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Invited Reviews

Technical quality assurance and quality control for medical laboratories: a review and proposal of a new concept to obtain integrated and validated QA/QC plans

Pages 586-600 | Received 14 Jan 2022, Accepted 08 Jun 2022, Published online: 25 Jun 2022

References

  • Sciacovelli L, Lippi G, Sumarac Z, et al. Pre-analytical quality indicators in laboratory medicine: performance of laboratories participating in the IFCC working group “laboratory errors and patient safety” project. Clin Chim Acta. 2019;497:35–40.
  • Sciacovelli L, Lippi G, Sumarac Z, 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(3):348–357.
  • Thelen MHM, Huisman W. Harmonization of accreditation to ISO15189. Clin Chem Lab Med. 2018;56(10):1637–1643.
  • Levey S, Jennings ER. The use of control charts in the clinical laboratory. Am J Clin Pathol. 1950;20(11):1059–1066.
  • Westgard JO, Barry PL, Hunt MR, et al. A multi-rule Shewhart chart for quality control in clinical chemistry. Clin Chem. 1981;27(3):493–501.
  • Lindberg DA. Collection, evaluation, and transmission of hospital laboratory data. Methods Inf Med. 1967;6(3):97–107.
  • Cembrowski GS. Use of patient data for quality control. Clin Lab Med. 1986;6(4):715–733.
  • Hoffmann RG, Waid ME. The “average of normals” method of quality control. Am J Clin Pathol. 1965;43:134–141.
  • Westgard JO, Groth T. Power functions for statistical control rules. Clin Chem. 1979;25(6):863–869.
  • Randell EW, Yenice S. Delta checks in the clinical laboratory. Crit Rev Clin Lab Sci. 2019;56(2):75–97.
  • van Rossum HH. Moving average quality control: principles, practical application and future perspectives. Clin Chem Lab Med. 2019;57(6):773–782.
  • van Rossum HH. An approach to selecting auto-verification limits and validating their error detection performance independently for pre-analytical and analytical errors. Clin Chim Acta. 2020;508:130–136.
  • Ng D, Polito FA, Cervinski MA. Optimization of a moving averages program using a simulated annealing algorithm: the goal is to monitor the process not the patients. Clin Chem. 2016;62(10):1361–1371.
  • Fleming JK, Katayev A. Changing the paradigm of laboratory quality control through implementation of real-time test results monitoring: for patients by patients. Clin Biochem. 2015;48(7–8):508–513.
  • van Rossum HH, Kemperman H. A method for optimization and validation of moving average as continuous analytical quality control instrument demonstrated for creatinine. Clin Chim Acta. 2016;457:1–7.
  • van Rossum HH, Kemperman H. Optimization and validation of moving average quality control procedures using bias detection curves and moving average validation charts. Clin Chem Lab Med. 2017;55(2):218–224.
  • Tan RZ, Markus C, Loh TP. Impact of delta check time intervals on error detection capability. Clin Chem Lab Med. 2020;58(3):384–389.
  • Tan RZ, Markus C, Loh TP. Relationship between biological variation and delta check rules performance. Clin Biochem. 2020;80:42–47.
  • Rossum HH, Kemperman H. Implementation and application of moving average as continuous analytical quality control instrument demonstrated for 24 routine chemistry assays. Clin Chem Lab Med. 2017;55(8):1142–1151.
  • van Rossum HH, van den Broek D. Design and implementation of quality control plans that integrate moving average and internal quality control: incorporating the best of both worlds. Clin Chem Lab Med. 2019;57(9):1329–1338.
  • van Rossum HH. When internal quality control is insufficient or inefficient: consider patient-based real-time quality control! Ann Clin Biochem. 2020;57(3):198–201.
  • Plebani M, Sciacovelli L, Chiozza ML, et al. Once upon a time: a tale of ISO 15189 accreditation. Clin Chem Lab Med. 2015;53(8):1127–1129.
  • Aita A, Sciacovelli L, Plebani M. Extra-analytical quality indicators – where to now? Clin Chem Lab Med. 2018;57(1):127–133.
