Ann Lab Med.  2012 May;32(3):216-219. 10.3343/alm.2012.32.3.216.

Analysis of Factors Influencing the Generation of Unqualified Clinical Samples and Measures to Prevent this Generation

• Lai X
• Yang P
• Zhang Y
• Cao J
• Zhang L

• KMID: 1381688
• DOI: http://doi.org/10.3343/alm.2012.32.3.216

Abstract

BACKGROUND
We investigated the influence of pre-analytical factors on the results of clinical tests and thereby analyzed approaches to improve quality management in clinical laboratories.
METHODS
Unqualified clinical samples were selected from all the samples received at our clinical laboratory. The data were collected for 2009 and 2010, i.e., the years before and after the establishment of the laboratory quality management system. The rate and causes of generation of unqualified samples were analyzed, and measures to improve the laboratory practices were studied and implemented.
RESULTS
A total of 1,051 unqualified samples were identified from among the 553,158 samples (the overall incidence rate of unqualified samples was 0.19%). The number of unqualified samples substantially varied according to the nature of the sample, and clinical samples collected for routine blood tests or coagulation tests were the predominant unqualified samples. The main causes of generation of unqualified samples were insufficient sample volumes and improper methods of mixing the samples. The rate of generation of unqualified samples decreased significantly after the implementation of improvement measures (0.26% in 2009 vs. 0.13% in 2010, P<0.001).
CONCLUSIONS
The number of unqualified samples decreased significantly after the establishment of the laboratory quality management system, which promoted active communication among and training of the clinical staff to reduce the occurrence of pre-analytical errors. Comprehensive control of pre-analytical factors is an important approach in improving the clinical laboratory practices.

Keyword

Quality management; Clinical laboratory; Analysis; Samples

MeSH Terms

Clinical Laboratory Techniques/standards
Diagnostic Errors/statistics & numerical data
Humans
Laboratories, Hospital/*standards
Specimen Handling/standards

Figure

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  Fig. 1 Monthly changes in the rate of generation of unqualified samples.

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  Fig. 2 Comparison of the types of unqualified samples generated in 2009 and 2010. Significant decrease in the proportion of unqualified samples was observed in 2010 compared to 2009 (P<0.001).

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