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Volumn 53, Issue 1, 2016, Pages 32-50

Quality control review: implementing a scientifically based quality control system

Author keywords

Quality control; quality management; Six Sigma

Indexed keywords

MEASUREMENT ERROR; MONITORING; PLANNING; PRIORITY JOURNAL; QUALITY CONTROL PROCEDURES; REVIEW; RISK ASSESSMENT; VALIDATION STUDY; HEALTH CARE QUALITY; HUMAN; LABORATORY TEST; PROCEDURES; STATISTICS;

EID: 84950327173     PISSN: 00045632     EISSN: 17581001     Source Type: Journal    
DOI: 10.1177/0004563215597248     Document Type: Review
Times cited : (72)

References (63)
  • 1
    • 0242721662 scopus 로고    scopus 로고
    • Internal quality control: planning and implementation strategies
    • J.O.Westgard. Internal quality control: planning and implementation strategies. Ann Clin Biochem2003; 40: 593–611.
    • (2003) Ann Clin Biochem , vol.40 , pp. 593-611
    • Westgard, J.O.1
  • 3
    • 0037538649 scopus 로고    scopus 로고
    • Medicare, medicaid, and CLIA programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final Rule
    • US Centers for Medicare & Medicaid Services (CMS). Medicare, medicaid, and CLIA programs: laboratory requirements relating to quality systems and certain personnel qualifications. Final Rule. Fed Regist2003; 16: 3650–3714.
    • (2003) Fed Regist , vol.16 , pp. 3650-3714
  • 4
    • 84872974503 scopus 로고    scopus 로고
    • The CCLM contribution to improvements in quality and patient safety
    • M.Plebani. The CCLM contribution to improvements in quality and patient safety. Clin Chem Lab Med2013; 51: 39–46.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 39-46
    • Plebani, M.1
  • 5
    • 84882992273 scopus 로고    scopus 로고
    • Can current analytical quality performance in UK laboratories support evidence-based guidelines for diabetes and ischaemic heart disease? A pilot study and a proposal
    • N.JassamJ.Yundt-PachecoJ.Jansen. Can current analytical quality performance in UK laboratories support evidence-based guidelines for diabetes and ischaemic heart disease? A pilot study and a proposal. Clin Chem Lab Med2013; 51: 1579–1584.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 1579-1584
    • Jassam, N.1    Yundt-Pacheco, J.2    Jansen, J.3
  • 9
    • 0027942080 scopus 로고
    • Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria
    • J.O.WestgardJ.J.SeehaferP.L.Barry. Allowable imprecision for laboratory tests based on clinical and analytical test outcome criteria. Clin Chem1994; 40: 1909–1914.
    • (1994) Clin Chem , vol.40 , pp. 1909-1914
    • Westgard, J.O.1    Seehafer, J.J.2    Barry, P.L.3
  • 10
    • 84871995815 scopus 로고    scopus 로고
    • Standards of Medical Care in Diabetes – 2013
    • American Diabetes Association. Standards of Medical Care in Diabetes – 2013. Diabetes Care2013; 36: S11–S66.
    • (2013) Diabetes Care , vol.36 , pp. S11-S66
  • 11
    • 84950347124 scopus 로고    scopus 로고
    • NGSP website. www.ngsp.org (accessed 5 April 2015)
  • 13
    • 0000068103 scopus 로고    scopus 로고
    • Special issue: strategies to set global analytical quality specifications in laboratory medicine
    • P.H.PetersenC.G.FraserA.KallnerD.Kenny. Special issue: strategies to set global analytical quality specifications in laboratory medicine. Scand J Clin Lab Invest1999; 59: 473–585.
    • (1999) Scand J Clin Lab Invest , vol.59 , pp. 473-585
    • Petersen, P.H.1    Fraser, C.G.2    Kallner, A.3    Kenny, D.4
  • 14
    • 84929092769 scopus 로고    scopus 로고
    • Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine
    • S.SandbergC.G.FraserA.R.Horvath. Defining analytical performance specifications: consensus statement from the 1st strategic conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med2015; 53: 833–835.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 833-835
    • Sandberg, S.1    Fraser, C.G.2    Horvath, A.R.3
  • 15
    • 84950347125 scopus 로고    scopus 로고
    • Special issue: 1st EFLM Strategic Conference Defining analytical performance goals – 15 years after the Stockholm conference. Clin Chem Lab Med 2015; 53: 829–958
    • Special issue: 1st EFLM Strategic Conference Defining analytical performance goals – 15 years after the Stockholm conference. Clin Chem Lab Med 2015; 53: 829–958
