14 April 2010
Plasma Protein Therapeutics Association
147 Old Solomons Island Road
Annapolis, MD 21401
Via email: Michelle Mason at firstname.lastname@example.org
RE: Draft recovered plasma specification prepared for addition to QSEAL
AABB is an international association dedicated to advancing transfusion and cellular therapies worldwide. Our members include more than 1,800 hospital and community blood centers and transfusion and transplantation services as well as approximately 8,000 individuals involved in activities related to transfusion, cellular therapies and transplantation medicine. For over 50 years, AABB has established voluntary standards for, and accredited institutions involved in, these activities. AABB is focused on improving health through the advancement of science and the practice of transfusion medicine and related biological therapies, and developing and delivering programs and services to optimize patient and donor care and safety.
The AABB Interorganizational Plasma Task Force appreciates the opportunity to provide feedback to the draft recovered plasma specification during the open comment period. Representation on this task force is provided by members from AABB, the American Red Cross, America’s Blood Centers, Armed Services Blood Program, Blood Centers of America, Blood Systems Incorporated, Canadian Blood Services, Hema-Quebec, Baxter BioScience, Octapharma, and CSL Plasma, as well as PPTA. The task force is commenting on the content of the draft specification. Submission of comments should not be taken as approval of PPTA’s development of standards for volunteer plasma.
The task force has one comment to the recovered plasma specification, specifically to the phrase “Viral Marker Rate Standard under development” found on page 3:
Viral Marker Reporting
Epidemiological data must be collected on those blood-borne infectious agents for which a potential transmission by blood products is well recognized and routine testing of blood and plasma donations is mandatory. These infectious agents currently include human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV). Collector shall collect data for viral marker rates for each marker performed and report the viral marker rates to the manufacturer in a mutually agreed upon format.
Viral Marker Rate Standard under development
Recommendation: The AABB Interorganizational Plasma Task Force strongly recommends to PPTA that any viral marker rate standard be proposed in a collaborative manner and posted as a draft for public comment. Further, the task force recommends that the phrase “Viral Marker Rate Standard under development” be removed from this document at this time.
Questions concerning this communication can be directed to M. Allene Carr-Greer at email@example.com.
Susan L. Wilkinson
Chair, AABB Interorganizational Plasma Task Force