Quality Management

Ron B. Schifman; George Cembrowski; Donna Wolk

doi:10.1128/9781555817695.ch20

Chapter 20 : Quality Management

Authors: Ron B. Schifman, George Cembrowski, Donna Wolk

Content Type: Reference

Publication Year: 2004

Category: Clinical Microbiology

Book DOI: 10.1128/9781555817695

Chapter DOI: 10.1128/9781555817695.ch20

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Abstract:

This chapter enables understanding the three phases of the total testing process; factors affecting quality of test ordering, specimen collection, and patient satisfaction; basic statistical processes involved in monitoring analytical performance; factors affecting test turnaround time; the role of corrected and incomplete reports in quality management and understanding systems for document control. Developing an effective quality management program is challenging because the goal of the program (good outcomes) is often difficult to quantify and may involve processes that are not directly under the laboratory manager's control. Quality management of analytical phase of the testing process is the most standardized and regulated and has therefore received the most attention. Setting up a hot line through which clients can report potential problems or errors and make inquiries may help large laboratories consolidate customer support services. Quality management of the analytical phase involves reducing inaccuracy and imprecision (variability) of test methods as much as possible. The primary quality characteristic that is monitored during the analytical process is the deviation of an analytical measurement from expected. Errors can be classified as systematic (resulting in a shift) or random (resulting in increased imprecision). Inadequate laboratory test turnaround time is one of the most common complaints that comes to the laboratory manager. Clinical laboratories process and handle an enormous amount of information each day. These processes require an organized approach for controlling and organizing this information and making it readily accessible to busy laboratory staff and laboratory inspectors.

Citation: Schifman R, Cembrowski G, Wolk D. 2004. Quality Management, p 369-390. In Garcia L, Baselski V, Burke M, Schwab D, Sewell D, Steele J, Weissfeld A, Wilkinson D, Winn W (ed), Clinical Laboratory Management. ASM Press, Washington, DC. doi: 10.1128/9781555817695.ch20

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Quality Management

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Figure 20.1a

Examples of interlaboratory quality control reports.

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Figure 20.1a

Examples of interlaboratory quality control reports.

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Figure 20.1b

Examples of interlaboratory quality control reports.

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Figure 20.1b

Examples of interlaboratory quality control reports.

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Figure 20.2

Levey-Jennings charts.

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Figure 20.2

Levey-Jennings charts.

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Figure 20.3

Flow chart showing implementation of the 2-2SD / 1-3 SD control procedure. Courtesy Tammy Hofer, BSc (MT), MBA.

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Figure 20.3

Flow chart showing implementation of the 2-2SD / 1-3 SD control procedure. Courtesy Tammy Hofer, BSc (MT), MBA.

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Figure 20.4

Flow chart illustrating proficiency test review.

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Figure 20.4

Flow chart illustrating proficiency test review.

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APPENDIX 20.1a

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APPENDIX 20.1a

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APPENDIX 20.1b

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APPENDIX 20.1b

References

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1. Adcock, D. M.,, D. C. Kressin,, and R. A. Marlar. 1998. Minimum specimen volume requirements for routine coagulation testing-dependence on citrate concentration. Am. J. Clin. Pathol. 109: 595– 599.

2. Bates, D.W.,, L. Goldman,, and T. H. Lee. 1991. Contaminant blood cultures and resource utilization. The true consequences of false-positive results. JAMA 265: 365– 369.

3. Bates, D.W.,, G. J. Kuperman,, E. Rittenberg,, J.M. Teich,, J. Fiskio,, N. Ma’luf,, A. Onderdonk,, D. Wybenga,, J. Winkelman,, T. A. Brennan,, A. L. Komaroff,, and M. Tanasijevic. 1999. A randomized trial of a computer-based intervention to reduce utilization of redundant laboratory tests. Am. J. Med. 106: 144– 150.

4. Becan-McBride, K. 1999. Laboratory sampling. Does the process affect the outcome? J. Intraven. Nurs. 22: 137– 142.

5. Berwick, D. M. 1989. Continuous improvement as an ideal in healthcare. N. Engl. J. Med. 320: 53– 56.

6. Beto, J. A.,, V. K. Bansal,, T. S. Ing,, and J. T. Daugirdas. 1998. Variation in blood sample collection for determination of hemodialysis adequacy. Council on Renal Nutrition National Research Question Collaborative Study Group. Am. J. Kidney Dis. 31: 135– 141.