  • 16
    • 84920872578 scopus 로고    scopus 로고
    • Biological variation – reliable data is essential
    • A.K.AarsandT.RoraasS.Sandberg. Biological variation – reliable data is essential. Clin Chem Lab Med2015; 53: 153–154.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 153-154
    • Aarsand, A.K.1    Roraas, T.2    Sandberg, S.3
  • 18
    • 80052247980 scopus 로고    scopus 로고
    • Gross overestimation of total allowable error based on biological variation
    • W.P.Oosterhuis. Gross overestimation of total allowable error based on biological variation. Clin Chem2011; 57: 1334–1336.
    • (2011) Clin Chem , vol.57 , pp. 1334-1336
    • Oosterhuis, W.P.1
  • 19
    • 0027457005 scopus 로고
    • Quality goals in external quality assessment are best based on biology
    • C.G.FraserH.Petersen. Quality goals in external quality assessment are best based on biology. Scand J Clin Lab Invest1993; 53(Suppl 212): 8–9.
    • (1993) Scand J Clin Lab Invest , vol.53 , pp. 8-9
    • Fraser, C.G.1    Petersen, H.2
  • 20
    • 0024238335 scopus 로고
    • Analytical goals for the acceptance of common reference intervals for laboratories throughout a geographical area
    • E.M.S.GowansP.H.PetersenO.Blassbjerg. Analytical goals for the acceptance of common reference intervals for laboratories throughout a geographical area. Scand J Clin Lab Invest1988; 48: 757–764.
    • (1988) Scand J Clin Lab Invest , vol.48 , pp. 757-764
    • Gowans, E.M.S.1    Petersen, P.H.2    Blassbjerg, O.3
  • 22
    • 84929103818 scopus 로고    scopus 로고
    • Proposal for the modification of the conventional model for establishing performance specifications
    • W.P.OosterhuisS.Sandberg. Proposal for the modification of the conventional model for establishing performance specifications. Clin Chem Lab Med2015; 53: 925–937.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 925-937
    • Oosterhuis, W.P.1    Sandberg, S.2
  • 23
    • 84950347126 scopus 로고    scopus 로고
    • Westgard Web. Survey on use of analytical goals, www.westgard.com/global-goal-results.htm (accessed 1 July 2015)
  • 25
    • 4344681290 scopus 로고    scopus 로고
    • Metrological traceability of calibration in the estimation and use of common medical decision-making criteria
    • L.M.ThienpontK.Van UtfangheD.R.Cabaleiro. Metrological traceability of calibration in the estimation and use of common medical decision-making criteria. Clin Chem Lab Med2004; 42: 842–850.
    • (2004) Clin Chem Lab Med , vol.42 , pp. 842-850
    • Thienpont, L.M.1    Van Utfanghe, K.2    Cabaleiro, D.R.3
  • 26
    • 84950347127 scopus 로고    scopus 로고
    • NGSP website, www.ngsp.org (accessed 1 December 2014)
  • 27
    • 79961074096 scopus 로고    scopus 로고
    • Roadmap for harmonization of clinical laboratory measurement procedures
    • W.G.MillerG.L.MyersM.L.Gantzer. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem2011; 57: 1108–1117.
    • (2011) Clin Chem , vol.57 , pp. 1108-1117
    • Miller, W.G.1    Myers, G.L.2    Gantzer, M.L.3
  • 31
    • 0004263460 scopus 로고    scopus 로고
    • 3rd edn, [Chapter 16]. Madison WI: Westgard QC, Inc
    • J.O.Westgard. Basic method validation, 3rd edn. [Chapter 16]. Madison WI: Westgard QC, Inc., 2008.
    • (2008) Basic method validation
    • Westgard, J.O.1
  • 32
    • 84939978813 scopus 로고    scopus 로고
    • A new approach to calculating the Sigma Metric in clinical laboratories
    • A.CoskunJ.SerteserM.Kilercik. A new approach to calculating the Sigma Metric in clinical laboratories. Accred Qual Assur2015; 20: 147–152.
    • (2015) Accred Qual Assur , vol.20 , pp. 147-152
    • Coskun, A.1    Serteser, J.2    Kilercik, M.3
  • 33
    • 84905227565 scopus 로고    scopus 로고
    • Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria
    • E.Lenters-WestraR.J.Slingerland. Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria. Clin Chem2014; 60: 1062–1072.
    • (2014) Clin Chem , vol.60 , pp. 1062-1072
    • Lenters-Westra, E.1    Slingerland, R.J.2
  • 35
    • 84872482109 scopus 로고    scopus 로고
    • Prioritizing risk analysis quality control plans based on sigma-metrics
