Performance criteria of the post-analytical phase

Clinical Chemistry and Laboratory Medicine

Volumn 53, Issue 6, 2015, Pages 949-958

  Sikaris, Kenneth ^a  

^a MELBOURNE PATHOLOGY   (Australia)

Author keywords

clinical decision support; clinical outcome; post analytical; quality; reference interval

Indexed keywords

CHOLESTEROL; HEMOGLOBIN A1C; PROSTATE SPECIFIC ANTIGEN;

ANALYTICAL ERROR; CARDIOVASCULAR RISK; CLINICAL CHEMISTRY; CLINICAL DECISION MAKING; CONFERENCE PAPER; CONSENSUS; DECISION SUPPORT SYSTEM; FOLLOW UP; HEALTH CARE MANAGEMENT; HEALTH CARE QUALITY; HISTOPATHOLOGY; HUMAN; IMPAIRED GLUCOSE TOLERANCE; INDIVIDUALITY; LIMIT OF DETECTION; OUTCOME ASSESSMENT; PERFORMANCE; PERFORMANCE CRITERIA; PREGNANCY DIABETES MELLITUS; PREGNANCY TEST; PRIORITY JOURNAL; PROFESSIONAL KNOWLEDGE; PROSTATE CANCER; PROSTATE HYPERTROPHY; PROSTATITIS; PROTEIN ELECTROPHORESIS; QUALITY CONTROL; QUANTITATIVE ANALYSIS; REFERENCE VALUE; STANDARD; TURNAROUND TIME; DIAGNOSTIC PROCEDURE; GOOD LABORATORY PRACTICE; RISK; STANDARDS;

CLINICAL LABORATORY TECHNIQUES; HUMANS; LABORATORY PROFICIENCY TESTING; QUALITY ASSURANCE, HEALTH CARE; REFERENCE VALUES; RISK;

EID: 84929094004     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/cclm-2015-0016     Document Type: Conference Paper

References (103)

