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Clinical Chemistry 48: 2000-2007, 2002;
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(Clinical Chemistry. 2002;48:2000-2007.)
© 2002 American Association for Clinical Chemistry, Inc.

Comparison of Procedures for Evaluating Laboratory Performance in External Quality Assessment Schemes for Lead in Blood and Aluminum in Serum Demonstrates the Need for Common Quality Specifications

Andrew Taylor1a, Jurgen Angerer2, Francoise Claeys3, Jesper Kristiansen4, Olav Mazarrasa5, Antonio Menditto6, Marina Patriarca6, Alain Pineau7, Ilse Schoeters8, Christophe Sykes3, Sinikka Valkonen9 and Cas Weykamp10

1 Centre for Clinical Science and Measurement, School of Biomedical and Life Sciences, University of Surrey, Guilford GU2 7XH, United Kingdom.

2 Institute of Occupational, Social and Environmental Medicine, University of Erlangen-Nuernberg, 91054 Erlangen, Germany.

3 Unit of Epidemiology, Scientific Institute of Public Health, B-1050 Brussels, Belgium.

4 National Institute of Occupational Health, 2100 Copenhagen, Denmark.

5 Higiene Industrial, Centro de Seguridad y Salud en el Trabajo, Gobierno de Cantabria, 39012 Santander, Spain.

6 Laboratorio di Biochimica Clinica, Istituto Superiore di Sanità, 00161 Rome, Italy.

7 Laboratoire de Toxicologie, UFR de Pharmacie, Université de Nantes, 44035 Nantes, France.

8 Association Européenne des Metaux, 1150 Brussels, Belgium.

9 Biomonitoring Laboratory, Topeliuksenkatu 41aA, Finnish Institute of Occupational Health, FIN-02500 Helsinki, Finland.

10 MCA Laboratory, Queen Beatrix Hospital, 7101 BN Winterswijk, The Netherlands.

aAddress correspondence to this author at: Centre for Clinical Science and Measurement, School of Biomedical and Life Sciences, University of Surrey, Guildford, Surrey GU2 7XH, United Kingdom. Fax 44-1483-689979; e-mail A.Taylor{at}surrey.ac.uk.

Background: The different scoring methods used by eight European External Quality Assessment Schemes (EQASs) for occupational and environmental laboratory medicine were compared to develop suitable quality specifications as a step toward harmonization.

Methods: Real results for blood lead and serum aluminum assays, reported by participants in Italian and United Kingdom EQASs, were evaluated according to individual scheme scoring criteria. The same results were then used to produce z scores using scheme-based between-laboratory SDs as the estimate of variability to determine whether simple performance-derived quality specifications produced better agreement among schemes.

Results: The schemes gave conflicting assessments of participants’ performance, and participants judged to be successful by one scheme could be defined as performing inadequately by another. An approach proposed by Kenny et al. (Scand J Clin Lab Invest 1999;59:585), which uses clinical inputs to set targets for analytical imprecision, bias, and total error allowable, was then used to elaborate quality specifications.

Conclusions: We suggest that the CLIA '88 recommendations for blood lead (± 40 µg/L or ± 10% of the target concentration, whichever is the greater) could be used as a quality specification, although a revision to ± 30 µg/L or ± 10% is recommended. For serum aluminum, a suitable quality specification of ± 5 µg/L or ± 20% of the target concentration, whichever is the greater, is suggested. These specifications may be used to compare laboratory performance across schemes.




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M. Patriarca, M. Castelli, F. Corsetti, and A. Menditto
Estimate of Uncertainty of Measurement from a Single-Laboratory Validation Study: Application to the Determination of Lead in Blood
Clin. Chem., August 1, 2004; 50(8): 1396 - 1405.
[Abstract] [Full Text] [PDF]


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