7. Bonini, P.,, M. Plebani,, F. Ceriotti,, and F. Rubboli. 2002. Errors in laboratory medicine. Clin. Chem. 48: 691– 698.

8. Boyd, J. C.,, and R. A. Felder,. 2003. Preanalytical laboratory automation in the clinical laboratory, p. 107– 130. In K. M. Ward-Cook,, C. A. Lehmann,, L. E. Schoeff,, and R. H. Williams (ed.), Clinical Diagnostic Technology. The Total Testing Process, Vol. 1: The Preanalytical Phase. A.A.C.C. Press, Washington, D.C.

9. Cabana, M. D.,, C. S. Rand,, N. R. Powe,, A.W. Wu,, M. H. Wilson,, P. A. Abboud,, and H. R. Rubin. 1999. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA 282: 1458– 1465.

10. Cembrowski, G. S.,, P. G. Anderson,, and C. A. Crampton. 1996. Pump up your PT IQ. Med. Lab. Obs. 28: 46– 51.

11. Cembrowski, G. S.,, and R. N. Carey,. 1989. Introduction, p. 5. In G. S. Cembrowski (ed.), Laboratory Quality Management: Q.C. Q.A. American Society of Clinical Pathologists, Chicago, Ill.

12. Cembrowski, G. S.,, and P. Champion. 2003. Simple control rules (1-4s or 1-5s) can be used to quality control the Sysmex XE-2100™ Hematology Analyzer. Lab. Hematol. 9: 106– 107.

13. Cembrowski, G. S.,, E. P. Chandler,, and J. Westgard. 1984. Assessment of “average of normals” quality control procedures and guidelines for implementation. Am. J. Clin. Pathol. 81: 492– 499.

14. Cembrowski, G. S.,, J. R. Hackney,, and N. Carey. 1993. The detection of problem analytes in a single proficiency test challenge in the absence of the Health Care Financing Administration rule violations. Arch. Pathol. Lab.Med. 117: 437– 443.

15. Cembrowski, G. S.,, E. S. Lunetzky,, C. C. Patrick,, and M. K. Wilson. 1988. An optimized quality control procedure for hematology analyzers with the use of retained patient specimens. Am. J. Clin. Pathol. 89: 203– 210.

16. Cembrowski, G. S.,, E. Parlapiano,, D. O’Bryan,, and L. Visnapuu. 2001. Successful use of patient moving averages (PMA) as an accuracy control for multichannel hematology analyzers in a high volume robotic clinical laboratory: abstract 3. Lab. Hematol 7: 35.

17. Cembrowski, G. S.,, and J.O. Westgard. 1985. Quality control of multichannel hematology analyzers: evaluation of Bull’s algorithm. Am. J. Clin. Pathol. 83: 337– 345.

18. Chambers, A. M.,, J. Elder,, and D. O’Reilly. 1986. The blunder rate in a clinical biochemistry service. Ann. Clin. Biochem. 23: 470– 473.

19. Connelly, D. P., 2003. Critical pathways, clinical practice guidelines, test selection and ordering, p. 47– 63. In K. M. Ward-Cook,, C. A. Lehmann,, L. E. Schoeff,, and R. H. Williams (ed.), Clinical Diagnostic Technology. The Total Testing Process, Vol. 1: The Preanalytical Phase. A.A.C.C. Press, Washington, D.C.

20. Cotlove, E.,, E. K. Harris,, and G. Z. Williams. 1970. Biological and analytic components of variation in long-term studies of serum consitituents in normal subjects. 3. Physiological and medical implications. Clin. Chem. 16: 1028– 1032.

21. Cunney, R. J.,, E. B. McNamara,, N. Alansari,, B. Loo,, and E. G. Smyth. 1997. The impact of blood culture reporting and clinical liaison on the empiric treatment of bacteraemia. J. Clin. Pathol. 50: 1010– 1012.

22. Dale, J. C.,, and D. A. Novis. 2002. Outpatient phlebotomy success and reasons for specimen rejection. Arch. Pathol. Lab. Med. 126: 416– 419.

