Preanalytical Nonconformity Management Regarding Primary Tube Mixing in Brazil.

Area of Science:

• Clinical Laboratory Science
• Preanalytical Phase Optimization
• Patient Safety

Background:

• The preanalytical phase accounts for over 60% of laboratory errors.
• Nonstandardized procedures in primary blood tube mixing are a significant concern.
• This study focuses on venipuncture with evacuated tube systems.

Purpose of the Study:

• To investigate nonconformity in primary blood tube mixing after venipuncture.
• To assess the impact of mixing practices on laboratory errors and hemolysis.
• To determine if avoiding tube mixing constitutes a nonconformity in accreditation.

Main Methods:

• Surveyed 50 Brazilian laboratory quality managers for internal audit reports.
• Focused on nonconformity related to primary blood tube mixing post-venipuncture.
• Analyzed audit data on mixing procedures and frequency from January 2015 to December 2015.

Main Results:

• Only 4% of audits identified inaccurate blood tube mixing.
• Over 50% reported vigorous mixing, increasing hemolysis risk.
• Mixing frequency often deviated from manufacturer recommendations.

Conclusions:

• Vigorous mixing can cause spurious hemolysis.
• Standard vacuum pressure may suffice for blood-additive mixing.
• Avoiding primary tube mixing may not be a nonconformity and unlikely to bias test results.