Establishment of outcome-related analytic performance goals

Clinical Chemistry

Volumn 56, Issue 5, 2010, Pages 714-722

  Klee, George G ^a  

^a MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BILIRUBIN; CALCIUM; CHEMICAL COMPOUND; CHOLESTEROL; CREATININE; GLUCOSE; HEMOGLOBIN; HYDROCORTISONE; IRON; PHOSPHORUS; POTASSIUM; PROTEIN; SODIUM; THYROXINE; TRIACYLGLYCEROL;

ACCREDITATION; ANALYTIC METHOD; BLOOD EXAMINATION; CELL VOLUME; CLINICAL CHEMISTRY; CLINICAL LABORATORY; ERYTHROCYTE; HEALTH CARE PERSONNEL; HEMATOCRIT; HUMAN; LEUKOCYTE; MEDICAL DECISION MAKING; OUTCOME ASSESSMENT; PERFORMANCE; PRACTICE GUIDELINE; QUALITY CONTROL; REVIEW; VALIDATION STUDY;

DECISION SUPPORT TECHNIQUES; GUIDELINES AS TOPIC; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; QUALITY CONTROL;

EID: 77951752784     PISSN: 00099147     EISSN: 15308561     Source Type: Journal    
DOI: 10.1373/clinchem.2009.133660     Document Type: Review

References (42)