23. Donabedian, A., 1992. Defining and measuring the quality of healthcare, p. 41– 64. In R. P. Wenzel (ed.), Assessing Quality Health Care. Williams & Wilkins, Baltimore, Md.

24. Douville, P.,, G. S. Cembrowski,, and J. Strauss. 1987. Evaluation of the average of patients, application to endocrine assays. Clin. Chim. Acta 167: 173– 185.

25. Emancipator, K. 1997. Critical values-ASCP practice parameter. Am. J. Clin. Pathol. 108: 247– 253.

26. Finch, D.,, and C. D. Beaty. 1997. The utility of a single sputum specimen in the diagnosis of tuberculosis-comparison between HIV-infected and non-HIV-infected patients. Chest 111: 1174– 1179.

27. Garcia, F.,, E. Harrison,, C. Wise,, and D. Wolk. 2003. Is your document control out of control? complying with document control regulations. Clin. Leadersh. Manag. Rev. 17: 255– 262.

28. Gibb, A. P.,, B. Hill,, B. Chorel,, and R. Brant. 1997. Reduction in blood culture contamination rate by feedback to phlebotomists. Arch. Pathol. Lab.Med. 121: 503– 507.

29. Hindmarsh, J. T.,, and A.W. Lyon. 1996. Strategies to promote rational clinical chemistry test utilization. Clin. Biochem. 29: 291– 299.

30. Holman, J. W.,, T. E. Mifflin,, R. A. Felder,, and L. M. Demers. 2002. Evaluation of an automated preanalytical robotic workstation at two academic health centers. Clin. Chem. 48: 540– 548.

31. Howanitz, P. J.,, G. S. Cembrowski,, and P. Bachner. 1991. Laboratory phlebotomy: College of American Pathologists Q-Probe study of patient satisfaction and complications in 23,783 patients. Arch. Pathol. Lab.Med. 115: 867– 872.

32. Howanitz, P.J.,, G. S. Cembrowski,, S. J. Steindel,, and T. A. Long. 1993. Physician goals and laboratory test turnaround times: a College of American Pathologists Q-Probes study of 2,763 clinicians and 722 institutions. Arch. Pathol. Lab.Med. 117: 22– 28.

33. Howanitz, P. J.,, and S. J. Steindel. 1993. Digoxin therapeutic drug monitoring practices: a College of American Pathologists Q-Probes study of 666 institutions and 18,679 toxic levels. Arch. Pathol. Lab.Med. 117: 684– 690.

34. Howanitz, P. J.,, S. J. Steindel,, G. S. Cembrowski,, and T. A. Long. 1992. Emergency department stat test turnaround times: a College of American Pathologists’ Q-Probes study for potassium and hemoglobin. Arch. Pathol. Lab.Med. 116: 122– 128.

35. Howanitz, P. J.,, G. A. Tetrault,, and S. J. Steindel. 1997. Clinical laboratory quality control: a costly process now out of control. Clin. Chim. Acta 260: 163– 174.

36. Howanitz, P. J.,, K. Walker,, and P. Bachner. 1992. Quantification of errors in laboratory reports: a quality improvement study of the College of American Pathologists’ Q-Probes program. Arch. Pathol. Lab.Med. 116: 694– 700.

37. Iizuka, Y.,, H. Kume,, and M. Kitamura. 1982. Multivariate delta check method for detecting specimen mix-up. Clin. Chem. 28: 2244– 2248.

38. Irjala, K. M.,, and P. E. Gronross. 1998. Preanalytical and analytical factors affecting laboratory results. Ann.Med. 30: 267– 272.

39. Jones, B. A, R. R. Calam, and P. J. Howanitz. 1997. Chemistry specimen acceptability: a College of American Pathologists Q-Probes study of 453 laboratories. Arch. Pathol. Lab. Med. 121: 19– 26.

40. Jones, B. A.,, F. Meier,, and P. J. Howanitz. 1995. Complete blood count specimen acceptability: a College of American Pathologists Q-Probes study of 703 laboratories. Arch. Pathol. Lab. Med. 119: 203– 208.

41. Keffer, J. H. 2001. Guidelines and algorithms: perception of why and when they are successful and how to improve them. Clin. Chem. 47: 1563– 1572.