    • S.A.Westgard. Prioritizing risk analysis quality control plans based on sigma-metrics. Clin Lab Med2013; 33: 41–53.
    • (2013) Clin Lab Med , vol.33 , pp. 41-53
    • Westgard, S.A.1
  • 36
    • 84872436546 scopus 로고    scopus 로고
    • Statistical quality control procedures
    • J.O.Westgard. Statistical quality control procedures. Clin Lab Med2013; 33: 111–124.
    • (2013) Clin Lab Med , vol.33 , pp. 111-124
    • Westgard, J.O.1
  • 38
    • 84905278069 scopus 로고    scopus 로고
    • Utilization of assay performance characteristics to estimate hemoglobin A1c result reliability
    • A.WoodworthN.Korpi-SteinerJ.J.Miller. Utilization of assay performance characteristics to estimate hemoglobin A1c result reliability. Clin Chem2014; 60: 1073–1079.
    • (2014) Clin Chem , vol.60 , pp. 1073-1079
    • Woodworth, A.1    Korpi-Steiner, N.2    Miller, J.J.3
  • 39
  • 40
    • 84929075479 scopus 로고    scopus 로고
    • How to define a significant deviation from the expected internal quality control result
    • F.CeriottiD.BrugnoniS.Mattioli. How to define a significant deviation from the expected internal quality control result. Clin Chem Lab Med2015; 53: 913–918.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 913-918
    • Ceriotti, F.1    Brugnoni, D.2    Mattioli, S.3
  • 41
    • 84950347128 scopus 로고    scopus 로고
    • US Department of Health and Human Services. Individualized Quality Control Plan: A Step-by-Step Guide for Developing an IQCP. Atlanta GA: CDC, www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/IQCP-Workbook.pdf (2015, accessed 1 July 2015)
  • 43
    • 84939986219 scopus 로고    scopus 로고
    • Changing the paradigm of laboratory quality control through implementation of real-time test results monitoring: for patients by patients
    • J.K.FlemingA.Katayev. Changing the paradigm of laboratory quality control through implementation of real-time test results monitoring: for patients by patients. Clin Biochem2015; 48: 508–513.
    • (2015) Clin Biochem , vol.48 , pp. 508-513
    • Fleming, J.K.1    Katayev, A.2
  • 44
    • 84950347129 scopus 로고    scopus 로고
    • Hitting a moving target: opportunities and challenges in using moving averages quality control
    • Nov: 4–5
    • M.A.Cervinski. Hitting a moving target: opportunities and challenges in using moving averages quality control. Clin Lab News2014. Nov: 4–5.
    • (2014) Clin Lab News
    • Cervinski, M.A.1
  • 45
    • 0038229155 scopus 로고
    • The average of normal-method of quality control
    • R.G.HoffmanM.E.Waid. The average of normal-method of quality control. Am J Clin Pathol1955; 43: 134–141.
    • (1955) Am J Clin Pathol , vol.43 , pp. 134-141
    • Hoffman, R.G.1    Waid, M.E.2
  • 46
    • 0021342509 scopus 로고
    • Assessment of average of normal-quality control procedures and guidelines for implementation
    • G.S.CembrowskiE.P.ChandlerJ.O.Westgard. Assessment of average of normal-quality control procedures and guidelines for implementation. Am J Clin Pathol1984; 81: 492–499.
    • (1984) Am J Clin Pathol , vol.81 , pp. 492-499
    • Cembrowski, G.S.1    Chandler, E.P.2    Westgard, J.O.3
  • 47
    • 0029904528 scopus 로고    scopus 로고
    • Design and assessment of average of normal (AON) patient data algorithms to maximize run lengths for automatic process control
    • J.O.WestgardF.A.SmithP.J.Mountain. Design and assessment of average of normal (AON) patient data algorithms to maximize run lengths for automatic process control. Clin Chem1996; 42: 1683–1688.
    • (1996) Clin Chem , vol.42 , pp. 1683-1688
    • Westgard, J.O.1    Smith, F.A.2    Mountain, P.J.3
  • 48
    • 78650973954 scopus 로고    scopus 로고
    • Commutability limitations influence quality control results with different reagent lots
    • W.G.MillerA.ErekT.D.Cunningham. Commutability limitations influence quality control results with different reagent lots. Clin Chem2011; 57: 76–83.
    • (2011) Clin Chem , vol.57 , pp. 76-83
    • Miller, W.G.1    Erek, A.2    Cunningham, T.D.3
  • 49
    • 84992054228 scopus 로고    scopus 로고
    • Wayne PA: Clinical and Laboratory Standards Institute
    • CLSI EP26A. User evaluation of between-reagent lot variation, Wayne PA: Clinical and Laboratory Standards Institute, 2013.
