Thursday, April 28, 2005
30

LABORATORY ANALYTICAL PERFORMANCES: CAN EXTERNAL QUALITY ASSESSMENT SCHEMES (EQAS) STIMULATE THE IMPROVEMENT?

Laura Sciacovelli, Martina Zaninotto, and Mario Plebani.


Context:
EQAS aim at improving laboratory performances through education, scientific recommendations and standardisation taking into account clinical needs and quality specifications.

Objective:
The aim of this work is to show the results of an Italian experience in EQAS for Biochemical Markers of Myocardial Damage as regards the procedures to investigate and solve the unacceptable performances (UP) obtained by participants.

Methods:
In order to investigate the causes of the unexpected number of UP for Troponin I (cTnI) and Troponin T (cTnT) obtained in the Cycle 2004 (1, 2 and 3 surveys), we did search for a more effective co-operation between laboratories and manufacturers of diagnostic systems. In particular, we sent the participants a questionnaire on tests calibration and internal quality control (IQC) management and about the handling of EQA materials before the analytical phase in relation to specific operative procedures. Moreover, the specialists of diagnostic systems supported the laboratories assuring a better control of all analytical variables.

Results:
The evaluation of the laboratories' answers underlines an inaccurate application of procedures for the validation of calibration and for EQA material handling, and a poor management of IQC. Therefore, brief instructions emphasizing the aspects to be carefully controlled have been written and distributed to all participants in agreement with manufacturers.
Consequently, in 4, 5 and 6 surveys, the total number of UP for cTnI, calculated only on diagnostic systems numerically more relevant (Abbott Axsym, Beckman Access, Dade Behring Dimension) has been reduced from 44.3% to 32.9% for low concentrations and from 34.8% to 14.3% for high concentrations. For cTnT the number of UP remained high (about 60%) and further investigations are necessary to identify the problems.


Conclusions:
Our findings show that the collaboration among laboratories, EQA organizers and manufacturers is essential to help laboratory staff, to identify any problems and to promote continuous improvement in performances.

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See more of The 2005 Institute for Quality in Laboratory Medicine Conference