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Comments to CMS on Continued Use of the Hemoglobin – Copper Sulfate – Non-automated Test

January 6, 2015

Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-3271-P
P.O. Box 8010
Baltimore, MD 21244-1850

Re: CMS-3271-P; Federal Register, Volume 79, Number 216, November 7, 2014, inclusive of a solicitation of “comments to determine if the waived test at
§ 493.15(c)(6) Hemoglobin – copper sulfate – non-automated is still in use”

Dear Dockets Manager,

AABB is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety. AABB membership consists of nearly 2,000 institutions and 8,000 individuals, including physicians, nurses, scientists, researchers, administrators, medical technologists and other health care providers. AABB members are located in more than 80 countries.

We appreciate the opportunity to provide you the information that the Hemoglobin – copper sulfate – non-automated test is still in use and should not be removed from the regulation [§ 493.15(c)(6)].

AABB heard from members across the United States who continue to use the copper sulfate method as a primary method for determining hemoglobin of blood donors. The member blood collectors are of various sizes, ranging from approximately 100,000 collections per year to somewhat less than 10,000. It is possible that other collection facilities use the copper sulfate method as a back-up procedure. We believe that CMS received responses directly from some, if not all, of the members that contacted AABB.

Please contact me at or 919.658.1689 if you require additional information.


M. Allene Carr-Greer
Director, Regulatory Affairs