42. Kost, G. J. 1990. Critical limits for urgent clinician notification at US medical centers. JAMA 263: 704– 707.

43. Kost, G. J. 1991. Critical limits for emergency clinician notification at United States children’s hospitals. Pediatr. 88: 597– 603.

44. Lacher, D. A. 1990. Relationship between delta checks for selected chemistry tests. Clin. Chem. 36: 2134– 2136.

45. Ladenson, J. H. 1975. Patients as their own controls: use of the computer to identify “laboratory error.” Clin. Chem. 21: 1648– 1653.

46. Lawrence, J. B. 2003. Preanalytical variable in the coagulation laboratory. Lab.Med. 34: 49– 57.

47. Levy, W. C.,, K. L. Hay,, and B. S. Bull. 1986. Preserved blood versus patient data for quality control—Bull’s algorithm revisited. Am. J. Clin. Pathol. 85: 719– 721.

48. Little, J. R.,, P. R. Murray,, P. S. Traynor,, and E. Spitznagel. 1999. A randomized trial of povidone-iodine compared with iodine tincture for venipuncture site disinfection: effects on rates of blood culture contamination. Am. J. Med. 107: 119– 125.

49. Lum, G. 1996. Evaluation of a laboratory critical limit (alert value) policy for hypercalcemia. Arch. Pathol. Lab.Med. 120: 633– 636.

50. Lum, G. 1998. Critical limits (alert values) for physician notification: universal or medical center-specific limits. Ann. Clin. Lab. Sci. 28: 261– 271.

51. Lumadue, J.A.,, J. S. Boyd,, and P. M. Ness. 1997. Adherence to a strict specimen-labeling policy decreases the incidence of erroneous blood grouping of blood bank specimens. Transfusion 37: 1169– 1172.

52. Lundberg, G. D. 1998. The need for an outcomes research agenda for clinical laboratory testing. JAMA 280: 565– 566.

53. Lunetzky, E. S.,, and G. S. Cembrowski. 1987. Performance characteristics of Bull’s multirule algorithm for the quality control of multichannel hematology analyzers. Am. J. Clin. Pathol. 88: 634– 638.

54. Mathur, P.,, L. Sacks,, G. Auten,, R. Sall,, C. Levy,, and F. Gordin. 1994. Delayed diagnosis of pulmonary tuberculosis in city hospitals. Arch. Intern. Med. 154: 306– 310.

55. McQueen, M. J. 2001. Overview of evidence-based medicine: challenges for evidence-based laboratory medicine. Clin. Chem. 47: 1536– 1546.

56. Metzger, L. F.,, W. B. Stauffer,, A. V. Krupinski,, R. P. Millman,, and G. S. Cembrowski. 1987. Detecting errors in blood-gas measurement by analysis with two instruments. Clin. Chem. 33: 512– 517.

57. Miller, J. J., 2003. Specimen collection, handling, preparation and storage, p. 65– 90. In K. M. Ward-Cook,, C. A. Lehmann,, L. E. Schoeff,, and R. H. Williams (ed.), Clinical Diagnostic Technology. The Total Testing Process, Vol. 1: The Preanalytical Phase. A.A.C.C. Press, Washington, D.C.

58. Morgan, M. S. 1995. Perceptions of a medical microbiology service: a survey of laboratory users. J. Clin. Pathol. 48: 915– 918.

59. Morris, A. J.,, P.R. Murray,, and L.B. Reller. 1996. Contemporary testing for enteric pathogens: the potential for cost, time, and health care savings. J. Clin.Microbiol. 34: 1776– 1778.

60. Morris, A. J.,, L.K. Smith,, S. Mirrett,, L. B. Reller. 1996. Cost and time savings following introduction of rejection criteria for clinical specimens. J. Clin.Microbiol. 34: 355– 357.

61. Narajanan, S. 2000. The preanalytic phase: an important component of laboratory medicine. Am. J. Clin. Pathol. 113: 429– 452.

62. Neubauer, A.,, C. Wolter,, C. Falkner,, and D. Neumeier. 1998. Optimizing frequency and number of controls for automatic multichannel analyzers. Clin. Chem. 44: 1014– 1023.

