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

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 nonconformities. 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. 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, highest scores for sample acceptance criteria (F=8.32 ; P<0.001), phlebotomy procedures (F=13.28 ; P<0.001) and for reporting nonconformities (F=33.62 ; P<0.001) were observed for accredited laboratories or laboratories under preparation for accreditation. 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 the laboratory procedures.