1. Monitoring Blood Supply Shortages The TRANS-Net Pilot Alan E. Williams, Ph.D. OBRR/CBER/FDA Blood Products Advisory Committee March 13, 2003

2. Blood Supply Overview 12,022,000 WB/RBC units transfused (92.5% of available) Available WB/RBC Margin 5.4% in 1997; 7.5% in 1999 Transfusion demand  ~ 4% yr. (Chemotherapy, Organ transplantation) 10.2% allogeneic WB/RBC supply growth 1997-99 Comprehensive Report on Blood Collection and Transfusion in the U.S. conducted by National Blood Data Resource Center (NBDRC) - Biennial survey – AABB members + hospital sample

3. Blood Supply Pressures Blood Donor base –~80% repeat donors (deferrals costly) –Changing demographic and other characteristics Aging –Fewer large worksite collections Elasticity of Supply –3-5 % maximum donation loss experience (1986 anti-HBc; 2000 ear/finger stick + UK deferral) –Limited supply during Summer and holidays (esp. 2002) Public responds to appeals - long term impact uncertain

4. Impact of Donor Travel Deferrals BSE/vCJD Deferrals – May and October ‘02 –Projected loss 5.0% nationwide –Actual loss not directly measurable –Major component of industry more restrictive Disproportionate impacts of travel deferrals –Coastal cities: 50%  donor loss (e.g. NYC and SF) –Rural US: 50%  impact –New York area “Euroblood” lost by pan-European deferral –Military bases –TSEAC requested supply monitoring and assessment

5. Blood Supply Oversight November, 1999 Amendment to DHHS Blood Action Plan “Monitoring and Increasing the Blood Supply” July, 2002 GAO Report - Blood Supply Generally Adequate Despite New Restrictions September 10, 2002 Hearing - House Subcommittee on Oversight and Investigations November 22, 2002 Hearing - New York State Assembly

6. September 5, 2002 HHS Advisory Committee for Blood Safety and Availability (ACBSA) DHHS should promote increased public awareness of the ongoing need for routine blood donations by healthy persons …….. DHHS should maintain and/or increase funded support for blood supply monitoring…….. DHHS should support initiatives to improve management of blood inventories ……

7. Blood Supply Monitoring What do we really need to know? Goal I: Monitor breadth, impact, and duration of blood and reagent shortages –Sensitivity to define regional and local shortages via data derived from entire population or large representative sample –“Real-time” data availability –Targeted to Group O RBCs and platelets –Shortage alerts derived from both blood collection centers and transfusion services –Trends, Characteristics ⇒ Prediction HHS Supply Monitoring, NBDRC Monthly sample, ABC Stoplight, ARC system inventory, TRANS-Net

8. Blood Supply Monitoring What do we really need to know? Goal II: Monitor long term blood collection and utilization trends –Total collections: WB and Components –Trends in component use –Monitoring of outdated products –Capacity for ad hoc collection of operational data –Data available to public –(Utilization – by ICD-9-CM code or similar) –(Updated annually) Center for Blood Research→ NBDRC Comprehensive Biennial Survey of Blood Collection and Utilization

9. Blood Supply Monitoring What do we really need to know? Goal III: Monitor blood center inventory at major collection facilities and reserve depots Continuous knowledge of inventory available for emergency distribution Early warning of impending shortage ABC Stoplight, ARC system inventory

10. Opportunities to Build an Improved Monitoring Network Sensitivity to local shortage National representation Real time Integration of blood center and transfusion service supply input. Prediction Data access

11. TRANS-Net Blood and Reagent Shortage Monitoring System Capt. Manette Niu, M.D. Sharyn Orton, Ph.D. Amy El Naggar Stanley Pawlowski Alan Williams, Ph.D. Voxiva Corporation Numerous colleagues – Advice and piloting

12. TRANS-Net: Design Characteristics (Consultation with twelve hospital transfusion services and blood centers) Simplicity –Utilize data routinely compiled by the facility –Daily (Mon-Fri) reporting with simple “no shortage” option to provide denominator –Recognize local variations in “shortage definition” –Telephone reporting option for sites without internet access Incentive for Participation –Rapid data availability –Meaningful use of collected data –Support for recruitment efforts

13. TRANS-Net: Design Characteristics (cont.) Population-based -All US blood centers and transfusion services (n= 5000+) will be eligible to participate. Brief registration form -Allows data verification, follow-up, tracking of site for consistent participation, an ensuring accurate reporting denominator Simple, automated data entry -Participants will be prompted for daily interaction with Trans-Net system via choice of E-mail/Web or touch-tone telephone. “No shortage” report made via single keystroke

14. A blood or blood component “shortage” definition may vary……….. – by hospital – by blood center – by geographic region – over time – based on supply network

15. Trans-Net: Data Management Electronic data received and mapped at central FDA monitoring site Registration of reporting facilities allows verification/ follow- up of selected reports Data access through software that considers geo-spatial density and frequency of shortage reports ALERT message generated at predetermined threshold

16. Trans-Net: Data Reporting Interactive public website –Data saved to an Oracle database –GIS mapping software provides public view of “real time” color-coded maps reflecting regional and national blood supplies –“Drill down” capability to n  5 respondents

22. 2003 Holiday Blood Shortage Two mid-week holidays Blood shortage recognized broadly 1/3/03 Appeals –HHS Secretary Thompson –AABB/ABC/ARC Prolonged recovery “Blizzard” of 2003 (Scheduled start of TRANS-Net pilot 1/6/03)

23. No. of sites reporting shortages to TRANS-Net, by “weighted” shortage criteria, 1/6 – 2/14/03

24. Transfusion Service and Blood Center “Weight” and No. of Site Reporting Shortage, TRANS-Net (1/6/03-2/14/03)

25. Characteristics of post-holiday blood supply 1/6/03 - 2/19/03 54/148 (36%) transfusion service shortage days Pre- 1/6 to 2/10 Sooner recovery than blood centers 75/142 (53%) blood center shortage days Pre - 1/6 to now Blood center shortage reports continue Blood Centers - more sensitive monitor Transfusion Services - reflect acute need

26. TRANS-Net Future Phase I - Pilot (nine sites) 1/6/03 – 2/28/03 Discussion within HHS/OMB Review Phase II - Roll-out to several hundred participants –Monitoring at regional level –Functional mapping Phase III- Full population of 145 blood centers and 5000+ transfusion services Other uses: blood center inventory, platelet supply, adverse event reporting, supply/reagent shortage, electronic blood product request, public blood “thermometer”