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Comments to CMS on the Proposed Rule "Changes to CLIA Enforcement Actions for Proficiency Testing Referral"

November 18, 2013

Marilyn Tavenner
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: CMS-1443-P "Medicare Program; Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for Rural Health Clinics; and Changes to Clinical Laboratory Improvement Amendments of 1988 Enforcement Actions for Proficiency Testing Referral"

Dear Ms. Tavenner:

AABB appreciates the opportunity to comment on the proposed changes to Clinical Laboratory Improvement Amendments (CLIA) regulations regarding enforcement actions for proficiency testing referral.  AABB (formerly known as the American Association of Blood Banks) is a not-for-profit association representing individuals and institutions involved in transfusion medicine and cellular therapy. Our membership consists of nearly1,800 institutions, including hospital-based blood banks and laboratories, transfusion services and blood and bone marrow collection facilities, as well as approximately 8,000 individuals involved in blood, bone marrow, cord blood and peripheral blood stem cell collection, processing, storage and infusion. 

In general, AABB commends CMS on the proposed changes that will allow for alternate categories of sanctions for Proficiency Testing referrals.  AABB is concerned though that CMS' proposal to require civil monetary penalties (CMPs) for even minor, unintentional infractions is excessive.  It is appropriate to require corrective actions, such as education of laboratory staff where an accidental referral occurred.  However, AABB urges CMS to reconsider imposing a CMP for inadvertent referrals. 

Thank you again for the opportunity to offer these comments.  If you have any questions regarding these comments or would like additional information, please contact AABB Director of Public Policy Theresa Wiegmann at 


Jean Otter, MT(ASCP)SBB
Division Director, Standards, Accreditation & Education Programs