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Chapter 21 : Quality Management

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Abstract:

The “total testing process” is a concept that provides a comprehensive working model for evaluating the components of the laboratory’s quality management plan as an interdependent component of the organization’s total quality improvement program. This chapter explains the three phases of the total testing process. The first phase, the preanalytical phase, involves all the various processes and resources that precede the measuring step. The second phase, the analytical phase, involves managing the reliability of instruments and reagents used for measuring patient specimens and obtaining test results. The last phase, postanalytical, involves reporting, interpretation, and clinical use of test results. The chapter discusses the factors affecting quality of test ordering, specimen collection, and patient satisfaction. Special attention must be given to the collection of specimens for microbiological examinations. In some cases, specimen quality can be evaluated by smear examinations before cultures are performed, and specimens may be deferred from testing if judged to be of poor quality. The only direct experience patients have with the laboratory is during phlebotomy. Patient satisfaction with this experience is an important preanalytical quality measurement. The chapter talks about basic statistical processes involved in monitoring analytical performance. Factors affecting test turnaround time are explained. The chapter also discusses the role of corrected and incomplete reports in quality management, and systems for document control. A document control policy should state the intent and direction the laboratory takes to document and record the structure it uses for creating, revising, approving, distributing, storing, retrieving, and destroying documents.

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Figure 21.1a

Examples of interlaboratory quality control reports. (A) The SDI (a peer-based measure of bias) and CVR (a peer-based estimator of precision) are combined as an , coordinate within three performance zones: acceptable, acceptable to marginal, and marginal. (B) Reports provide monthly and cumulative statistics for the laboratory and between-laboratory comparisons with a peer group. Report includes mean, standard deviation, coefficient of variation, CVR, SDI, number of data points, and number of laboratories. CVR, coefficient of variation ratio, a ratio of laboratory imprecision to peer group imprecision. A value less than 1 indicates better than average imprecision; a value greater than 1 indicates more than average imprecision compared to the peer group. doi:10.1128/9781555817282.ch21.f1a

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.1b
Figure 21.1b

Examples of interlaboratory quality control reports. (A) The SDI (a peer-based measure of bias) and CVR (a peer-based estimator of precision) are combined as an , coordinate within three performance zones: acceptable, acceptable to marginal, and marginal. (B) Reports provide monthly and cumulative statistics for the laboratory and between-laboratory comparisons with a peer group. Report includes mean, standard deviation, coefficient of variation, CVR, SDI, number of data points, and number of laboratories. CVR, coefficient of variation ratio, a ratio of laboratory imprecision to peer group imprecision. A value less than 1 indicates better than average imprecision; a value greater than 1 indicates more than average imprecision compared to the peer group. doi:10.1128/9781555817282.ch21.f1b

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.2
Figure 21.2

Quality control charts. doi:10.1128/9781555817282.ch21.f2

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.3
Figure 21.3

Flow chart showing implementation of the 2-2SD/1-3SD control procedure. Courtesy of Tammy Hofer. doi:10.1128/9781555817282.ch21.f3

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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Image of Figure 21.4
Figure 21.4

Flow chart illustrating proficiency test review, from reference with permission. doi:10.1128/9781555817282.ch21.f4

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
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References

