2. Principles for Assessing Analytical Quality Specifications (“AQSpecs”) and their Use in Design of Control Systems

References

• Barnett RN. Error Limits and Quality Control. Arch Path Lab Med 1989; 113: 829–830
   PubMedGoogle Scholar
• Barnett RN. Medical significance of laboratory results. Am J Clin Path 1968; 50: 671–676
   PubMed Web of Science ®Google Scholar
• Costongs G MPJ, Janson P CW, Bas B M, Hermans J, van Wersch J WJ, Brombacher PJ. Short-term and long-term intraindividualvariation and critical differences of heamatological laboratory factors. J Clin Chem Clin Biochem 1985; 23: 69–80
   PubMedGoogle Scholar
• Costongs G MPJ, Janson P CV, Bas B M, et al. Short-term and long-term intra-individual variations and critical differences of clinical chemical laboratory parameters. J Clin Chem Clin Biochem 1985; 23: 7–16
   PubMedGoogle Scholar
• Cotlove E, Harris E K, Williams GZ. Biological and analytical components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medicial implications. Clin Chem 1970; 16: 1028–1032
   PubMed Web of Science ®Google Scholar
• de Verdier C-H. The NORDKEM project and its aims. Upsala J Med Sciences 1990; 95: 173–183
   PubMed Web of Science ®Google Scholar
• de Verdier C-H, Groth T. Desirable analytical quality specifications for clinical chemistry laboratories. Clin Chem 1994; 40((1))168–170
   PubMedGoogle Scholar
• de Verdier C-H, Groth T, Hyltoft P. Petersen. Explanation of some other concepts and terms used in this report. Upsala J Med Sciences 1993; 98((3)), Chapter 11. In Press
   Google Scholar
• Dybkaer R, Jordal P J, Joergensen, et al. A quality manual for the clinical laboratory including the elements of a quality system. Proposed guidelines. Scand J Clin Lab Invest 1993; 53(Suppl 212)60–84
   Google Scholar
• Ehrmeyer S S, Laessig R H, Schell K. Use of alternative rules (other than the 1:2s) for evaluating interlaboratory performance data. Clin Chem 1988; 34: 250–255
   PubMed Web of Science ®Google Scholar
• Elevitch FR. College of American Pathologists Conference II (1976). Analytical Goals in Clinical Chemistry. College of American pathologists, Skokie, Ill 1977
   Google Scholar
• Elion-Gerritzen W. E. Requirements for analytical performance in clinical chemistry. An evaluation from the poit of view of practising physian, Thesis. Erasmus University, Rotterdam 1978
   Google Scholar
• Elion-Gerritzen WE. Analytical precision in clinical chemistry and medical decisions. Am J Clin Path 1980; 73: 183–195
   PubMedGoogle Scholar
• General criteria for the operation of testing laboratories. CEN, Bruxelles 1991; 1–13, EN 45001
   Google Scholar
• Fraser CG. Desirable standards of performance for therapeutic drug monitoring. Clin Chem 1987; 33: 387–389
   PubMed Web of Science ®Google Scholar
• Fraser CG. The application of theoretical goals based on biological variation data in clinical chemistry. Arch Pathol Lab Med 1988; 112: 404–415
   PubMed Web of Science ®Google Scholar
• Fraser CG. Biological Variation in Clinical Chemistry. An Update: Collated Data, 1988–1991. Arch Pathol Lab Med 1992; 116: 916–923
   PubMed Web of Science ®Google Scholar
• Fraser C G, Browning M CK. Deciding the optimum interval between specimen collections: Theory and nomograms. Clin Chem 1987; 33: 1436–1438
   PubMed Web of Science ®Google Scholar
• Fraser C G, Harris EK. Generation and application of data on biological variation in clinical chemistry. Crit Rev Clin Lab Sci. 1989; 27: 409–437
   PubMed Web of Science ®Google Scholar
• Fraser C G, Hyltoft P. Petersen. The importance of imprecision. Ann Clin Biochem 1991; 28: 207–211
   PubMed Web of Science ®Google Scholar
