Noteworthy Issues in Cellular Therapy
A quarterly update on critical issues.
WINTER 2008
Next Practice Snapshot to Cover Environmental, Personnel Monitoring.
The next practice snapshot will be part of a series on environmental monitoring and personnel monitoring practices. The first of the series will cover environmental monitoring of 361 products as described in 21 CFR part 1271. The second, which will follow two weeks later, will apply to 351 products. Your responses are important as we assess current practices. Please take a minute now and click here to complete this brief survey, it will be available for the next 10 days. For past practice snapshots, click here.
Increase Your Reimbursement for Cell Processing
After a long battle, CMS is finally recognizing the bone marrow/stem cell processing codes for payment under the Hospital Outpatient Prospective Payment System. Since future payments will be based on the cost and charge data reported by hospitals, it is critical that all cell therapy laboratories bill appropriately. If you haven’t already done so, NOW is the time to update your charge master. Enlist the help of finance administrators, and remember that product quality control tests and laboratory director and quality assurance time should be included in these charges. The future of reimbursement truly is in your hands. Coming soon — more details on this topic, including a frequently asked questions document on the AABB Web site.
Spring Conference Is Budding with New Ideas!
Unsure of the difference between facility monitoring and product surveillance? Want to streamline process control and change control? Like to know what others are doing about red cell removal? Want to get all of your quality and technical questions answered in an intimate setting and avoid “microphonophobia”? Whether your quality plan is merely a concept or an existing version in need of some major revision, the AABB Spring Conference offers practical solutions on where to start and how to proceed. Additionally, participants will learn common problems encountered in flow cytometry assays for cell therapy products, the latest high-tech approaches to generating organs in the lab and FDA's evoloving perspective on deviation reporting. Join your colleagues in Orlando, and return with fresh ideas for your program. Early discount registration ends tomorrow.
FDA Clarifies HCT/P Requirements
FDA has clarified its definition of several practices that affect facility registration requirements on its form 3356. The agency indicated that it considers donor screening and testing, not product testing, as facility testing functions. In addition, microbiological testing of products is considered processing, not testing. Therefore, facilities performing microbial testing on products, should register for processing, not testing for this function. This also means that microbial test methods should be validated or qualified, as are other processing methods in the manufacturing process. Information about this issue as well as other regulatory matters, including donor eligibility and compliance activities, were discussed at the recent Pharma Conference presented in cooperation with AABB. Presentations from the conference are expected to be posted in the coming weeks on the FDA Web site.
Upcoming Audioconference to Focus on Selecting the Best Product for Allogeneic Transplant Recipients
AABB will host an audioconference this spring focusing on the use of apheresis products in hematopoietic cell transplantation. The April 23 audioconference, developed in cooperation with ASBMT, will include a review of the current data supporting the choice of either peripheral blood or marrow as an allogeneic stem cell source, address the role of granulocyte transfusions in these patient populations and conclude with a discussion of how relapses after hematopoietic cell transplantation are managed, with a focus on the role of donor lymphocyte infusions. Register today.
Get Those Passports Ready!
The 2008 AABB Annual Meeting & TXPO will take place Oct. 4-7 in Montreal. Mark your calendars for this event, and don’t forget to submit an abstract in transplantation, cellular therapies, cell processing, or donor suitability and testing by the April 18 deadline. This year’s meeting will have plenty to offer, including an expanded cell therapy program, with more than 20 sessions intended for technologists, laboratory and medical directors, and quality assurance specialists. AABB is pleased to offer the newest in technology and networking opportunities dedicated to cellular therapy professionals — you won’t want to miss the meeting designed specifically with your needs in mind!