1. Fraser CG. Biological variation: from principles to practice. Washington: AACC Press, 2001.
2. Cotlove E, Harris EK, Williams GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. III. Physiological and medical implications. Clin Chem 1970;16:1028-32.
3. ISO 15189:2012. Medical laboratories-requirements for quality and competence. Geneva, Switzerland: International Organization for Standardization, 2012.
4. ISO 17043:2010 Conformity assessment-general requirements for proficiency testing. Geneva, Switzerland: International Organization for Standardization, 2010.
5. Likert R. A technique for the measurement of attitudes. Arch Psychol 1932;140:1-55.
6. Rosenkrantz AB, Lim RP, Haghighi M, Somberg MB, Babb JS, Taneja SS. Comparison of inter-reader reproducibility of the prostate imaging reporting and data system and Likert scales for evaluation of multiparametric prostate MRI. AJR Am J Roent-genol 2013;201:W612-8.
7. Cooper JA, Ryan C, Smith SM, Wallace E, Bennett K, Cahir C, et al. The development of the PROMPT (PRescribing Optimally in Middle-aged People's Treatments) criteria. BMC Health Serv Res 2014;14:484.
8. Plebani M. Total quality in laboratory medicine: the case of haematology and coagulation testing. Int Jnl Lab Hem 2007;29(Suppl 1):36.
9. Cunney R, Aziz HA, Schubert D, McNamara E, Smyth E. Interpretative reporting and selective antimicrobial susceptibility release in non-critical microbiology results. J Antimicrob Chem-other 2000;45:705-8.
10. Walley T. Evaluating laboratory diagnostic tests. BMJ 2008;336:569-70.
11. Kilpatrick ES, Freedman DB. National clinical biochemistry audit group. A national survey of interpretative reporting in the UK. Ann Clin Biochem 2011;48:317-20.
12. Barlow IM. Are biochemistry interpretative comments helpful? Results of a general practitioner and nurse practitioner survey. Ann Clin Biochem 2008;45:88-90.
13. Kilpatrick ES. Can the addition of interpretative comments to laboratory reports influence outcome? An example involving patients taking thyroxine. Ann Clin Biochem 2004;41:227-9.
14. Vasikaran SD, Penberthy L, Gill J, Scott S, Sikaris KA. Review of a pilot quality-assessment program for interpretative comments. Ann Clin Biochem 2002;39:250-60.
15. Lim EM, Vasikaran SD, Gill J, Calleja J, Hickman PE, Beilby J, et al. A discussion of cases in the 2001 RCPA-AQAP chemical pathology case report comments program. Pathology 2003;35:145-50.
16. Lim EM, Sikaris KA, Gill J, Calleja J, Hickman PE, Beilby J, et al. Quality assessment of interpretative commenting in clinical chemistry. Clin Chem 2004;50:632-7.
17. Vasikaran SD. Anatomy and history of an external quality assessment program for interpretative comments in clinical biochemistry. Clin Biochem 2014 Dec 24.doi: 10.1016/j.clinbio-chem.2014.12.014. [Epub ahead of print].
18. Li P, Challand GS. Experience with assessing the quality of comments on clinical biochemistry reports. Ann Clin Biochem 1999;36:759-65.
19. Laposata M. Patient-specific narrative interpretations of complex clinical laboratory evaluations: who is competent to provide them? Clin Chem 2004;50:471-2.
20. Vasikaran SD, Lai LC, Sethi S, Lopez JB, Sikaris KA. Quality of interpretative commenting on common clinical chemistry results in the Asia-Pacific region and Africa. Clin Chem Lab Med 2009;47:963-70.
21. Marshall WJ, Challand GS. Provision of interpretative comments on biochemical report forms. Ann Clin Biochem 2000;37:758-63.
22. Challand GS, Vasikaran SD. The assessment of interpretation in clinical biochemistry: a personal view. Ann Clin Biochem 2007;44:101-5.
23. Vasikaran S. Interpretative commenting. Clin Biochem Rev 2008;29(Suppl 1):S99-103.
24. Paterson JR, Paterson R. Reflective testing: how useful is the practice of adding on tests by laboratory physicians. J Clin Pathol 2004;57:272-5.
25. Jones BJ, Twomey PJ. Comparison of reflective and reflex testing for hypomagnesaemia in severe hypokalaemia. J Clin Pathol 2009;62:816-9.
26. Srivastava R, Bartlett WA, Kennedy IM, Hiney A, Fletcher C, Murphy MJ. Reflex and reflective testing: efficiency and effectiveness of adding on laboratory tests. Ann Clin Biochem 2010;47:223-7.
27. Goldschmidt HM. Post-analytical factors and their influence on analytical quality specifications. Scand J Clin Lab Invest 1999;59:551-4.
