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Trace Ability in Laboratory Medicine - References 101029

This document lists 33 references related to traceability in laboratory medicine. Traceability refers to the ability to trace measurements from a test result back to a higher-order reference material and measurement procedure. Several references discuss international standards and guidelines for establishing traceability and reference measurement systems. Other references discuss the importance of traceability and standardization for ensuring accurate and comparable test results across laboratories and over time. The Joint Committee on Traceability in Laboratory Medicine promotes global standardization of clinical laboratory test results through establishing reference measurement systems.

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202 views2 pages

Trace Ability in Laboratory Medicine - References 101029

This document lists 33 references related to traceability in laboratory medicine. Traceability refers to the ability to trace measurements from a test result back to a higher-order reference material and measurement procedure. Several references discuss international standards and guidelines for establishing traceability and reference measurement systems. Other references discuss the importance of traceability and standardization for ensuring accurate and comparable test results across laboratories and over time. The Joint Committee on Traceability in Laboratory Medicine promotes global standardization of clinical laboratory test results through establishing reference measurement systems.

Uploaded by

Pittsford
Copyright
© Attribution Non-Commercial (BY-NC)
We take content rights seriously. If you suspect this is your content, claim it here.
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References- Traceability in Laboratory Medicine

1. Armbruster D, Miller RR. The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a
global approach to promote the standardisation of clinical laboratory test results. Clin Biochem
Rev 2007;28:105–14.
2. CLSI C53-P. Characterization and qualification of commutable reference materials for laboratory
medicine; proposed guideline. CLSI Wayne (PA): CLSI; 2008.
3. CLSI X5-R. Metrological traceability and its implementation; A report. Clinical and Laboratory
Standards Institute. Wayne, PA: CLSI, 2006.
4. DeBievre P, Günzler H, eds. Traceability in chemical measurement. New York: Springer; 2005.
281 p.
5. Dybkäer, René, Joint Committee on traceability in Laboratory Medicine (JCTLM)- A trail-blazing
endeavour. IFCC News March 2002.
6. Eurachem/CITAC guide: traceability in chemical measurements. Cooperation on International
Traceability in Analytical Chemistry. http://www.citac.cc/. (Accessed August 2008).
7. Infusino I, Bonora R, Panteghini M. Traceability in clinical enzymology. Clin Bichem Rev 2007;28:
155–61.
8. ISO 15193:2002. In vitro diagnostic medical devices—measurement of quantities in samples of
biological origin— presentation of reference measurement procedures. Geneva: International
Organization for Standardization; 2002.
9. ISO 15194:2002. In vitro diagnostic medical devices -- Measurement of quantities in samples of
biological origin -- Description of reference materials. Geneva: International Organization for
Standardization; 2002.
10. ISO 15195:2003. Laboratory medicine -- Requirements for reference measurement laboratories.
Geneva: International Organization for Standardization; 2003.
11. ISO 17511:2003. In vitro diagnostic medical devices—measurement of quantities in biological
samples—metrological traceability of values assigned to calibrators and control materials.
Geneva: International Organization for Standardization; 2003.
12. ISO 18153:2003. In vitro diagnostic medical devices—measurement of quantities in biological
samples—metrological traceability of values for catalytic concentration of enzymes assigned to
calibrators and control materials. Geneva: International Organization for Standardization; 2003.
13. ISO Guide 35:2006. Reference materials— general and statistical principles for certification.
Geneva: International Organization for Standardization; 2006.
14. ISO/IEC Guide 99:2007. International vocabulary of basic and general terms in metrology (VIM).
Geneva: International Organization for Standardization; 2007.
15. JCTLM, Database of higher-order reference materials and reference measurement
methods/procedures. http:// www.bipm.org/en/committees/jc/jctlm/jctlm-db.
16. Klee GG. Clinical interpretation of reference intervals and reference limits: a plea for assay
harmonization. Clin Chem Lab Med 2004;42: 752–7.
17. Lequin RM. Traceability in Laboratory Medicine. Biochim Clin 2003;27:230-3.
18. Lewin Group. Laboratory medicine: a national status report. http://www.futurelabmedicine.org/
reports/laboratory_medicine_-_a_national_status_ report_from_the_lewin_group.pdf.
19. Miller WG, Myers GL, Rej R. Why commutability matters. Clin Chem 2006;52:553-4.
20. Müller MM. Implementation of reference systems in laboratory medicine. Clin Chem
2000;46:1907-9.
21. Müller MM. Traceability in laboratory medicine. Accred Qual Assur 2003;8:340-5.
22. National Institute for Standards and Technology. Uncertainty of measurement results.
http://physics. nist.gov/cuu/Uncertainty/ (Accessed October 2008).
23. NIST.The impact of calibration error in medical decision making: planning report 04.1.
http://www.nist.gov/ director/prog-ofc/report04 –1.pdf.
24. Panteghini M, Forest JC. Standardization in laboratory medicine: new challenges. Clin Chim Acta
2005; 355:1-12.
25. Panteghini, Mauro, Traceability, Reference Systems and Result Comparability (Mini-Review). Clin
Biochem Rev Vol 28 August 2007
26. Siekmann L, Doumas BT, Thienpont L, Schumann G. Reference materials and reference
measurement systems in laboratory medicine. Networks of Reference Laboratories. Eur J Clin
Chem Clin Biochem 1995;33: 1013-7.
27. Stanczyk FZ, Lee JS, Santen RJ. Standardization of steroid hormone assays: why, how, and when?.
Cancer Epidemiol Biomarkers Prev 2007;16: 1713–9.
28. Stenman UH. Immunoassay standardization: is it possible, who is responsible, who is capable?
Clin Chem 2001;47:815-20.
29. Thienpont LM, Stöckl D, Friedecky B, Kratochvila J, Budina M. Trueness verification in European
external quality assessment schemes: time to care about the quality of samples. Scand J Clin Lab
Invest 2003;63: 195-201.
30. Thienpont LM, Van Uytfanghe K, De Leenheer AP. Reference measurement systems in clinical
chemistry. Clin Chim Acta 2002;323:73-87.
31. Thienpont LM, Van Uytfanghe K, Rodriguez Cabaleiro D. Metrological traceability of calibration
in the estimation and use of common medical decision-making criteria. Clin Chem Lab Med
2004;42:842-50.
32. Vesper HW, Miller WG, Myers GL. Reference materials and commutability. Clin Biochem Rev
2007;28:139–47.
33. Vesper, Hubert W. and Thienpont, Linda M., Traceability in Laboratory Medicine (Review).
Clinical Chemistry 55:6 1067–1075 (2009)

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