/content/book/10.1128/9781555817282.chap21
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. [PubMed]
2. Aichinger, E.,, C. D. Schleck,, W. S. Harmsen,, L. M. Nyre,, and R. Patel. 2008. Nonutility of repeat laboratory testing for detection of Clostridium difficile by use of PCR or enzyme immunoassay. J. Clin Microbiol. 46: 3795 3797. [PubMed][CrossRef]
3. 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. [PubMed]
4. 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. [PubMed]
5. Bauer, K. A.,, J. E. West,, J. M. Balada-Llasat,, P. Pancholi,, K. B. Stevenson,, and D. A. Goff. An antimicrobial stewardship program's impact with rapid polymerase chain reaction methicillin-resistant Staphylococcus aureus/S. aureus blood culture test in patients with S. aureus bacteremia. Clin. Infect. Dis. 51( 9): 1074 1080. [PubMed][CrossRef]
6. Becan-McBride, K. 1999. Laboratory sampling. Does the process affect the outcome? J. Intraven. Nurs. 22: 137 142. [PubMed]
7. Berwick, D. M. 1989. Continuous improvement as an ideal in healthcare. N. Engl. J. Med. 320: 53 56.
8. 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. [PubMed]
9. Bonini, P.,, M. Plebani,, F. Ceriotti,, and F. Rubboli. 2002. Errors in laboratory medicine. Clin. Chem. 48: 691 698.
10. 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, DC.
11. 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. [PubMed]
12. Carey, R. N.,, G. S. Cembrowski,, C. C. Garber,, and Z. Zaki. 2005. Performance characteristics of several rules for self-interpretation of proficiency testing data. Arch. Pathol. Lab. Med. 129( 8): 997 1003. [PubMed][CrossRef]
13. Cembrowski, G. S. 1997. Thoughts on quality-control systems: a laboratorian's perspective. Clin. Chem. 43( 5): 886 892. [PubMed]
14. Cembrowski, G. S., 2012. Hematology quality practices, p. 686 706. In s K. Kottke-Marchand, and B. H. Davis (ed.), Laboratory Hematology Practice. Wiley-Blackwell, Chichester, United Kingdom.
15. Cembrowski, G. S.,, P. G. Anderson,, and C. A. Crampton. 1996. Pump up your PT IQ. Med. Lab. Obs. 28: 46 51. [PubMed]
16. 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, IL.
17. 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. [PubMed]
18. 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. [PubMed]
19. 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. [PubMed]
20. 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.
21. Cembrowski, G. S.,, B. Smith,, and D. Tung. 2010. Rationale for using insensitive quality control rules for today's hematology analyzers. Int. J. Lab. Hematol. 32( 6 Pt 2): 606 615. [PubMed][CrossRef]
22. Cembrowski, G. S.,, S. Strauss,, E. J. Waldeland,, E. Kropp,, and S. A. Adlis,. 1996. Are phlebotomy services completely satisfying our patient customers?, p. 198 208. In J. M. s Krolak,, A. O'Connor, and P. Thompson (ed.), 1995 Institute on Critical Issues in Health Laboratory Practice: Frontiers in Laboratory Practice Research, Institute Proceedings, CDC, s Atlanta, GA.
23. 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. [PubMed]
24. Chambers, A. M.,, J. Elder,, and D. O'Reilly. 1986. The blunder rate in a clinical biochemistry service. Ann. Clin. Biochem. 23: 470 473. [PubMed]
25. Christenson, R. H.,, and S. H. Duh. 2012. Methodological and analytic considerations for blood biomarkers. Prog. Cardiovasc. Dis. 55: 25 33. [PubMed][CrossRef]
26. Clinical and Laboratory Standards Institute (CLSI). 2011. Quality Management System: A Model for Laboratory Services; Approved Guideliness, 4th ed. Document GP 26-A. CLSI, Wayne, PA.
27. 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, DC.
28. Coppens, A.,, M. Speeckaert,, and J. Delanghe. 2011. The pre–analytical challenges of routine urinalysis. Acta Clin. Belg. 65: 182 189. [PubMed]
29. Cotlove, E.,, E. K. Harris,, and G. Z. Williams. 1970. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. 3. Physiological and medical implications. Clin. Chem. 16: 1028 1032. [PubMed]
30. 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. [PubMed]
31. Dale, J. C.,, and D. A. Novis. 2002. Outpatient phlebotomy success and reasons for specimen rejection. Arch. Pathol. Lab. Med. 126: 416 419. [PubMed][CrossRef]