28. Payne PR, Mendonca EA, Johnson SB, Starren JB. Conceptual knowledge acquisition in biomedicine: a methodological review. J Biomed Inform 2007;40:582-602.
29. Laposata M, Dighe A. "Pre-pre" and "post-post" analytical error: high-incidence patient safety hazards involving the clinical laboratory. Clin Chem Lab Med 2007;45:712-9.
30. Laker MF, Reckless JP, Betteridge DJ, Durrington PN, Miller JP, Nicholls DP, et al. Laboratory facilities for investigating lipid disorders in the United Kingdom: results of the British hyperlipi-daemia association survey. J Clin Pathol 1992;45:102-5.
31. Engel JA, Petersen EC, Wilson JE, McManus BM. Progress in blood lipid reporting practices by clinical laboratories in North America. Changes from 1985 to 1990. Arch Pathol Lab Med 1992;116:229-34.
32. Hutchesson AC, O'Kane MJ, Neely RD, Oleesky DA. Provision of laboratory services for lipid analysis in the United Kingdom. Ann Clin Biochem 2007;44:273-80.
33. Kenny D, Fraser CG, Hyltoft Petersen P, Kallner H. Consensus agreement (strategies to set global analytical quality specifications in laboratory medicine-Stockholm). Scand J Clin Lab Invest 1999;59:585.
34. Sikaris K. Application of the Stockholm hierarchy to defining the quality of reference intervals and clinical decision limits. Clin Biochem Rev 2012;33:141-8.
35. Clinical and Laboratory Standards Institute (CLSI). Defining, establishing, and verifying reference intervals in the clinical laboratory: approved guideline, 3rd ed. CLSI Document C28-A3 (ISBN 1-56238-682-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2008.
36. Koumantakis G, Jones G, Tate J. AACB pathology harmonisation organising committee, AACB quality initiatives in pathology-manufacturers reference intervals for common chemistry analytes. Clin Biochem Rev 2011;32:S31.
37. Sonntag O. Is this normal?-This is normal! Implication and interpretation of the so-called normal value. J Lab Med 2003;27:302-10.
38. Jones GR, Barker A, Tate J, Lim CF, Robertson K. The case for common reference intervals. Clin Biochem Rev 2004;25:99-104.
39. Cembrowski GS. Beyond analytical quality: the importance of post-analytical quality in assuring value. Proceedings of the Canadian Society of Clinical Chemistry (CSCC), Saskatoon, June 2010.
40. Berg J, Lane V. Pathology harmony; a pragmatic and scientific approach to unfounded variation in the clinical laboratory. Ann Clin Biochem 2011;48:195-7.
41. Jones GR, Koetsier SD. RCPAQAP first combined measurement and reference interval survey. Clin Biochem Rev 2014;35:243-9.
42. Rustad P, Felding P, Lahti A. Nordic reference interval project 2000. Proposal for guidelines to establish common biological reference intervals in large geographical areas for biochemical quantities measured frequently in serum and plasma. Clin Chem Lab Med 2004;42:783-91.
43. Reed M. The New Zealand approach to harmonised reference intervals. Clin Biochem Rev 2012;33:115-8.
44. Berg J. The UK pathology harmony initiative; the foundation of a global model. Clin Chim Acta 2014;432:22-6.
45. Koerbin G, Sikaris KA, Jones GR, Ryan J, Reed M, Tate J. AACB committee for common reference intervals. Evidence-based approach to harmonised reference intervals. Clin Chim Acta 2014;432:99-107.
46. Ceriotti F. Prerequisites for use of common reference intervals. Clin Biochem Rev 2007;28:115-21.
47. Tate JR, Sikaris KA, Jones GR, Yen T, Koerbin G, Ryan J, et al. Harmonising adult and paediatric reference intervals in Australia and New Zealand: an evidence-based approach for establishing a first panel of chemistry analytes. Clin Biochem Rev 2014;35:213-35.
48. Klee GG. Clinical interpretation and reference intervals and reference limits. A Plea for assay harmonisation. Clin Chem Lab Med 2005;42:752-7.
49. Hyltoft Petersen P, Rustad P. Prerequisites for establishing common reference intervals. Scand J Clin Lab Invest 2004;64:285-92.
50. Sikaris KA. Biochemistry on the human scale. Clin Biochem Rev 2010;31:121-8.
51. Harris EK. Effects of intra-and inter-individual variation on the appropriate use of normal ranges. Clin Chem 1974;20:1535-42.
52. Petersen PH, Sandberg S, Fraser CG, Goldschmidt H. Influence of index of individuality on false positives in repeated sampling from healthy individuals. Clin Chem Lab Med 2001;39:160-5.
