per day for routine and cardiac; the number reported before the first QC flag after a simulated shift to a 5%

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Cristelli, Lisa, Francesca Occhipinti, Daniel Tumiatti, De Luisi Antonia, Erika Jani, and Massimo Daves. "Implementation of new Westgard rules suggested by the Westgard Advisor software for five immunological parameters." Biochemia Medica 35, no. 1 (2025). https://doi.org/10.11613/bm.2025.010701.

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Li, Houli, Di Zhang, Xiaoliang Cheng, et al. "Application of the Westgard Multi-Rule Theory to Internal Quality Control Evaluation of Voriconazole for Therapeutic Drug Monitoring." Current Pharmaceutical Analysis 16 (August 18, 2020). http://dx.doi.org/10.2174/1573412916999200818104337.

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Background: There is no worldwide recognized reference internal quality control method for therapeutic drug monitoring (TDM) of voriconazole (VCZ) by liquid chromatography (LC). In this study, we aimed to develop an internal quality control method for TDM of VCZ, evaluate it by the Westgard Multi-rule Theory, and guarantee the analytical quality of the assays. Method: The plasma concentration of VCZ was detected by two-dimensional liquid chromatography with ultraviolet detection (2D-LC-UV) method. The internal quality control results accompanying with TDM of VCZ in our laboratory from July 201

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Poh, Daren Kiat How, Chun Yee Lim, Rui Zhen Tan, Corey Markus, and Tze Ping Loh. "Internal quality control: moving average algorithms outperform Westgard rules." Clinical Biochemistry, September 2021. http://dx.doi.org/10.1016/j.clinbiochem.2021.09.007.

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Schmidt, Robert L., Ryleigh A. Moore, Brandon S. Walker, and Joseph W. Rudolf. "Precision quality control: a dynamic model for risk-based analysis of analytical quality." Clinical Chemistry and Laboratory Medicine (CCLM), January 9, 2023. http://dx.doi.org/10.1515/cclm-2022-1094.

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Abstract Objectives There is continuing pressure to improve the cost effectiveness of quality control (QC) for clinical laboratory testing. Risk-based approaches are promising but recent research has uncovered problems in some common methods. There is a need for improvements in risk-based methods for quality control. Methods We provide an overview of a dynamic model for assay behavior. We demonstrate the practical application of the model using simulation and compare the performance of simple Shewhart QC monitoring against Westgard rules. We also demonstrate the utility of trade-off curves for

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Rohit, S., and R. Ramesh. "Effect of Internal Quality Planning using Sigma Metrics in Lean Management of a Clinical Chemistry Laboratory: An Analytical Study." JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH, 2024. http://dx.doi.org/10.7860/jcdr/2024/67309.19260.

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Introduction: Across the globe, quality control systems serve as the foundation for providing accurate and precise results, and also immediate error detection. However, many laboratories adhere to uniform Quality Control (QC) rules for all parameters, which may result in unnecessary overspending. The present study aimed to establish individual control rules and determine the number of control measurements for each of the 10 parameters using Westgard Entgegen-Zusammen (EZ) Rules 3 software. The cost-effectiveness and benefits of applying these new rules were evaluated, alongside the lot-to-date

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Westgard, S. "A-003 Beckman Coulter DxI 9000 Immunoassay Analyzer’s High Sensitivity Troponin I achieves >90% six sigma performance when assessed against clia 2024 performance goals." Clinical Chemistry 70, Supplement_1 (2024). http://dx.doi.org/10.1093/clinchem/hvae106.003.

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Abstract Background In July 2024, the Clinical Laboratory Improvement Act (CLIA) proficiency testing (PT) criteria will directly regulate Troponin I performance for the very first time. The new CLIA goal is 0.9 ng/mL or 30%, whichever is greater. CAP previously set a goal of 30% or 3 times the group standard deviation (SD), whichever is greater, a more permissive setting. Estimates of current instrument group performance from an international proficiency testing (PT) survey have shown none of the 5 major diagnostic instruments can achieve the biological minimum goal at a 6-Sigma level, while 4

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Pradhan, Devi Prasad, Debasish Pandit, Sibasish Sahoo, Roma Rattan, and Sucharita Mohanty. "Six Sigma Metrics: An Evolving Indicator of Quality Assurance for Clinical Biochemistry." JOURNAL OF CLINICAL AND DIAGNOSTIC RESEARCH, 2022. http://dx.doi.org/10.7860/jcdr/2022/56691.16718.