32. 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.
33. 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. [PubMed]
34. Ehrmeyer, S. S. 2013. Satisfying regulatory and accreditation requirements for quality control. Clin. Lab. Med. 33: 27 40. [PubMed][CrossRef]
35. Emancipator, K. 1997. Critical values: ASCP practice parameter. Am. J. Clin. Pathol. 108: 247 253. [PubMed]
36. Erasmus, R. T.,, and A. E. Zemlin. 2009. Clinical audit in the laboratory. J. Clin. Pathol. 62: 593 597.
37. 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. [PubMed]
38. Forrest, G. N.,, K. Mankes,, M. A. Jabra-Rizk,, E. Weekes,, J. K. Johnson,, D. P. Lincalis,, and R. A. Venezia. 2006. Peptide nucleic acid fluorescence in situ hybridization-based identification of Candida albicans and its impact on mortality and antifungal therapy costs. J. Clin. Microbiol. 44( 9): 3381 3383. [PubMed][CrossRef]
39. Forrest, G. N.,, S. Mehta,, E. Weekes,, D. P. Lincalis,, J. K. Johnson,, and R. A. Venezia. 2006. Impact of rapid in situ hybridization testing on coagulase-negative staphylococci positive blood cultures. J. Antimicrob. Chemother. 58( 1): 154 158. [PubMed][CrossRef]
40. Forrest, G. N.,, M. C. Roghmann,, L. S. Toombs,, J. K. Johnson,, E. Weekes,, D. P. Lincalis,, and R. A. Venezia. 2008. Peptide nucleic acid fluorescent in situ hybridization for hospital-acquired enterococcal bacteremia: delivering earlier effective antimicrobial therapy. Antimicrob. Agents Chemother. 52( 10): 3558 3563 [PubMed][CrossRef]
41. 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. [PubMed]
42. 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. [PubMed]
43. Hawkins, R. 2012. Managing the pre- and post-analytical phases of the total testing process. Ann. Lab. Med. 32: 5 16. [PubMed][CrossRef]
44. Hindmarsh, J. T.,, and A. W. Lyon. 1996. Strategies to promote rational clinical chemistry test utilization. Clin. Biochem. 29: 291 299. [PubMed]
45. Ho, A.,, L. Purdy,, B. Adrian, et al. 2002. Measurement of variation in videotaped outpatient phlebotomies. Lab. Med. 33: 179 185.
46. 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. [PubMed]
47. 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. [PubMed]
48. 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. [PubMed]
49. 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. [PubMed]
50. 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. [PubMed]
51. 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. [PubMed]
52. 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. [PubMed]
53. Iizuka, Y.,, H. Kume,, and M. Kitamura. 1982. Multivariate delta check method for detecting specimen mix-up. Clin. Chem. 28: 2244 2248. [PubMed]
54. Irjala, K. M.,, and P. E. Gronross. 1998. Preanalytical and analytical factors affecting laboratory results. Ann. Med. 30: 267 272. [PubMed]
55. Jones, B. A.,, L. G. Bekeris,, R. E. Nakhleh,, M. K. Walsh,, and P. N. Valenstein. 2009. Physician satisfaction with clinical laboratory services: a College of American Pathologists Q-probes study of 138 institutions. Arch. Pathol. Lab. Med. 133( 1): 38 43. [PubMed][CrossRef]
56. 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. [PubMed]
57. 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. [PubMed]
58. Jones, B. A.,, M. K. Walsh,, and S. G. Ruby. 2006. Hospital nursing satisfaction with clinical laboratory services: a College of American Pathologists Q-Probes study of 162 institutions. Arch. Pathol. Lab. Med. 130( 12): 1756 1761. [PubMed][CrossRef]
59. 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. [PubMed]
60. Kost, G. J. 1990. Critical limits for urgent clinician notification at US medical centers. JAMA 263: 704 707. [PubMed]
61. Kost, G. J. 1991. Critical limits for emergency clinician notification at United States children's hospitals. Pediatr. 88: 597 603. [PubMed]
62. Lacher, D. A. 1990. Relationship between delta checks for selected chemistry tests. Clin. Chem. 36: 2134 2136. [PubMed]
63. Ladenson, J. H. 1975. Patients as their own controls: use of the computer to identify “laboratory error.” Clin. Chem. 21: 1648 1653. [PubMed]