63. Nutting, P. A.,, D. S. Main,, P. M. Fischer,, T. M. Stull,, M. Pontius,, M. Seifert, Jr.,, D. J. Boone,, and S. Holcomb. 1996. Toward optimal laboratory use. Problems in laboratory testing in primary care. JAMA 275: 635– 639.

64. Parvin, C. A.,, and A. M. Gronowski. 1997. Effect of analytical run length on quality-control (QC) performance and the QC planning process. Clin. Chem. 43: 2149– 2154.

65. Peters, M. 1995. Managing test demand by clinicians: computer assisted guidelines. J. Clin. Pathol. 48: 98– 100.

66. Plebania, M.,, and P. Carraro. 1997. Mistakes in a stat laboratory: types and frequency. Clin. Chem. 43: 1348– 1351.

67. Ricos, C.,, V. Alvarez,, F. Cava,, J. V. Garcia-Lario,, A. Hernandez,, C. V. Jimenez,, J. Minchinela,, C. Perich,, M. Simon. 1999. Current databases on biological variation: pros, cons and progress. Scand. J. Clin. Lab. Invest. 60: 491– 500.

68. Schifman, R. B. 1990. Quality assurance goals in clinical pathology. Arch. Pathol. Lab.Med. 114: 1140– 1144.

69. Schifman, R. B.,, P. Bachner,, and P. J. Howanitz. 1996. Blood culture quality improvement: a College of American Pathologists Q-Probes study involving 909 institutions and 289,572 blood culture sets. Arch. Pathol. Lab.Med. 120: 999– 1002.

70. Schifman, R. B.,, P. J. Howanitz,, R. J. Zarbo. 1996. Q-Probes: a College of American Pathologists benchmarking program for quality management in pathology and laboratory medicine. Adv. Pathol. 9: 83– 120.

71. Schifman, R. B.,, A. Pindur,, and J. A. Bryan. 1997. Laboratory practices for reporting bacterial susceptibility tests that affect antibiotic therapy. Arch. Pathol. Lab.Med. 121: 1168– 1170.

72. Schifman, R. B.,, C. Strand,, F. Meier,, and P. Howanitz. 1998. Blood culture contamination: a College of American Pathologists Q-Probes study involving 640 institutions and 497,134 specimens from adult patients. Arch. Pathol. Lab.Med. 122: 216– 221.

73. Schumacher, G. E, and J. T. Barr. 1998. Total testing process applied to therapeutic drug monitoring: impact on patients’ outcomes and economics. Clin. Chem. 44: 370– 374.

74. Shahangian, S.,, R. Cohn,, E. E. Gaunt,, and J. M. Krolak. 1999. System to monitor a portion of the total testing process in medical clinics and laboratories: evaluation of a split-specimen design. Clin. Chem. 45: 269– 280.

75. Sheiner, L. B.,, L. A. Wheeler,, and J. K. Moore. 1979. The performance of delta check methods. Clin. Chem. 25(12): 2034– 2037.

76. Simpson, J. B. 2001. A unique approach for reducing specimen labeling errors: combining marketing techniques with performance improvement. Clin. Leadersh.Manage. Rev. 15: 401– 405.

77. Smith, B. J.,, and M. D. McNeely. 1999. The influence of an expert system for test ordering and interpretation on laboratory investigations. Clin. Chem. 45: 1168– 1175.

78. Stahl, M.,, E. D. Lund,, and I. Brrandslund. 1998. Reasons for a laboratory’s inability to report results for requested analytical tests. Clin. Chem. 44: 2195– 2197.

79. Steindel, S. J.,, and P. J. Howanitz. 2001. Physician satisfaction and emergency department laboratory test turnaround time. Arch. Pathol. Lab.Med. 125: 863– 871.

80. Steindel, S. J.,, and D. A. Novis. 1999. Using outlier events to monitor test turnaround time—a College of American Pathologists Q-Probes study in 496 laboratories. Arch. Pathol. Lab.Med. 123: 607– 614.

81. Studnicki, J.,, D.D. Bradham,, J. Marshburn,, P. R. Foulis,, and J.V. Straumfjord. 1993. A feedback system for reducing excessive laboratory tests. Arch. Pathol. Lab.Med. 117: 35– 39.

