Implementing the Stockholm Conference hierarchy of objective quality criteria in a routine laboratory

Clinical Chemistry and Laboratory Medicine

Volumn 45, Issue 4, 2007, Pages 549-552

  Dhatt, Gurdeep S ^a   Agarwal, Mukesh M ^b   Bishawi, Bassam ^a   Gill, Janice ^c  

^a TAWAM HOSPITAL   (United Arab Emirates)

^b UNITED ARAB EMIRATES UNIVERSITY   (United Arab Emirates)

^c RCPA Quality Assurance Programs Pty Limited   (Australia)

Author keywords

Biological variation; Imprecision; Objective; Quality; Specifications

Indexed keywords

ANALYTIC METHOD; ARTICLE; CLINICAL LABORATORY; DATA ANALYSIS; DIAGNOSTIC ACCURACY; PERFORMANCE; PRIORITY JOURNAL; QUALITY CONTROL; STANDARD;

LABORATORIES; QUALITY CONTROL; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS;

EID: 34247368937     PISSN: 14346621     EISSN: 14374331     Source Type: Journal    
DOI: 10.1515/CCLM.2007.105     Document Type: Article

References (14)

1. Westgard JO, Carey RN, Wold S. Criteria for judging precision and accuracy in method development and evaluation. Clin Chem 1974;20:825-33.
2. Tonks DB. A study of the accuracy and precision of clinical chemistry determinations in 170 Canadian laboratories. Clin Chem 1963;9:217-33.
3. Barnett RN. Medical significance of laboratory results. Am J Clin Pathol 1968;50:671-6.
4. Cotlove E, Harris EK, Williams GZ. Biological and analytic components of variation in long-term studies of serum constituents in normal subjects. 3. Physiological and medical implications. Clin Chem 1970;16:1028-32.
5. Kallner A, McQueen M, Heuck C. The Stockholm Consensus Conference on quality specifications in laboratory medicine, 25-26 April 1999. Scand J Clin Lab Invest 1999;59:475-6.
6. Kenny D, Fraser CG, Petersen PH, Kallner A. Consensus agreement. Scand J Clin Lab Invest 1999;59:585.
7. Ricós C, García-Lario JV, Alvarez V, Cava F, Domenech M, Hernández A, et al. Biological variation database, and quality specifications for imprecision, bias and total error. The 2006 update. www.westgard.com. Accessed September 11, 2006.
8. Warnick GR, Myers GL, Cooper GR, Rifai N. Impact of the third cholesterol report from the adult treatment panel of the national cholesterol education program on the clinical laboratory. Clin Chem 2002;48:11-17.
9. Fraser CG, Hyltoft Petersen P, Libeer JC, Ricos C. Proposals for setting generally applicable quality goals solely based on biology. Ann Clin Biochem 1997;34:8-12.
10. In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials. ISO 17511:2003.
11. Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on In Vitro Diagnostic Medical Devices. Off J Eur Union L331, December 12, 1998.
12. Fraser CG. Test result variation and the quality of evidence-based clinical guidelines. Clin Chim Acta 2004;346:19-24.
13. Jackson CM, Wielgosz RI, May WE. An international effort to achieve comparability of test results. IVD Technology 2006;24, http://www.devicelink. com. Accessed September 15, 2006.
14. Medical laboratories. Particular requirements for quality and competence. ISO 15189:2003.