September 14, 2007
Judith A Yost, Director
Division of Laboratory Services
Survey and Certification Group
Centers for Medicare & Medicaid Services
7500 Security Boulevard (S2-12-25)
Baltimore, MD 21244-1850
As of March 1, 2004, all AABB accredited facilities were required to have a method to limit and detect bacterial contamination in all platelet components (Standard 126.96.36.199, AABB Standards for Blood Banks and Transfusion Services, 22nd edition). When bacterial detection testing of platelets was first required, it was considered by CMS as a quality control test and, as such, not a CLIA-regulated test. However, in 2006, CMS notified AABB that because AABB had issued Association Bulletin 05-02 “Guidance on Management of Blood and Platelet Donors with Positive or Abnormal Results on Bacterial Contamination Tests”, which provided guidance for medical decision-making in managing donors with a positive result on a test for bacterial contamination in donated platelets, bacterial detection testing was now to be considered a test regulated under CLIA and subject to all applicable CLIA regulations.
This change in status from QC test to CLIA-regulated test has resulted in an unforeseen consequence to one of the manufacturers of bacterial detection tests. The eBDS system, manufactured by Pall, was licensed by the FDA as a quality control test. When Pall requested test categorization for CLIA by the Center for Devices and Radiological Health (CDRH), Pall was notified that the test would not be categorized, as it was a QC test. Because it is not categorized, it automatically defaults to a high complexity test under 42 CFR 493.17(c)(4). As a result, laboratories using the eBDS system must use testing personnel that meet the requirements for high complexity testing. Pall cannot re-apply for licensure for eBDS as a release test (which would allow CDRH to categorize the test), because the system does not test for anaerobic organisms.
AABB respectfully requests that CMS work with FDA to allow for the proper categorization of the eBDS test system. It is our concern that if laboratories must continue to meet requirements for high complexity testing for the eBDS system, that the labs will decide to change their testing method to pH and/or glucose testing, which are far less accurate methods of detecting bacterial contamination in platelets.
We thank you in advance for your assistance. If you have any questions or require any additional information, please do not hesitate to contact me at Holly_r@aabb.org or 301.215.6523.
Holly Rapp, MT(ASCP)SBB, CQA(ASQ)CQMgr
Director, Department of Accreditation and Quality