64. Lawrence, J. B. 2003. Preanalytical variable in the coagulation laboratory. Lab. Med. 34: 49 57.
65. 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. [PubMed]
66. Liang, S.,- L. M.-T. Lin,, M. J. Hafez,, C. D. Gocke,, K. M. Murphy,, L. J. Sokoll,, and J. R. Eshleman. 2008. Application of traditional clinical pathology quality control techniques to molecular pathology. J. Mol. Diagn. 10( 2): 142 146. [PubMed][CrossRef]
67. Lillo, R.,, M. Salinas,, M. Lopez-Garrigos,, Y. Naranio-Santana,, M. Gutierrez,, M. D. Marin,, M. Miralles,, and J. Uris. 2012. Reducing preanalytical laboratory sample errors through educational and technological interventions. Clin. Lab. 58: 911 917. [PubMed]
68. Lippi, G.,, K. Becan–McBride,, D. Behúlová,, R. A. Bowen,, S. Church,, J. Delanghe,, K. Grankvist,, S. Kitchen,, M. Nybo,, M. Nauck,, N. Nikolac,, V. Palicka,, M. Plebani,, S. Sandberg,, and A. M. Simundic. 2013. Preanalytical quality improvement: in quality we trust. Clin. Chem. Lab. Med. 51: 229 241. [PubMed][CrossRef]
69. 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. [PubMed]
70. Lum, G. 1996. Evaluation of a laboratory critical limit (alert value) policy for hypercalcemia. Arch. Pathol. Lab. Med. 120: 633 636. [PubMed]
71. Lum, G. 1998. Critical limits (alert values) for physician notification: universal or medical center-specific limits. Ann. Clin. Lab. Sci. 28: 261 271. [PubMed]
72. 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. [PubMed]
73. Lundberg, G. D. 1998. The need for an outcomes research agenda for clinical laboratory testing. JAMA 280: 565 566. [PubMed]
74. 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. [PubMed]
75. Lyon, A. W.,, T. Higgins,, J. C. Wesenberg,, D. V. Tran,, and G. S. Cembrowski. 2009. Variation in the frequency of hemoglobin A1c (HbA1c) testing: population studies used to assess compliance with clinical practice guidelines and use of HbA1c to screen for diabetes. J. Diabetes Sci. Technol. 1;3( 3): 411 417. [PubMed]
76. 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. [PubMed]
77. McCormick, D.,, D. H. Bor,, S. Woolhandler,, and D. U. Himmelstein. 2012. Providing office-based physicians electronic access to patients' prior imaging and lab results did not deter ordering of tests. Health Aff. 31( 3): 488 496. http://www.ncbi.nlm.nih.gov/pubmed/22392659>http://www.ncbi.nlm.nih.gov/pubmed/22392659. [PubMed][CrossRef]
78. McQueen, M. J. 2001. Overview of evidence-based medicine: challenges for evidence-based laboratory medicine. Clin. Chem. 47: 1536 1546. [PubMed]
79. 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. [PubMed]
80. 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, DC.
81. Morgan, M. S. 1995. Perceptions of a medical microbiology service: a survey of laboratory users. J. Clin. Pathol. 48: 915 918. [PubMed]
82. 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. [PubMed]
83. Morris, A. J.,, L. K. Smith,, S. Mirrett,, and L. B. Reller. 1996. Cost and time savings following introduction of rejection criteria for clinical specimens. J. Clin. Microbiol. 34: 355 357. [PubMed]
84. Narajanan, S. 2000. The preanalytic phase: an important component of laboratory medicine. Am. J. Clin. Pathol. 113: 429 452. [PubMed][CrossRef]
85. 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. [PubMed]
86. Novis, D. A.,, M. K. Walsh,, J. C. Dale,, P. J. Howanitz, and College of American Pathologists Q-Tracks. 2004. Continuous monitoring of stat and routine outlier turnaround times: two College of American Pathologists Q-Tracks monitors in 291 hospitals. Arch. Pathol. Lab. Med. 128( 6): 621 626. [PubMed][CrossRef]
87. 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. [PubMed]
88. Ovens, K.,, and C. Naugler. 2012. How useful are delta checks in the 21 century? A stochastic-dynamic model of specimen mix-up and detection. J. Pathol. Inform. 3: 5. [PubMed][CrossRef]
89. Pai, M.,, K. A. Moffat,, E. Plumhoff,, and C. P. Hayward. 2011. Critical values in the coagulation laboratory: results of a survey of the North American Specialized Coagulation Laboratory Association. Am. J. Clin. Pathol. 136( 6): 836 841. [PubMed][CrossRef]
