October 03, 2012
Senator Tom Harkin
731 Hart Senate Office Building
Washington, DC 20510
Dear Senator Harkin:
On behalf of AABB, I am writing to request your support for the Taking Essential Steps for Testing Act, (S. 3391), introduced by Senator Amy Klobuchar. This bill would allow for more reasonable and appropriate penalties for proficiency testing (PT) referral under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Companion legislation, H.R. 6118, recently passed the House of Representatives.
AABB (formerly known as the American Association of Blood Banks) is a not-for-profit professional and standard-setting organization dedicated to advancing transfusion medicine and cellular therapies. Our membership includes approximately 1,800 institutions (including virtually every blood center in the United States) and 8,000 individuals involved in all aspects of blood and stem cell collection, processing, transfusion and transplantation.
Proficiency testing is an important means of measuring laboratory quality. Laboratories are sent unknown specimens to be tested three times per year for the purpose of monitoring the quality of their performance compared to other laboratories. (An actual patient sample is not sent, although it is required that proficiency samples be treated the same as a patient's sample would be.) Currently, CLIA imposes automatic, severe sanctions for the referral of a proficiency test sample to an outside laboratory; a facility's CLIA certificate is revoked for one year and the laboratory director is barred from acting in such a capacity for two years. In imposing these sanctions, the Centers for Medicare and Medicaid Services (CMS) has no discretion to consider whether the referral was made intentionally or not. As a result, extremely harsh sanctions have been levied against laboratories, including blood centers, and their laboratory directors, even for an inadvertent referral.
AABB strongly supports and shares CMS' goal of ensuring quality laboratory services. However, patients will not be served if blood centers or other laboratories that accidentally make PT referrals face potential shutdown or disruption in patient or donor care.
S. 3391 would provide CMS with needed flexibility to match the severity of the sanctions it imposes for PT referral to the severity of the noncompliance. PT referral would still be prohibited and CMS could impose strict sanctions if it determined that the laboratory intended to circumvent the testing process by making the referral. Alternatively, if the referral was inadvertent, CMS could impose more reasonable penalties.
AABB urges you to support prompt passage of this legislation.
Karen L. Shoos, JD
Chief Executive Officer