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Introduction: The analytical phase of the total testing process is the one in which the clinical biochemist can directly intervene to improve the quality of tests reporting. The sigma metrics and Operational Process Specification (OPSpec) chart can specify to which category the laboratory belongs. Aim: To apply sigma metrics to analytical process of testing, do the root cause analysis and apply the corrective measures according to Westgard Rules to improve laboratory performance towards the quality assurances. Materials and Methods: This was a retrospective-prospective study carried out in a c

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Newton, Duane W., Nico Vandepoele, John C. Yundt-Pacheco, David Gauthier, and Michael A. Bachman. "Management of Cytomegalovirus, Epstein-Barr Virus, and HIV Viral Load Quality Control Data Using Unity Real Time." Journal of Clinical Microbiology 60, no. 1 (2022). http://dx.doi.org/10.1128/jcm.01675-21.

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Quality control (QC) rules (Westgard rules) are applied to viral load testing to identify runs that should be reviewed or repeated, but this requires balancing the patient safety benefits of error detection with the cost and inefficiency of false rejection. In this study, we identified the total allowable errors (TEa) from the literature and utilized a commercially available software program (Unity Real Time; Bio-Rad Laboratories) to manage QC data, assess assay performance, and provide QC decision support for both FDA-approved/cleared (Abbott cytomegalovirus [CMV] and HIV viral load) as well

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Wang, Yuanfang, Xiaohan Li, Dongdong Li, and Yi Xie. "A modified quality control protocol for infectious disease serology based on the Westgard rules." Scientific Reports 14, no. 1 (2024). http://dx.doi.org/10.1038/s41598-024-67472-1.

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AbstractWhen traditional statistical quality control protocols, represented by the Westgard protocol were applied to infectious disease serology, the rejection limits were questioned because of the high rejection probability. We first define the probability of false rejection (Pfr) and error detection (Ped) for infectious disease serology. QC data in 6 months were collected and the Pfr of each rule in the Westgard protocol and Rilibak protocol was evaluated. Then, as improvements, we chose different rules for negative and positive QC data to constitute an asymmetric protocol, furthermore, whil

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Westgard, S. "B-113 Beckman Coulter DxI 9000 immunoassay analyzer assay performance meets new CLIA 2024 performance goals with highest proportion of Six Sigma performance amongst all major manufacturers." Clinical Chemistry 70, Supplement_1 (2024). http://dx.doi.org/10.1093/clinchem/hvae106.474.

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Abstract Background The Clinical Laboratory Improvement Act (CLIA) proficiency testing (PT) criteria will be updated in July 2024 with some goals tightening by up to 40%. It is assumed, but not known, that all assays and instruments will be able to achieve these goals. Using these new CLIA 2024 goals, estimates of current instrument group performance from an international proficiency testing (PT) survey have shown significant differences in quality, calling into question which assays can achieve the new CLIA goals. Currently, the highest performing diagnostic instrument achieves only 35.2% 6-S

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Zhao, Furong, Guoliang Pan, Mo Hong, et al. "Evaluation of analytical performance of homocysteine LC-MS/MS assay and design of internal quality control strategy." Clinical Chemistry and Laboratory Medicine (CCLM), January 13, 2023. http://dx.doi.org/10.1515/cclm-2022-0805.

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Abstract Objectives Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has become a common technique in clinical laboratories in recent years. Because most methods are laboratory-developed tests (LDTs), their reproducibility and quality control (QC) have been controversial. In this study, Westgard Sigma Rules were used to evaluate the analytical performance and establish an individualised internal QC (IQC) strategy for these LDTs. Methods Taking the LC-MS/MS LDT method for homocysteine (Hcy) as an example, the ‘desirable specifications’ from the Biological Variation Database were used a

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Dimech, Wayne, Giuseppe Vincini, and Marina Karakaltsas. "Determination of quality control limits for serological infectious disease testing using historical data." Clinical Chemistry and Laboratory Medicine (CCLM) 53, no. 2 (2015). http://dx.doi.org/10.1515/cclm-2014-0546.

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AbstractAn effective quality control (QC) program requires the establishment of control limits within which the results of the QC sample is expected to fall. Traditionally, the mean plus/minus two standard deviations calculated for a set of QC sample results is used to establish control limits. Allowable total error (TEa) and Westgard rules aid in interpreting QC sample results. Westgard rules assume QC sample results are normally distributed and TEa assumes commutability between the QC sample and patient results. None of these paradigms apply to infectious disease testing.Results from the NRL

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Çubukçu, Hikmet Can. "QC Constellation: a cutting-edge solution for risk and patient-based quality control in clinical laboratories." Clinical Chemistry and Laboratory Medicine (CCLM), May 31, 2024. http://dx.doi.org/10.1515/cclm-2024-0156.

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Abstract Objectives Clinical laboratories face limitations in implementing advanced quality control (QC) methods with existing systems. This study aimed to develop a web-based application to addresses this gap, and improve QC practices. Methods QC Constellation, a web application built using Python 3.11, integrates various statistical QC modules. These include Levey-Jennings charts with Westgard rules, sigma-metric calculations, exponentially weighted moving average (EWMA) and cumulative sum (CUSUM) charts, and method decision charts. Additionally, it offers a risk-based QC section and a patie

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