90. 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. [PubMed]
91. Peters, M. 1995. Managing test demand by clinicians: computer assisted guidelines. J. Clin. Pathol. 48: 98 100. [PubMed]
92. Plebani, M. 2010. The detection and prevention of errors in laboratory medicine. Ann. Clin. Biochem. 47: 101 110. [PubMed][CrossRef]
93. Plebani, M.,, and P. Carraro. 1997. Mistakes in a stat laboratory: types and frequency. Clin. Chem. 43: 1348 1351. [PubMed]
94. Plebani, M.,, E. J. Favaloro,, and G. Lippi. 2012. Patient safety and quality in laboratory and hemostasis testing: a renewed loop? Semin. Thromb. Hemost. 38: 553 558. [PubMed][CrossRef]
95. Ravine, D.,, and G. Suthers. 2012. Quality standards and samples in genetic testing. J. Clin. Pathol. 65: 389 393. [PubMed][CrossRef]
96. Ricos, C.,, V. Alvarez,, F. Cava,, J. V. Garcia-Lario,, A. Hernandez,, C. V. Jimenez,, J. Minchinela,, C. Perich,, and M. Simon. 1999. Current databases on biological variation: pros, cons and progress. Scand. J. Clin. Lab. Invest. 60: 491 500.
97. Schiff, G. D.,, S. Kim,, N. Krosnjar,, M. F. Wisniewski,, J. Bult,, L. Fogelfeld,, and R. A. McNutt. 2005. Missed hypothyroidism diagnosis uncovered by linking laboratory and pharmacy data. Arch. Intern. Med. 14; 165( 5): 574 577. [PubMed][CrossRef]
98. Schifman, R. B. 1990. Quality assurance goals in clinical pathology. Arch. Pathol. Lab. Med. 114: 1140 1144.
99. 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. [PubMed]
100. Schifman, R. B.,, P. J. Howanitz,, and 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.
101. 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. [PubMed]
102. 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. [PubMed]
103. 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. [PubMed]
104. 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. [PubMed]
105. 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. [PubMed]
106. 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. [PubMed]
107. Snyder, S. R.,, A. M. Favoretto,, R. A. Baetz,, J. H. Derzon,, B. M. Madison,, D. Mass,, C. S. Shaw,, C. D. Layfield,, R. H. Christenson,, and E. B. Liebow. 2012. Effectiveness of practices to reduce blood culture contamination: A Laboratory Medicine Best Practices systematic review and meta-analysis. Clin. Biochem. Epub ahead of print, PubMed PMID: 22709932.
108. Solomon, D. H.,, H. Hashimoto,, L. Daltroy,, and M. H. Liang. 1998. Techniques to improve physicians' use of diagnostic tests: a new conceptual framework. JAMA 280( 23): 2020 2027. [PubMed]
109. Sonntag, O. 2009. Analytical interferences and analytical quality. Clin. Chim. Acta 404: 37 40.
110. Stahl, M.,, E. D. Lund,, and I. Brandslund. 1998. Reasons for a laboratory's inability to report results for requested analytical tests. Clin. Chem. 44: 2195 2197. [PubMed]
111. Steindel, S. J.,, and P. J. Howanitz. 2001. Physician satisfaction and emergency department laboratory test turnaround time. Arch. Pathol. Lab. Med. 125: 863 871. [PubMed][CrossRef]
112. 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. [PubMed][CrossRef]
113. Straseski, J. A.,, and F. G. Strathmann. 2013. Patient data algorithms. Clin. Lab. Med. 33: 147 160.
114. Strathmann, F. G.,, G. S. Baird,, and N. G. Hoffman. 2011. Simulations of delta check rule performance to detect specimen mislabeling using historical laboratory data. Clin. Chim. Acta. 412( 21-22): 1973 1977. [PubMed][CrossRef]
115. Strathmann, F. G.,, M. M. Ka,, P. M. Rainey,, and G. S. Baird. 2011. Use of the BD vacutainer rapid serum tube reduces false-positive results for selected Beckman Coulter UnicelDxI immunoassays. Am. J. Clin. Pathol. 136( 2): 325 329. [PubMed][CrossRef]
116. Streichert, T.,, B. Otto,, C. Schnabel,, G. Nordholt,, M. Haddad,, M. Maric,, A. Petersmann,, R. Jung,, and C. Wagener. 2011. Determination of hemolysis thresholds by the use of data loggers in pneumatic tube systems. Clin. Chem. 57: 1390 1397. [PubMed][CrossRef]
117. 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. [PubMed]
118. 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. [PubMed]