    • (2013) User evaluation of between-reagent lot variation
  • 50
    • 57149117363 scopus 로고    scopus 로고
    • Assessing the impact of frequency of quality control testing on the quality of reported patient results
    • C.Parvin. Assessing the impact of frequency of quality control testing on the quality of reported patient results. Clin Chem2008; 54: 2049–2054.
    • (2008) Clin Chem , vol.54 , pp. 2049-2054
    • Parvin, C.1
  • 51
    • 84872461150 scopus 로고    scopus 로고
    • Validating the performance of QC procedures
    • J.Yundt-PachecoC.Parvin. Validating the performance of QC procedures. Clin Lab Med2013; 33: 75–88.
    • (2013) Clin Lab Med , vol.33 , pp. 75-88
    • Yundt-Pacheco, J.1    Parvin, C.2
  • 52
    • 80755169610 scopus 로고    scopus 로고
    • Practical application of sigma metrics QC procedures in clinical chemistry
    • C.H.H.SchoenmarkersA.J.M.NausH.J.Vermeer. Practical application of sigma metrics QC procedures in clinical chemistry. Clin Chem Lab Med2011; 49: 1837–1843.
    • (2011) Clin Chem Lab Med , vol.49 , pp. 1837-1843
    • Schoenmarkers, C.H.H.1    Naus, A.J.M.2    Vermeer, H.J.3
  • 53
    • 84892785486 scopus 로고    scopus 로고
    • Internal quality control: best practice
    • H.KinnsS.PitkinD.Housley. Internal quality control: best practice. J Clin Pathol2013; 66: 1027–1032.
    • (2013) J Clin Pathol , vol.66 , pp. 1027-1032
    • Kinns, H.1    Pitkin, S.2    Housley, D.3
  • 55
    • 74549198676 scopus 로고    scopus 로고
    • Managing quality vs. measuring uncertainty in the medical laboratory
    • J.O.Westgard. Managing quality vs. measuring uncertainty in the medical laboratory. Clin Chem Lab Med2010; 48: 31–40.
    • (2010) Clin Chem Lab Med , vol.48 , pp. 31-40
    • Westgard, J.O.1
  • 56
    • 33644654751 scopus 로고    scopus 로고
    • The quality of laboratory testing today: an assessment of σ metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance
    • J.O.WestgardS.A.Westgard. The quality of laboratory testing today: an assessment of σ metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance. Am J Clin Pathol2006; 125: 343–354.
    • (2006) Am J Clin Pathol , vol.125 , pp. 343-354
    • Westgard, J.O.1    Westgard, S.A.2
  • 57
    • 84941197807 scopus 로고    scopus 로고
    • Assessing quality on the sigma scale from proficiency testing and external quality assessment surveys
    • Epub ahead of print 11 February 2015. 10.1515/cclm-2014-1241
    • J.O.WestgardS.A.Westgard. Assessing quality on the sigma scale from proficiency testing and external quality assessment surveys. Clin Chem Lab Med. Epub ahead of print 11 February 2015. DOI: 10.1515/cclm-2014-1241.
    • Clin Chem Lab Med
    • Westgard, J.O.1    Westgard, S.A.2
  • 58
    • 84929000266 scopus 로고    scopus 로고
    • Investigation of 2 models to set and evaluate quality targets for HbA1c: Biological variation and sigma-metrics
    • C.WeykampG.JohnP.Gillery. Investigation of 2 models to set and evaluate quality targets for HbA1c: Biological variation and sigma-metrics. Clin Chem2015; 61: 752–759.
    • (2015) Clin Chem , vol.61 , pp. 752-759
    • Weykamp, C.1    John, G.2    Gillery, P.3
  • 60
    • 0034037168 scopus 로고    scopus 로고
    • Evaluating laboratory performance on quality indicators with the six sigma scale
    • D.NevalainenL.BerteC.Kraft. Evaluating laboratory performance on quality indicators with the six sigma scale. Arch Pathol Lab Med2000; 124: 516–519.
    • (2000) Arch Pathol Lab Med , vol.124 , pp. 516-519
    • Nevalainen, D.1    Berte, L.2    Kraft, C.3
  • 61
    • 84929104899 scopus 로고    scopus 로고
    • Performance criteria and quality indicators for the pre-analytical phase
    • M.PlebaniL.SciacovelliA.Aita. Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med2015; 53: 943–948.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 943-948
    • Plebani, M.1    Sciacovelli, L.2    Aita, A.3
  • 62
    • 84929094004 scopus 로고    scopus 로고
    • Performance criteria of the post-analytical phase
    • K.Sikaris. Performance criteria of the post-analytical phase. Clin Chem Lab Med2015; 53: 949–958.
    • (2015) Clin Chem Lab Med , vol.53 , pp. 949-958
    • Sikaris, K.1


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