# Presentation: 399615

## Implementation of Blood Action Plan

**Mary Gustafson**
**OBRR, CBER, FDA**
**PHS ACBSA, January 27, 2000**

**Initiatives to Promote Blood Availability**

## PHS Task Group Recommendations for Increasing the Blood Supply

**Mary Gustafson**
**OBRR, CBER, FDA**
**PHS ACBSA, August 26, 1999**

## Strategies for Increasing the U.S. Blood Supply	

**Recommendations from PHS Task Group - August 1999**
**Recommendations Incorporated Into Blood Action Plan - November 1999**

**Notes:**
Report on blood supply requested by Dr. David Satcher following National Blood Data Resource Center (NBDRC) Survey comparing 1997 an 1994 data
     - NBDRC projected that demand will overtake supply in 2000
     - ad hoc interagency task group convened
     - Report from task group presented to Dr. Satcher in August 1999
     - Recommendations Incorporated Into Blood Action Plan (BAP) in November 1999

## Blood Action PlanMonitoring and Increasing the Blood Supply

**1.  Monitor the Blood Supply**
**2.  Encourage More Donations by Eligible Donors**
**3.  Improve Donor Relations as Part of Recruitment and Retention**
**4.  Remove Restrictions to Safe Donation**
**5.  Address Economic Issues Facing the Blood Industry**

**Notes:**
The Blood Action Plan issue area entitled "Monitoring and Increasing the Blood Supply" has five task areas listed on the slide

## Monitor the Blood Supply

**1.  NHLBI, on December 10, contracted with NBDRC to conduct monthly surveys.**
**2.  By October 2001, PHS will determine long-term responsibility.**

**Notes:**
- Problem in forecasting blood supply - no ongoing national effort

- NIH's NHLBI will fund the NBDRC to perform monthly surveys for up to 3 years

- A decision on whether the PHS should maintain a program for surveillance will be addressed by 10/1/01

## Encourage More Donations by Eligible Donors

**1.  DHHS offered support to industry to participate in PSA’s.**
**2.  NHLBI sponsoring Feb. 28 workshop, “National Strategy to Increase Blood Donations.”**
**3.  FDA to publish donor incentive guidance by June 30, 2000.**
**4.  NHLBI to explore feasibility of educational programs by June 30, 2000.**

**Notes:**
- DHHS is cooperating with the private sector on PSA's

- NHLBI will support evaluation of blood donor incentive models to encourage donations through workshops and studies

- FDA will publish guidance on currently acceptable incentives

- NHLBI will explore feasibility of initiating studies on development of educational programs to encourage blood donations as a civic responsibility

## Improve Donor Relations as Part of Recruitment and Retention

**1.  FDA draft guidance on recruitment practices by December 31, 2000.**
**2.  Possible FDA/NHLBI donor recruitment workshop by August 30, 2000.**
**3.  FDA guidance on computer interviews by September 30, 2000.**
**4.  Initiate simplification/abbreviation of donor questionnaire by January 1, 2001.**

**Notes:**
FDA will issue guidances on use of the computer in donor interviewing and donor recruitment practices

FDA and NHLBI will co-sponsor a public workshop, if needed, to develop "best practices" in donor recruitment

FDA will coordinate a joint government/industry initiative to simplify the donor history questionaire

## Remove Restrictions to Safe Donation

**1.  FDA to issue guidance for use of therapeutic hemochromatosis donations by May 31, 2000.**
**2.  CDC/FDA workshops to be planned as warranted.**

_**Remove Restrictions to Safe Donation**_

**Notes:**
FDA will issue guidance on how to obtain a case-by-case exemption to collect blood from persons with hemochromatosis without special "disease state" labeling

As funding permits, CDC and FDA will co-sponsor workshops to explore policy changes with respect to donor suitability criteria, test requirements and re-entry of donors previously found unsuitable.  Candidate areas to explore are male/male sex deferrals and test/re-entry for positive anti-HBc

## Address Economic Issues Facing the Blood Industry

**2.  April 2000 PHS AC BSA to discuss reimbursement issues.**
**3.  DHHS will clarify policies on reimbursement by June 1, 2000.**

_**Address Economic Issues Facing the Blood Industry**_

**Notes:**
The August 1999 PHS AC on Blood Safety and Availability provided a public forum for discussing potential safety measures that have significant cost implications
     - DHHS will work with its agencies to review government policies affecting reimbursement and will clarify its policies on reimbursement for blood services by June 1, 2000