• Fraser C G, Hyltoft P Petersen, Lytken M. Larsen. Setting Analytical Goals for Random Analytical Error in Specific Clinical Monitoring Situations. Clin Chem 1990; 36: 1625–1628
   PubMed Web of Science ®Google Scholar
• Fraser C G, Hyltoft P Petersen, Ricos C, Haeckel R. Proposed Quality Specifications for Imprecision and Inaccuracy of Analytical Systems for Clinical Chemistry. Eur J Clin Chem Clin Biochem 1992; 30: 311–317
   PubMedGoogle Scholar
• Fuentes-Arderiu X, Fraser CG. Analytical goals for interference. Ann Clin Biochem 1991; 28: 393–395
   PubMedGoogle Scholar
• Geilenkeuser W-J, Kruse R, Röhle G. Ringversuche der Deutschen Gesellshaft fuer Klinische Chemie -Interpretation der Auswertung. DG Klinische Chemie 1992; 23((2))57–81
   Google Scholar
• Glick M R, Ryder K W, Jackson SA. Graphical comparisons of interference in clinical chemistry instrumentation. Clin Chem 1986; 32: 470–475
   PubMed Web of Science ®Google Scholar
• Glick JH. Expression of random analytical error as a percentage of the range of clinical interest. Clin Chem 1976; 22: 475–483
   PubMedGoogle Scholar
• Gowans E MS, Hyltoft P Petersen, Blaabjerg O, Hoerder M. Analytical goals for the acceptance of common reference intervals for laboratories throughout a geographical area. Scand J Clin Lab Invest 1988; 48: 757–764
   PubMed Web of Science ®Google Scholar
• Groth T. Methods and approaches to determine “optimal” quality for clinical chemical data. Scand J Clin Lab Invest 1980; 40(Suppl 155)47–63
   Google Scholar
• Groth T. The role of formal biodynamic models in laboratory medicine. Scand J Clin Lab Invest 1984; 40(Suppl 155)47–63
   Google Scholar
• Groth T. Biodynamic models as they relate to test selection. Clinics in Lab Med 1982; 2((4))701–715
   PubMedGoogle Scholar
• Groth T, de Verdier C-H. Transferability of Clinical Laboratory Data. Upsala J Med Sciences 1993; 98((3)), In Press
   Google Scholar
• Groth T, de Verdier C-H. Analytical quality goals and assessment to ensure transferability of laboratory results. Clin Chim Acta 1993; 222: 129–139
   PubMed Web of Science ®Google Scholar
• Groth T, Hakman M, Hällgren R, Roxin L-E, Venge P. Diagnosis, size estimation and prediction of acute myocardial infarction from S-myoglobin observations: A system analysis to assess the influence of various sources of variability. Scand J Clin Lab Invest 1980; 40(suppl 155)111–124
   Google Scholar
• Groth T, Ljunghall S, de Verdier C-H. Optimal screening for patients with hyperparathyroidism with use of serum calcium observations: A decision-theoretical analysis. Scand J Clin Lab Invest 1983; 43: 699–707
   PubMed Web of Science ®Google Scholar
• Groth T, Westgard JO. A Second generation Simulation Program for Optimizing Quality Control Design. Clin Chem 1003; 36, 1990
   Google Scholar
• Harris EK. Statistical principles underlying analytical goal-setting in clinical chemistry. Am J Clin Pathol 1979; 72: 374–382
   PubMed Web of Science ®Google Scholar
• Harris EK. Proposed goals for analytical precision and accuracy in single-point testing: theoretical basis and comparison with data from the College of American pathologists proficiency surveys. Arch Pathol Lab Med 1988; 112: 416–420
   PubMed Web of Science ®Google Scholar
• Hellsing K. SEQLA - Swedish external quality assurance in laboratory medicine - a new approach. Nycomed Workshop at XXIII Nordic Congress in Clinical Chemistry. Reykjavik August, 1922
   Google Scholar
• Høder M. Assessing Quality Requirements in Clinical Chemistry. Scand J Clin Lab Invest 1980; 40(Suppl. 155)1–144
   PubMedGoogle Scholar
• Hyltoft P Petersen, Blaabjerg O, Irjala K, Icén A, Bjøro K. External analytical quality assurance for proteins. Upsala J Med Sci. 1993; 98((3)), Chapter 5.1. In Press
   Google Scholar