53. Fraser CG. Inherent biological variation and reference values. Clin Chem Lab Med 2004;42:758-64.
54. Sikaris KA. Physiology and its importance for reference intervals. Clin Biochem Rev 2014;35:3-14.
55. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993;329:977-86.
56. International Expert Committee. International expert committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care 2009;32:1327-34.
57. Selvin E, Steffes MW, Zhu H, Matsushita K, Wagenknecht L, Pankow J, et al. Glycated hemoglobin, diabetes, and cardiovascular risk in nondiabetic adults. N Engl J Med 2010;362:800-11.
58. International Association of Diabetes and Pregnancy Study Groups Consensus Panel, Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, et al. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care 2010;33:676-82.
59. HAPO Study Cooperative Research Group, Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, et al. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med 2008;358:1991-2002.
60. McIntyre HD, Metzger BE, Coustan DR, Dyer AR, Hadden DR, Hod M, et al. Counterpoint: establishing consensus in the diagnosis of GDM following the HAPO study. Curr Diab Rep 2014;14:497.
61. Vickers AJ, Cronin AM, Björk T, Manjer J, Nilsson PM, Dahlin A, et al. Prostate specific antigen concentration at age 60 and death or metastasis from prostate cancer: case-control study. BMJ 2010;341:c4521.
62. Omland T, de Lemos JA, Sabatine MS, Christophi CA, Rice MM, Jablonski KA, et al. Prevention of Events with Angiotensin Converting Enzyme inhibition (PEACE) trial investigators. A sensitive cardiac troponin T assay in stable coronary artery disease. N Engl J Med 2009;361:2538-47.
63. White GH, Campbell CA, Horvath AR. Is this a critical, panic, alarm, urgent or markedly abnormal result? Clin Chem 2014;60:1589-70.
64. Howanitz PJ, Steindel SJ, Heard NV. Laboratory critical values policies and procedures: a college of American pathologists Q-Probes study in 623 institutions. Arch Pathol Lab Med 2002;126:663-9.
65. Tillman J, Barth JH. ACB national audit group. A survey of laboratory 'critical (alert) limits' in the UK. Ann Clin Biochem 2003;40:181-4.
66. Zeng R, Wang W, Wang Z. National survey on critical values notification of 599 institutions in China. Clin Chem Lab Med 2013;51:2099-107.
67. Campbell CA, Horvath AR. Harmonization of critical result management in laboratory medicine. Clin Chim Acta 2014;432:135-47.
68. Wagar EA, Friedberg RC, Souers R, Stankovic AK. Critical values comparison: a college of American pathologists Q-Probes survey of 163 clinical laboratories. Arch Pathol Lab Med 2007;131:1769-75.
69. Piva E, Sciacovelli L, Laposata M, Plebani M. Assessment of critical values policies in Italian institutions: comparison with the US situation. Clin Chem Lab Med 2010;48:461-8.
70. Table of critical limits. Medical Laboratory Observer. Accessed 6-7 August, 2009.
71. Guerin MD, Martin AL, Sikaris KA. Change in plasma sodium associated with mortality. Clin Chem 1992;38:317.
72. Sikaris KA, Martin A, Guerin MD. Relationship between reference intervals and mortality-based reference ranges. Clin Biochem Rev 1991;12:81.
73. Howanitz PJ, Cembrowski GS. Post-analytical quality improvement: a college of American pathologists Q-Probes study of elevated calcium results in 525 institutions. Arch Pathol Lab Med 2000;124:504-10.
74. Plebani M. The detection and prevention of errors in laboratory medicine Ann Clin Biochem 2010;47:101-10.
75. Kumar SA, Jayanna P, Prabhudesai S, Kumar A. Evaluation of quality indicators in a laboratory supporting tertiary cancer care facilities in India. Lab Med 2014;45:272-7.
76. Sciacovelli L, Plebani M. The IFCC working group on laboratory errors and patient safety. Clin Chim Acta 2009;404:79-85.
77. Plebani M, Astion ML, Barth JH, Chen W, de Oliveira Galoro CA, Escuer MI, et al. Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med. 2014;52:951-8.
78. Abdollahi A, Saffar H, Saffar H. Types and frequency of errors during different phases of testing at a clinical medical laboratory of a teaching hospital in Tehran, Iran. N Am J Med Sci 2014;6:224-8.
79. Guidi GC, Poli G, Bassi A, Giobelli L, Benetollo PP, Lippi G. Development and implementation of an automatic system for verification, validation and delivery of laboratory test results. Clin Chem Lab Med 2009;47:1355-60.