82. Tierney, W. M.,, M. E. Miller,, J. M. Overhage,, and C. J. McDonald. 1993. Physician inpatient order writing on microcomputer workstations. Effects on resource utilization. JAMA 269: 379– 383.

83. Tilzer, L. L.,, and R. W. Jones. 1988. Use of barcode labels on collection tubes for specimen management in the clinical laboratory. Arch. Pathol. Lab.Med. 112: 1200– 1202.

84. Tonks, D.B. 1963. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin. Chem. 9: 217– 223.

85. U.S. Department of Health and Human Services. 1992. Medicare, Medicaid, and CLIA programs. Regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rule. Fed. Regis. 57: 7002.

86. Valenstein, P. 1996. Laboratory turnaround time. Am. J. Clin. Pathol. 105: 676– 688.

87. Valenstein, P.,, and P. J. Howanitz. 1995. Ordering accuracy: a College of American Pathologists Q-Probes study of 577 institutions. Arch. Pathol. Lab.Med. 119: 117– 122.

88. Valenstein, P.,, and F. Meier. 1999. Outpatient order accuracy— a College of American Pathologists Q-Probes study of requisition order entry accuracy in 660 institutions. Arch. Pathol. Lab. Med. 123: 1145– 1150.

89. Weinbaum, F. I.,, S. Lavie,, M. Danek,, D. Sixsmith,, G. F. Heinrich,, and S. S. Mills. 1997. Doing it right the first time: quality improvement and the contaminant blood culture. J. Clin.Microbiol. 35: 563– 565.

90. Westgard, J.O.,, and T. Groth. 1979. Power functions for statistical control rules. Clin. Chem. 25: 863– 869.

91. Westgard, J. O.,, T. Groth,, T. Aronsson,, H. Falk,, and C. H. de Verdier. 1977. Performance characteristics of rules for internal quality control: probabilities for false rejection and error detection. Clin. Chem. 23: 1857– 1867.

92. Westgard, J.O.,, B. Stein,, S. A. Westgard,, and R. Kennedy. 1997. QC Validator 2.0: a computer program for automatic selection of statistical QC procedures for applications in healthcare laboratories. Comput.Methods Programs Biomed. 53: 175– 186.

93. Wheeler, L. A.,, and L. B. Sheiner. 1981. A clinical evaluation of various delta check methods. Clin. Chem. 127: 5– 9.

94. Wilson, M. L. 1996. General principles of specimen collection and transport. Clin. Infect. Dis. 22: 766– 777.

95. Witte, D. L.,, S. A. VanNess,, D. S. Angstadt,, and B. J. Pennell. 1997. Errors, mistakes, blunders, outliers, or unacceptable results: how many? Clin. Chem. 43: 1352– 1356.

96. Zarbo, R. J.,, B. A. Jones,, R. C. Friedberg,, P. N. Valenstein,, S.W. Renner,, R. B. Schifman,, M. K. Walsh,, and P. J. Howanitz. 2002. Q-Tracks: a College of American Pathologists program of continuous laboratory monitoring and longitudinal tracking. Arch. Pathol. Lab.Med. 126: 1036– 1044.

Tables

Quality Management

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Table 20.1

CAP Q-Tracks and Q-Probes quality assurance program, 2004 a

a CAP (http://www.cap.org).

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Table 20.1

CAP Q-Tracks and Q-Probes quality assurance program, 2004 a

a CAP (http://www.cap.org).

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Table 20.2

Method evaluation and implementation

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Table 20.2

Method evaluation and implementation

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Table 20.3

Quality control rules

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Table 20.3

Quality control rules

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Table 20.4

Comparison of MAEs, derived from physiological variation to typical instrument imprecisions

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Table 20.4

Comparison of MAEs, derived from physiological variation to typical instrument imprecisions

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Table 20.5a

CLIA testing criteria for acceptable external proficiency testing performance

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Table 20.5a

CLIA testing criteria for acceptable external proficiency testing performance

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Table 20.5b

CLIA testing criteria for acceptable external proficiency testing performance

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Table 20.5b

CLIA testing criteria for acceptable external proficiency testing performance

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Table 20.6

Stages in the testing cycle where turnaround time may be measured

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Table 20.6

Stages in the testing cycle where turnaround time may be measured

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Table 20.7

Document categories

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Table 20.7

Document categories