The quality of the extra-analytical phase of laboratory practice in some developing European countries and Mexico - a multicentric study.
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.
University Department of Chemistry, Emergency Laboratory Department, University Hospital SESTRE MILOSRDNICE Zagreb, Croatia. am.simundic@gmail.com
Ana-Maria
AM
Simundic
Lidija
L
Bilic-Zulle
Nora
N
Nikolac
Vesna
V
Supak-Smolcic
Lorena
L
Honovic
Sanja
S
Avram
Elena
E
Beregovaja
Minodora
M
Dobreanu
Joao-Tiago
JT
Guimaraes
Gabor L
GL
Kovacs
Nada Majkic
NM
Singh
Rosa Isabel
RI
Sierra-Amor
Grazyna
G
Sypniewska
Tomas
T
Zima
D000328:Adult; D000368:Aged; D019411:Clinical Laboratory Techniques / Q000592:standards / Q000706:statistics & numerical data*; D003906:Developing Countries / Q000706:statistics & numerical data*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008800:Mexico; D008875:Middle Aged; D018962:Phlebotomy / Q000706:statistics & numerical data; D011786:Quality Control; D012107:Research Design / Q000592:standards / Q000706:statistics & numerical data; D057566:Self Report / Q000592:standards; D011795:Surveys and Questionnaires; D055815:Young Adult