Quality assurance using patient split samples: recommendations for primary healthcare laboratories

Area of Science:

• Laboratory Medicine
• Primary Healthcare Quality Assurance

Background:

• Point-of-care testing (POCT) adoption in primary healthcare necessitates robust quality assurance (QA).
• The patient split sample approach (comparing POCT with central laboratory results) is a valuable QA tool.
• Practical guidance for implementing patient split sample analysis in primary healthcare is limited.

Purpose of the Study:

• To develop user-friendly recommendations for non-laboratory personnel in primary healthcare.
• To provide clear guidance on when and how to perform patient split sample comparisons.
• To establish acceptable limits for comparing POCT and central laboratory results.

Main Methods:

• An expert group formulated recommendations based on literature review and professional experience.
• Pragmatic acceptability limits were established using multiple approaches.
• Recommendations were refined through an audit involving over 120 employees.

Main Results:

• Patient split sample comparisons are recommended when EQA programs are absent, internal QC is inadequate, or POCT results conflict with clinical expectations.
• Acceptable limits for result comparison were set at 15% or 20%, varying by measurand.
• A structured checklist is advised for reviewing results outside these limits.

Conclusions:

• These represent the first published, user-friendly recommendations for patient split sample use in primary healthcare.
• The guidelines aim to simplify implementation for non-laboratory personnel.
• Widespread adoption of these QA procedures is anticipated to improve POCT reliability.