The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico - a multicentric study.

ABSTRACT

BACKGROUND: This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytical phase of laboratory activities in some developing European countries and Mexico. We assessed the quality of the extra-analytical practices in participating laboratories regarding the a) sample acceptance criteria; b) phlebotomy procedures; c) test results reporting and d) recording non-conformities. METHODS: A survey was performed during the April-May 2009. A total of 15 clinical laboratories from the following countries were included Bosnia, Croatia, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine. Questions were scored (scores from 1-4) and average scores was calculated for each category. RESULTS: The overall score for all respondents (n = 443) was 3.10 ± 0.33. The average score was 3.11 ± 0.56 for sample acceptance criteria, 2.76 ± 0.58 for phlebotomy and 3.34 ± 0.53, for test results reporting (F = 116.49; p < 0.001). Laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures (F = 16.62; p < 0.001). Moreover, the highest scores for sample acceptance criteria (F = 8.32; p < 0.001), phlebotomy procedures (F = 13.28; p < 0.001) and for reporting non-conformities (F = 33.62; p < 0.001) were observed for accredited laboratories or laboratories under preparation for accreditation. CONCLUSIONS: The overall quality of the extra-analytical practices in countries in this survey is not satisfactory. Phlebotomy practices are the most critical extra-analytical activity. Since laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures, we believe that the most significant improvement could be made by implementing the total quality management system and standardizing laboratory procedures.