80. Salinas M, López-Garrigós M, Santo-Quiles A, Gutierrez M, Lugo J, Lillo R, et al. Customising turnaround time indicators to requesting clinician: a 10-year study through balanced score-card indicators. J Clin Pathol 2014;67:797-801.
81. Ervasti M, Penttilä K, Siltari S, Delezuch W, Punnonen K. Diagnostic, clinical and laboratory turnaround times in troponin T testing. Clin Chem Lab Med 2008;46:1030-2.
82. Rodríguez-Borja E, Villalba-Martínez C, Carratalá-Calvo A. Enquiry time as part of turnaround time: when do our clinicians really consult our results? J Clin Pathol 2014;67:642-4.
83. Rizk MM, Zaki A, Hossam N, Aboul-Ela Y. Evaluating laboratory key performance using quality indicators in Alexandria university hospital clinical chemistry Laboratories. J Egypt Public Health Assoc 2014;89:105-13.
84. Kirchner MJ, Funes VA, Adzet CB, Clar MV, Escuer MI, Girona JM, et al. Quality indicators and specifications for key processes in clinical laboratories: a preliminary experience. Clin Chem Lab Med 2007;45:672-7.
85. Sciacovelli L, Zardo L, Secchiero S, Zaninotto M, Plebani M. Interpretative comments and reference ranges in EQA programs as a tool for improving laboratory appropriateness and effectiveness. Clin Chim Acta 2003;333:209-19.
86. Barth JH. Clinical quality indicators in laboratory medicine: a survey of current practice in the UK. Ann Clin Biochem 2011;48:238-40.
87. Goldschmidt HM. The NEXUS vision: an alternative to the reference value concept. Clin Chem Lab Med 2004;42:868-73.
88. Hawkins R. Managing the pre-and post-analytical phases of the total testing process. Ann Lab Med 2012;3:5-16.
89. Lau B, Overby CL, Wirtz HS, Devine EB. The association between use of a clinical decision support tool and adherence to monitoring for medication-laboratory guidelines in the ambulatory setting. Appl Clin Inform 2013;4:476-98.
90. Mishuris RG, Linder JA, Bates DW, Bitton A. Using electronic health record clinical decision support is associated with improved quality of care. Am J Manag Care 2014;20:e445-52.
91. Epner PL, Gans JE, Graber ML. When diagnostic testing leads to harm: a new outcomes-based approach for laboratory medicine. BMJ Qual Saf 2013;22(Suppl 2):ii6-10.
92. Smith ML, Raab SS, Fernald DH, James KA, Lebin JA, Grzybicki DM, et al. Evaluating the connections between primary care practice and clinical laboratory testing: a review of the literature and call for laboratory involvement in the solutions. Arch Pathol Lab Med 2013;137:120-5.
93. Gandhi TK, Kachalia A, Thomas EJ, Puopolo AL, Yoon C, Brennan TA, et al. Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med 2006;145:488-96.
94. Kachalia A, Gandhi TK, Puopolo AL, Yoon C, Thomas EJ, Griffey R, et al. Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurers. Ann Emerg Med 2007;49:196-205.
95. Graber ML, Franklin N, Gordon R. Diagnostic error in internal medicine. Arch Intern Med. 2005;165:1493-9.
96. Reason J. Human error. New York, NY: Cambridge University Press, 1990.
97. Berte LM, Nevalainen DE. The laboratory's role in assessing patient outcomes. Lab Med 1998;29:114-9.
98. Norris RL, Martin JH, Thompson E, Ray JE, Fullinfaw RO, Joyce D, et al. Current status of therapeutic drug monitoring in Australia and New Zealand: a need for improved assay evaluation, best practice guidelines, and professional development. Ther Drug Monit 2010;32:615-23.
99. Kristoffersen AH, Thue G, Sandberg S. Post-analytical external quality assessment of warfarin monitoring in primary healthcare. Clin Chem 2006;52:1871-8.
100. Skeie S, Perich C, Ricos C, Araczki A, Horvath AR, Oosterhuis WP, et al. Post-analytical external quality assessment of blood glucose and hemoglobin A1c: an international survey. Clin Chem 2005;51:1145-53.
101. Claustres M, Kožich V, Dequeker E, Fowler B, Hehir-Kwa JY, Miller K, et al. Recommendations for reporting results of diagnostic genetic testing (biochemical, cytogenetic and molecular genetic). Eur J Hum Genet 2014;22:160-70.
102. Piva E, Plebani M. Interpretative reports and critical values. Clin Chim Acta 2009;404:52-8.
103. Page EP, Woodcock SM. The clinical laboratory of the future: re-engineering laboratory services. Can J Med Technol 1994;56:155-60.