• Hyltoft P Petersen, Fraser C G, Westgard J O, Lytken M. Larsen. Analytical goal-setting for monitoring patients when two analytical methods are used. Clin Chem 1992; 38((11))2256–2260
   PubMedGoogle Scholar
• Hyltoft P Petersen, Gowans E MS, Blaabjerg O, Hørder M. Analytical goals for the estimation of non-Gaussian reference intervals. Scand J Clin Lab Invest 1989; 49: 727–737
   PubMedGoogle Scholar
• Hyltoft P Petersen, Hørder M. Ways of assessing quality goals for diagnostic tests in clinical situations. Arch Pathol Lab Med 1988; 112: 435–443
   PubMedGoogle Scholar
• Hyltoft P Petersen, Hørder M. Influence of analytical quality on test results. Scand J Clin Lab 1992; 52(Suppl 208)65–94
   Google Scholar
• Hyltoft P Petersen, Hørder M, Blom M, Frimodt-Møller P, Prag J. An example of choice of test quality in clinical decision making based on two consecutive measurements. Scand J Clin Lab Invest 1984; 44(Suppl 171)47–58
   PubMedGoogle Scholar
• IFCC Scientific committee E, Buettner J, R. Boutwell JH, Broughton PMG, Bowyer RC. Approved recommendation (1983). Quality control in clinical chemistry. Part 5. External quality control. J Clin Chem Clin Biochem 1983; 21: 885–892
   PubMedGoogle Scholar
• Klee GG. Tolerance Limits for Short-Term Analytical Bias and Analytical Imprecision Derived from Clinical Assay Specificity. Clin Chem 1993; 39((7))1514–1518
   PubMedGoogle Scholar
• Koch D D, Oryall J J, Quam E F, et al. Selection of Medically Useful Quality-Control Procedures for Individual Tests Done in a Multitest Analytical System. Clin Chem 1990; 36: 230–233
   PubMed Web of Science ®Google Scholar
• Libeer J C. External Quality Assessment in Clinical Laboratories. European Perspectives: Today and Tomorrow, Antwerpen: Thesis. Universitaire Instelling, Antwerpen 1993
   Google Scholar
• Linnet K. Choosing quality-control systems to detect maximum clinically allowable analytical errors. Clin Chem 1989; 35: 284–288
   PubMed Web of Science ®Google Scholar
• Lytken M Larsen, Fraser C G, Hyltoft P. Petersen. A comparison of analytical goals for haemoglobin A1c assays derived using different strategies. Ann Clin Biochem 1991; 28: 272–278
   PubMedGoogle Scholar
• Magid E, Hyltoft P Petersen, Lytken M. Larsen. Monitoring. A note on the theory of reference changes. Scand J Clin Lab Invest 1992; 52(Suppl 208)95–104
   PubMedGoogle Scholar
• Matzen P, Hilden J, Thomsen C, Malchow-Moeller A, Juhl E. Does test quality influence the outcome of algorithmic classification of jaundiced patients?. Scand J Clin Lab Invest 1984; 44(Suppl 171)35–46
   Google Scholar
• Noerregaard K Hansen, Hyltoft P Petersen, Hangaard J, et al. Early observations of S-myoglobin in the diagnosis of acute myocardial infarction: The influence of discrimination limit, analytical quality, patient's sex and prevalence of disease. Scand J Clin Lab Invest 1986; 46: 561–569
   PubMedGoogle Scholar
• Penttilä IM, Pikkarainen R. Cooperation between clinical laboratories and labquality Ltd. for the organization of external quality control in Finland. Kliin - lab J Finnish Soc Clin Chem 1993; 10((2a))69–76
   Google Scholar
• Ricos C, Arbos MA. Quality goals for hormone testing. Ann Clin Biochem 1990; 27: 353–358
   PubMed Web of Science ®Google Scholar
• Ross J. A theoretical basis for clinically relevant profiency testing evaluation limits. Sensitivity analysis of the effect of inherent test variability on acceptable method error. Arch Pathol Lab Med 1988; 112: 421–434
   PubMedGoogle Scholar
• Skendzel L P, Barnett R N, Platt R. Medical useful criteria for analytical performance of laboratory tests. Am J Clin Pathol 1985; 83: 200–205
   PubMed Web of Science ®Google Scholar