1. CDC. Current CLIA regulations (including all changes through 01/24/2004). http://www.cdc.gov/clia/regs/toc.aspx (Accessed November 2009).
2. Westgard JO, Klee GG. Quality management. 4th ed. St. Louis: Elsevier Saunders; 2006. p 485-529.
3. Fraser CG. General strategies to set quality specifications for reliability performance characteristics. Scand J Clin Lab Invest 1999;59:487-490 (Pubitemid 30056738)
4. Dhatt GS, Agarwal MM, Bishawi B, Gill J. Implementing the Stockholm Conference hierarchy of objective quality criteria in a routine laboratory. Clin Chem Lab Med 2007;45:549-552 (Pubitemid 46632225)
5. Fraser CG, Kallner A, Kenny D, Petersen PH. Introduction: strategies to set global quality specifications in laboratory medicine. Scand J Clin Lab Invest 1999;59:477-478 (Pubitemid 30056735)
6. Jones BA, Bekeris LG, Nakhleh RE, Walsh MK, Valenstein PN. Physician satisfaction with clinical laboratory services: a College of American Pathologists Q-probes study of 138 institutions. Arch Pathol Lab Med 2009;133:38-43.
7. Plebani M. Quality specifications: self pleasure for clinical laboratories or added value for patient management? Clin Chem Lab Med 2007;45:462-466
8. Werner M. Linking analytic performance goals to medical outcome. Clin Chim Acta 1997;260:99-115. (Pubitemid 27199298)
9. Sciacovelli L, Secchiero S, Zardo L, Plebani M. External quality assessment schemes: need for recognised requirements. Clin Chim Acta 2001;309:183-199 (Pubitemid 32601963)
10. Westgard QC. Rilibak: quality goals the German way. http://www.westgard. com/rilibak-2.htm (Accessed March 2010).
11. Fraser CG, Hyltoft Petersen P, Libeer JC, Ricos C. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34(Pt 1):8-12. (Pubitemid 27067864)
12. Sciacovelli L, Zardo L, Secchiero S, Plebani M. Quality specifications in EQA schemes: from theory to practice. Clin Chim Acta 2004;346:87-97. (Pubitemid 38952694)
13. Gowans EM, Hyltoft Petersen P, Blaabjerg O, Horder 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 (Pubitemid 19005823)
14. Fraser CG, Petersen PH. Analytical performance characteristics should be judged against objective quality specifications. Clin Chem 1999;45:321-323
15. Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biological variation: pros, cons and progress. Scand J Clin Lab Invest 1999;59:491-500. (Pubitemid 30056739)
16. Barnett RN. Medical significance of laboratory results. Am J Clin Pathol 1968;50:671-676
17. Skendzel LP. How physicians use laboratory tests. JAMA 1978;239:1077-1080 (Pubitemid 8290957)
18. Skendzel LP, Barnett RN, Platt R. Medically useful criteria for analytic performance of laboratory tests. Am J Clin Pathol 1985;83:200-205 (Pubitemid 15128847)
19. 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
20. Skeie S, Thue G, Sandberg S. Patient-derived quality specifications for instruments used in selfmonitoring of blood glucose. Clin Chem 2001;47:67-73. (Pubitemid 32064277)
21. Bais R. What information should manufacturers provide on their procedures? Clin Chem 2006;52:1624-1625
22. Burman KD. Commentary: discordant measurements of serum triiodothyronine (T4), thyroxine (T3) and thyroid-stimulating hormone (TSH). Clin Chem 2008;54:1246.
23. Snow CF. Laboratory diagnosis of vitamin B12 and folate deficiency: a guide for the primary care physician. Arch Intern Med 1999;159:1289-1298
24. Cohen J, Ward G, Prins J, Jones M, Venkatesh B. Variability of cortisol assays can confound the diagnosis of adrenal insufficiency in the critically ill population. Intensive Care Med 2006;32:1901-1905 (Pubitemid 44607383)
25. Herold DA, Fitzgerald RL. Immunoassays for testosterone in women: better than a guess? Clin Chem 2003;49:1250-1251
26. Matsumoto AM, Bremner WJ. Serum testosterone assays: accuracy matters. J Clin Endocrinol Metab 2004;89:520-524
27. Rosner W, Auchus RJ, Azziz R, Sluss PM, Raff H. Position statement: utility, limitations, and pitfalls in measuring testosterone: an Endocrine Society position statement. J Clin Endocrinol Metab 2007;92:405-413 (Pubitemid 46255268)
28. Vesper HW, Botelho JC, Shacklady C, Smith A, Myers GL. CDC project on standardizing steroid hormone measurements. Steroids 2008;73:1286-1292
29. Klee GG, Schryver PG, Kisabeth RM. Analytic bias specifications based on the analysis of effects on performance of medical guidelines. Scand J Clin Lab Invest 1999;59:509-512 (Pubitemid 30056741)
30. Shermock KM, Connor JT, Lavallee DC, Streiff MB. Clinical decision-making as the basis for assessing agreement between measures of the International Normalized Ratio. J Thromb Haemost 2009;7:87-93.
31. Klee G. A conceptual model for establishing tolerance limits for analytic bias and imprecision based on variations in population test distributions. Clin Chim Acta 1997;260:175-188 (Pubitemid 27199303)
32. Klee GG, Schryver, P. Quality Assurance for basic haematology cell counts. In: Rowan RM, van Assendelft OW, Preston FE, eds. Advanced laboratory methods in haematology, New York: Arnold; 2002. p 3-17.
33. Gallaher PM, Mobley RL, Klee GG, Schryver P, preparers. The impact of calibration error in medical decision making. Final report. [Gaithersburg, MD]: National Institute of Standards and Technology, Chemical Science and Technology Laboratory; 2004. Report nr: Planning report 04-11 Available at: www.nist.gov/director/prog-ofc/report04-1.pdf.
34. McNair P, Brender J, Talmon J. Computer-aided test selection and result validation: opportunities and pitfalls. Clin Chim Acta 1998;278:243-255 (Pubitemid 29050847)
35. Sutton AJ, Cooper NJ, Goodacre S, Stevenson M. Integration of meta-analysis and economic decision modeling for evaluating diagnostic tests. Med Decis Making 2008;28:650-667
36. Petersen PH, de Verdier CH, Groth T, Fraser CG, Blaabjerg O, Horder M. The influence of analytical bias on diagnostic misclassifications. Clin Chim Acta 1997;260:189-206. (Pubitemid 27199304)
37. Egmont-Petersen M, Talmon JL, Hasman A. Robustness metrics for measuring the influence of additive noise on the performance of statistical classifiers. Int J Med Inform 1997;46:103-112 (Pubitemid 27421273)
38. McNair P, Brender J. Information enhancement in clinical decision making by controlled data generation. Scand J Clin Lab Invest Suppl 1990;202:112-119 (Pubitemid 20376999)
39. Vickers AJ, Cronin AM, Elkin EB, Gonen M. Extensions to decision curve analysis, a novel method for evaluating diagnostic tests, prediction models and molecular markers. BMC Med Inform Decis Mak 2008;8:53.
40. Chu A, Ahn H, Halwan B, Kalmin B, Artifon EL, Barkun A, et al. A decision support system to facilitate management of patients with acute gastrointestinal bleeding. Artif Intell Med 2008;42:247-259
41. Ritchie RF. A knowledge-based system to aid with the clinical interpretation of complex serum protein data. Clin Chem Lab Med 2001;39:1045-1053
42. Klee GG. Clinical interpretation of reference intervals and reference limits: a plea for assay harmonization. Clin Chem Lab Med 2004;42:752-757