Preanalytical quality control program - an overview of results (2001-2005 summary)

Preanalytical errors can impact diagnostic accuracy. Prior research has shown that sample collection, handling, and transport are vulnerable to mistakes. It was already known that standardized procedures may reduce such errors. However, no prior work had resolved the specific contribution of different sample types and rejection causes. This gap motivated a need to analyze patterns of sample rejection across multiple laboratories. Existing studies lacked detailed data on rejection rates by sample type. That uncertainty drove the need for a comprehensive retrospective analysis. The study aimed to clarify which factors most commonly led to rejection. No prior work had summarized rejection rates for whole blood-EDTA and serum samples specifically. This paper contributes to understanding how preanalytical errors vary by sample type and rejection reason.

The study aimed to summarize preanalytical error patterns across multiple laboratories. It focused on identifying the most common causes of sample rejection. The researchers sought to determine how rejection rates varied by sample type. They also aimed to assess whether certain variables were irrelevant to rejection rates. The goal was to inform quality control improvements in clinical laboratories. The study sought to provide data to guide standardization efforts. It aimed to clarify whether some variables could be removed from quality programs. The purpose was to evaluate the effectiveness of preanalytical quality control measures.

The study used a retrospective analysis of data collected from 2001 to 2005. Participants were asked to register rejections and their causes. The data came from 105 laboratories participating in a quality assessment program. The researchers analyzed the number of tubes expected versus those received. They categorized rejections by sample type and rejection reason. The study compared rejection rates across different sample types. They calculated the percentage of rejections for each cause. The researchers also evaluated the relevance of variables included in the program.

Of 4,715,132 expected tubes, 32,977 were rejected, a rate of 0.699%. Whole blood-EDTA and serum samples made up 75.6% of all samples collected. However, these samples accounted for 55.8% of all rejections. The top three rejection reasons were specimen not received (37.5%), hemolysis (29.3%), and clotted sample (14.4%). Plasma-citrate-erythrocyte sedimentation rate had the highest rejection rate (1.473%). Whole blood-EDTA had the lowest rejection rate (0.381%). The overall rejection rate matched previously published data. The program was simplified in 2006 due to irrelevant variables.

The study found that specimen not received, hemolysis, and clotted samples were the main causes of rejection. Whole blood-EDTA and serum samples were collected most frequently but had higher rejection rates. Plasma-citrate samples had the highest rejection rate. The overall rejection rate was consistent with prior studies. The researchers proposed that some variables could be removed from the quality program. They suggested that simplifying the program could improve efficiency. The findings may inform future quality control strategies. The authors did not propose new directions beyond program simplification.