• Stamm DA. A new concept for quality control of clinical laboratory investigations in the light of clinical requirements and based on reference method values. J Clin Chem Clin Biochem 1982; 20: 817–822
   PubMedGoogle Scholar
• Thue G, Sandberg S, Fugelli P. Clinical assessment of haemoglobin values by general practitioners related to analytical and biological variation. Scand J Clin Lab Invest 1991; 51: 453–459
   PubMed Web of Science ®Google Scholar
• Tonks DB. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963; 9: 217–233
   PubMed Web of Science ®Google Scholar
• Uldall A. Quality Development Programmes should be the Main Scope for EQA Work. EQAnews 1993; 4((3))4–5
   Google Scholar
• US Department of Health and Human Services. Medicare, Medicaid, and CLIA Programs. Regulations implementing the Clinical laboratory Improvement Admendments of 1988 (CLIA) Final Rule. Fed Regist 1992; 57: 7002–7186
   PubMedGoogle Scholar
• van Waeg G, Groth T. Allopurinol kinetics in humans as a means to assess liver function: design of a loading test. Am J Physiol 1989; 257: R237–R245
   PubMed Web of Science ®Google Scholar
• Westgard JO. Charts of Operational Process Specifications (“OPSpecs Charts”) for Assessing the Pecision, Accuracy, and Quality Control Needed to Satisfy Proficiency Testing Performance Criteria. Clin Chem 1992; 38: 1226–1233
   PubMed Web of Science ®Google Scholar
• Westgard J O, Groth T. Power functions for statistical control rules. Clin Chem 1979; 25: 863–869
   PubMed Web of Science ®Google Scholar
• Westgard J O, Groth T. Design and evaluation of statistical control procedures: Applications of a computer “Quality Control Simulator” program. Clin Chem 1981; 27: 1536–1545
   PubMedGoogle Scholar
• Westgard J O, Groth T. Design of statistical control procedures utilizing quality specifications and power functions for control rules. Proceedings of the VIIth Tenovus Workshop on Control in Clinical Endocrinology, Gaskell Kemp Wilson. Alpha-Omega Publ. Ltd., 1981
   Google Scholar
• Westgard J O, Groth T. A predictive value model for quality control: effects of the prevalence of errors on the performance of control procedures. Am J Clin Pathol 1983; 80: 49–56
   PubMedGoogle Scholar
• Westgard J O, Groth T, de Verdier C-H. Principles for developing improved quality control procedures. Scand J Clin Lab Invest 1984; 44(suppl 172)19–41
   PubMed Web of Science ®Google Scholar
• Westgard J O, Hyltoft P Petersen, Groth T. The quality costs of an analytical process. A test yield formulation of predictive value quality-costs model. Scand J Clin Lab Invest 1984; 44(Suppl 172)229–235
   Google Scholar
• Westgard J O, Hyltoft P Petersen, Wiebe A. Laboratory Process Specifications for Assuring Quality in the U.S. National Cholesterol Education Program (NCEP). Clin Chem 1991; 37: 656–661
   PubMed Web of Science ®Google Scholar
• Westgard J O, Quam E F, Barry PL. Selection grids for planning quality control procedures. J Clin Lab Sci. 1990; 3: 271–278
   Google Scholar
• Wide L, Dahlberg PA. Quality requirements of basal S-TSH assays in predicting a S-TSH response to TRH. Scand J Clin Lab Invest 1980; 40(Suppl 155)101–110
   Web of Science ®Google Scholar
• Wiebe D A, Westgard JA. Cholesterol - a Model System to Relate Medical Needs with Analytical Performance. Clin Chem 1993; 39((7))1504–1513
   PubMedGoogle Scholar
• Wiener F, Groth T, Nilsson U. A knowledge-based system for automatic interpretation of an analytical profile of complement factors. J Clin Lab Anal 1989; 3: 287–295
   PubMed Web of Science ®Google Scholar
• Wiggers P, Dalhöj J, Hyltoft P Petersen, Blaabjerg O, Høder M. Screening for haemochromatosis: influence of analytical imprecision, diagnostic limit and prevalence on test validity. Scand J Clin Lab Invest 1991; 51: 143–148
   PubMed Web of Science ®Google Scholar