ANSI - American National Standards Institute
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How Do Standards Support National Blood Donor Month?


During national blood donor month, the American Red Cross reminds us that safe blood not only improves the health of people with specific medical conditions, it can also save lives. Blood donations can help millions in need: every two seconds, someone in the U.S. needs blood.

This year, the American Red Cross has issued an emergency call for blood and platelet donations due to a severe winter blood shortage. As donors file into medical centers and blood centers, the American National Standards Institute (ANSI) supports safe blood transfusions through related standardization efforts:

The Clinical and Laboratory Standards Institute (CLSI), an ANSI-accredited standards developing organization, has published standards for blood collection and laboratory testing.

CLSI GP44-A4, Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline - Fourth Edition, addresses handling and processing of blood specimens for examination procedures using serum, plasma, or whole blood in the clinical laboratory. It also specifies criteria to assist the laboratory and other health care providers in recognizing and reducing or eliminating pre-examination errors resulting from improper handling of blood specimens.

Another component of blood transfusion includes a standard developed by ANSI member and accredited standards developer AAMI, the Association for the Advancement of Medical Instrumentation. This American National Standard, ANSI/AAMI BF64:2012, Leukocyte Reduction Filters, contains labeling requirements, performance requirements, test methods, and terminology for disposable filters used for the reduction of leukocytes from blood or blood products during transfusion.

Finally, ISO 1135-3:2016, Transfusion equipment for medical use -- Part 3: Blood-taking set for single use, provides guidance for transfusion equipment for a single use and for a single donor.

Published by the International Organization for Standardization (ISO), this standard was developed by ISO Technical Committee (TC) 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use, Working Group (WG) 5, Blood collection systems. AAMI services as the ANSI-accredited U.S. Technical Advisory Group (TAG) administrator to this TC, carrying U.S. positions forward to the committee. ANSI is the U.S. member body to ISO.

For more information on how to donate blood, visit the American Red Cross webpage.