Quality and reliability of routine coagulation testing: can we trust that sample?

Area of Science:

• Clinical Chemistry
• Hematology
• Laboratory Medicine

Background:

• Preanalytic variables significantly impact the reliability of coagulation testing.
• Inconsistent patient identification, specimen collection, and handling procedures are major sources of error.
• Factors like venous access, phlebotomy technique, and specimen processing introduce variability.

Purpose of the Study:

• To highlight the critical role of preanalytic standardization in coagulation testing.
• To identify common pitfalls in specimen collection and handling that affect test results.
• To emphasize the need for standardized procedures, especially for advanced assays like thrombin generation.

Main Methods:

• Review of established preanalytic variables affecting routine coagulation assays.
• Identification of specific criteria for thrombin-generation assays, including specimen type and storage.
• Discussion of international quality assessment programs and their implications for laboratories.

Main Results:

• Poor standardization leads to unreliable coagulation test results, increased healthcare costs, and compromised patient care.
• Venous stasis, hemoconcentration, hemolysis, and improper tube filling/mixing are key preanalytic issues.
• Thrombin-generation assays have unique preanalytic requirements beyond routine coagulation tests.

Conclusions:

• Implementing standardized preanalytic procedures is essential for improving the accuracy and reliability of coagulation testing.
• Addressing preanalytic variability is achievable through structured resource allocation, education, and adherence to guidelines.
• Standardization efforts are vital for compliance with emerging international quality assessment programs in coagulation laboratories.