  • Parvin CA. Assessing the impact of the frequency of quality control testing on the quality of reported patient results. Clin Chem. 2008;54(12):2049–2054.
  • Westgard S, Bayat H, Westgard JO. Analytical sigma metrics: a review of six sigma implementation tools for medical laboratories. Biochem Med. 2018;28(2):020502.
  • Rosenbaum MW, Flood JG, Melanson SEF, et al. Quality control practices for chemistry and immunochemistry in a cohort of 21 large academic medical centers. Am J Clin Pathol. 2018;150(2):96–104.
  • van Rossum HH, Bietenbeck A, Cervinski MA, et al. Benefits, limitations, and controversies on patient-based real-time quality control (PBRTQC) and the evidence behind the practice. Clin Chem Lab Med. 2021.
  • Parvin CA, Gronowski AM. Effect of analytical run length on quality-control (QC) performance and the QC planning process. Clin Chem. 1997;43(11):2149–2154.
  • Yago M, Alcover S. Selecting statistical procedures for quality control planning based on risk management. Clin Chem. 2016;62(7):959–965.
  • Bayat H. Selecting multi-rule quality control procedures based on patient risk. Clin Chem Lab Med. 2017;55(11):1702–1708.
  • Westgard JO, Bayat H, Westgard SA. Planning risk-based SQC schedules for bracketed operation of continuous production analyzers. Clin Chem. 2018;64(2):289–296.
  • Poh DKH, Lim CY, Tan RZ, et al. Internal quality control: moving average algorithms outperform Westgard rules. Clin Biochem. 2021;98:63–69.
  • Bayat H, Westgard SA, Westgard JO. Multirule procedures vs moving average algorithms for IQC: an appropriate comparison reveals how best to combine their strengths. Clin Biochem. 2022;102:50–55.
  • Lim CY, Markus C, Tan RZ, et al. Letter to the editor: on moving average and internal quality control. Clin Biochem. 2022;103:32–34.
  • Badrick T, Graham P. Can a combination of average of normals and “real time” external quality assurance replace internal quality control? Clin Chem Lab Med. 2018;56(4):549–553.
  • Badrick T. Integrating quality control and external quality assurance. Clin Biochem. 2021;95:15–27.
  • Linnet K. The exponentially weighted moving average (EWMA) rule compared with traditionally used quality control rules. Clin Chem Lab Med. 2006;44(4):396–399.
  • Bull BS, Elashoff RM, Heilbron DC, et al. A study of various estimators for the derivation of quality control procedures from patient erythrocyte indices. Am J Clin Pathol. 1974;61(4):473–481.
  • Liu J, Tan CH, Loh TP, et al. Verification of out-of-control situations detected by “average of normal” approach. Clin Biochem. 2016;49(16–17):1248–1253.
  • Badrick T, Cervinski M, Loh TP. A primer on patient-based quality control techniques. Clin Biochem. 2019;64:1–5.
  • Badrick T, Bietenbeck A, Katayev A, et al. Implementation of patient-based real-time quality control. Crit Rev Clin Lab Sci. 2020;57(8):532–547.
  • Thienpont LM, Stöckl D. Percentiler and flagger – low-cost, on-line monitoring of laboratory and manufacturer data and significant surplus to current external quality assessment. J Lab Med. 2018;42(6):289–296.
  • van Rossum HH, Kemperman H. Moving average for continuous quality control: time to move to implementation in daily practice? Clin Chem. 2017;63(5):1041–1043.
  • Badrick T, Bietenbeck A, Cervinski MA, et al. Patient-based real-time quality control: review and recommendations. Clin Chem. 2019;65(8):962–971.
  • Badrick T, Bietenbeck A, Katayev A, et al. Patient-based real time QC. Clin Chem. 2020;66(9):1140–1145.
  • Loh TP, Bietenbeck A, Cervinski MA, et al. Recommendation for performance verification of patient-based real-time quality control. Clin Chem Lab Med. 2020;58(8):1205–1213.
  • Loh TP, Cervinski MA, Katayev A, et al. Recommendations for laboratory informatics specifications needed for the application of patient-based real time quality control. Clin Chim Acta. 2019;495:625–629.
  • MA Generator; 2019. Available from: www.huvaros.com
  • Lukic V, Ignjatovic S. Optimizing moving average control procedures for small-volume laboratories: can it be done? Biochem Med. 2019;29(3):030710.
