The Clinical and Laboratory Standards Institute (CLSI) recently published "Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guideline" (GP34-A). This document provides step-by-step recommendations for the validation and verification of venous and capillary blood collection devices.
Nancy Dubrowny, MS, MT(ASCP)SC, BD Preanalytical Systems, and chairholder of the subcommittee that developed the guideline, says, "One benefit of this document is that it provides a recommendation for tube manufacturers on a process that can be used to demonstrate, through clinical evaluations, the safety and efficacy of their newly developed blood collection containers. In addition, clinical laboratories can use GP34-A to ensure that there is no contribution to measurand interference from blood collection containers used in their institutions."
Dubrowny adds: "It has long been recognized that blood collection tube manufacturers and clinical laboratories have a responsibility to ensure that all patients' blood test results are accurate and precise. We now have a guidance document from CLSI that will provide details for tube manufacturers and clinical laboratories to consider for this purpose."
The document includes guidance for ascertaining the acceptability/compatibility for clinical performance in clinical chemistry, immunochemistry, hematology, and coagulation. The GP34-A document can benefit manufacturers of venous and capillary blood collection devices; assay/instrument manufacturers; all clinical laboratory personnel; and those responsible for the acquisition, handling, and use of the equipment described in this document.
Also recently published is the revised document "Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard-Sixth Edition" (H01-A6), a performance standard for manufacturers of venous and capillary blood collection tubes and additives for serum, plasma, and whole blood testing. H01-A6 addresses requirements for the materials, construction, and labeling of venous and capillary blood collection tubes and tube assemblies.
"The guidance for H01-A6 centers around the different components used to make blood collection tubes and the performance requirements of these components. Newly added to the Identification section was additional lot number and expiration dating requirements," said Dubrowny.
CLSI and the Association of Public Health Laboratories (APHL) have announced a related teleconference to GP34-A: Using GP34 to Document Blood Collection Tube Performance in Your Lab, February 17, 1:00-2:00 PM Eastern (US) Time.
More details and registration information for the upcoming teleconferences can be found at www.aphl.org/clsi