Monitoring the Blood Supply What do we really need to know

1
Monitoring the Blood Supply What do we really
need to know?

• Alan E. Williams, Ph.D.
• OBRR/CBER/FDA
• TSE Advisory Committee
• February 20, 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

17
(No Transcript)
18
(No Transcript)
19
(No Transcript)
20
(No Transcript)
21
(No Transcript)
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