119. 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. [PubMed]
120. Tomlin, A.,, S. Dovey,, R. Gauld,, and M. Tilyard. 2011. Better use of primary care laboratory services following interventions to “market” clinical guidelines in New Zealand: a controlled before-and- after study. BMJ Qual. Saf. 20( 3): 282 290. [PubMed][CrossRef]
121. Tonks, D. B. 1963. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin. Chem. 9: 217 223.
122. 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. Regist. 57: 7002.
123. Valenstein, P. 1996. Laboratory turnaround time. Am. J. Clin. Pathol. 105: 676 688.
124. 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. [PubMed]
125. 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. [PubMed][CrossRef]
126. Valenstein, P. N.,, S. S. Raab,, and M. K. Walsh. 2006. Identification errors involving clinical laboratories: a College of American Pathologists Q-Probes study of patient and specimen identification errors at 120 institutions. Arch. Pathol. Lab. Med. 130( 8): 1106 1113. [PubMed][CrossRef]
127. Vesper, H. W.,, and L. M. Thienpont. 2009. Traceability in laboratory medicine. Clin. Chem. 55: 1067 1075. [PubMed][CrossRef]
128. Wagar, E. A.,, R. C. Friedberg,, R. Souers,, and A. K. Stankovic. 2007. Critical values comparison: a College of American Pathologists Q-Probes survey of 163 clinical laboratories. Arch. Pathol. Lab. Med. 131( 12): 1769 1775. [PubMed][CrossRef]
129. Walz, S. E.,, and T. P. Darcy. 2013. Patient safety and post-analytical error. Clin. Lab. Med. 33: 183 194. [PubMed][CrossRef]
130. 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. [PubMed]
131. Westgard, J. O.,, and T. Groth. 1979. Power functions for statistical control rules. Clin. Chem. 25: 863 869. [PubMed]
132. 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. [PubMed]
133. Wheeler, L. A.,, and L. B. Sheiner. 1981. A clinical evaluation of various delta check methods. Clin. Chem. 127: 5 9.
134. Wilson, M. L. 1996. General principles of specimen collection and transport. Clin. Infect. Dis. 22: 766 777. [PubMed]
135. 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. [PubMed]
136. Wolk, D. M.,, E. J. Kaleta,, and V. H. Wysocki. 2012. PCRelectrospray ionization mass spectrometry: the potential to change infectious disease diagnostics in clinical and public health laboratories. J. Mol. Diagn. 14( 4): 295 304. [PubMed][CrossRef]
137. World Health Organization. 2002. Use of anticoagulants in diagnostic laboratory investigations and stability of blood, plasma and serum samples, WHO/DIL/LAB/99.1 Rev.2. http://whqlibdoc.who.int/hq/2002/WHO_DIL_LAB_99.1_Rev.2.pdf.
138. 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. [PubMed][CrossRef]

Tables

Generic image for table
Table 21.1

CAP Q-Tracks and Q-Probes quality assurance program, 2011

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

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.2

Method evaluation and implementation

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.3

Common quality control rules

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.4

Comparison of MAEs derived from physiological variation to typical instrument imprecisions

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.5

Control rules that can be used for various MAE/imprecision ratios

Adapted with permission from reference .

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.6a

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.6b

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.6c

CLIA testing criteria for acceptable external proficiency testing performance

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.7

Stages in the testing cycle where turnaround time may be measured

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21
Generic image for table
Table 21.8

CLSI quality system essentials

See reference .

Citation: Schifman R, Cembrowski G, Wolk D, Brisbois J. 2014. Quality Management, p 421-446. In Garcia L (ed), Clinical Laboratory Management, Second Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817282.ch21

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