# Presentation: 220769

## 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

## 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

## 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

## 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

## 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

## 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 ......

## 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*

## 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*

## 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*

## 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

## 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

## 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

## 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

## A blood or blood component “shortage” definition may vary...........

-  by hospital
-  by blood center
-  by geographic region
-  over time
-  based on supply network

## 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

## 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

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## 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)

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

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

## 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 *

## 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”