  • van Rossum HH, van den Broek D. Ten-month evaluation of the routine application of patient moving average for real-time quality control in a hospital setting. J Appl Lab Med. 2020;5(6):1184–1193.
  • Bietenbeck A, Cervinski MA, Katayev A, et al. Understanding patient-based real-time quality control using simulation modeling. Clin Chem. 2020;66(8):1072–1083.
  • Liu J, Tan CH, Badrick T, et al. Moving sum of number of positive patient result as a quality control tool. Clin Chem Lab Med. 2017;55(11):1709–1714.
  • Liu J, Tan CH, Badrick T, et al. Moving standard deviation and moving sum of outliers as quality tools for monitoring analytical precision. Clin Biochem. 2018;52:112–116.
  • Smith JD, Badrick T, Bowling F. A direct comparison of patient-based real-time quality control techniques: the importance of the analyte distribution. Ann Clin Biochem. 2020;57(3):206–214.
  • Duan X, Wang B, Zhu J, et al. Regression-adjusted real-time quality control. Clin Chem. 2021;67(10):1342–1350.
  • Cembrowski GS, Xu Q, Cervinski MA. Average of patient deltas: patient-based quality control utilizing the mean within-patient analyte variation. Clin Chem. 2021;67(7):1019–1029.
  • Randell EW, Yenice S, Khine Wamono AA, et al. Autoverification of test results in the core clinical laboratory. Clin Biochem. 2019;73:11–25.
  • Markus C, Tan RZ, Loh TP. Evidence-based approach to setting delta check rules. Crit Rev Clin Lab Sci. 2021;58(1):49–59.
  • van Rossum HH. Optimization and validation of limit check error-detection performance using a laboratory-specific data-simulation approach: a prerequisite for an evidence-based practice. J Appl Lab Med. 2022;7(2):467–479.
  • Cembrowski GS, Chandler EP, Westgard JO. Assessment of “average of normals” quality control procedures and guidelines for implementation. Am J Clin Pathol. 1984;81(4):492–499.
  • Ye JJ, Ingels SC, Parvin CA. Performance evaluation and planning for patient-based quality control procedures. Am J Clin Pathol. 2000;113(2):240–248.
  • van Rossum HH. Optimization and validation of limit check error-detection performance using a laboratory-specific data-simulation approach: a prerequisite for an evidence-based practice. J Appl Lab Med. 2022;7(2):467–479.
  • van Rossum HH. Demonstrating the feasibility of accurately and reliably correcting potassium results for mildly hemolytic samples using a new experimental design. Clin Chim Acta. 2021;522:83–87.
  • Colak S, Tasdemir O, van der Schaaf M, et al. Design, validation and performance of aspartate aminotransferase- and lactate dehydrogenase-reporting algorithms for haemolysed specimens including correction within quality specifications. Ann Clin Biochem. 2019.
  • Janssens PMW, Pot MW, Wouters M, et al. What extreme laboratory values can be obtained that (some) patients can survive with? Scand J Clin Lab Invest. 2022;82(1):50–58.
  • Wu J, Pan M, Ouyang H, et al. Establishing and evaluating autoverification rules with intelligent guidelines for arterial blood gas analysis in a clinical laboratory. SLAS Technol. 2018;23(6):631–640.
  • Li J, Cheng B, Ouyang H, et al. Designing and evaluating autoverification rules for thyroid function profiles and sex hormone tests. Ann Clin Biochem. 2018;55(2):254–263.
  • Katayev A, Fleming JK. Past, present, and future of laboratory quality control: patient- based real-time quality control or when getting more quality at less cost is not wishful thinking. J Lab Precis Med. 2020;5:28–28.
  • Kazmierczak SC. Laboratory quality control: using patient data to assess analytical performance. Clin Chem Lab Med. 2003;41(5):617–627.
  • Westgard JO. Six sigma quality design & control. 2nd ed. Maddison (WI): Westgard QC, Inc.; 2006.
  • Schoenmakers CH, Naus AJ, Vermeer HJ, et al. Practical application of sigma metrics QC procedures in clinical chemistry. Clin Chem Lab Med. 2011;49(11):1837–1843.

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