# Presentation: 207878

## Advisory Committee on Blood Safety and Availability
August 2006

Jerry A. Holmberg, Ph.D.

- August 2006
- Jerry A. Holmberg, Ph.D.

**Notes:**
Scope

## Definition

- What are the essential components or basic elements of a biovigilance system?
- Should biovigilance be considered part of a comprehensive quality standard as expressed in cGMP, cGTP, or CLIA?
- What characteristics of a biovigilance system are already in place within the United States?

## Impact

- Does the US need a biovigilance system to ensure blood safety and availability?
- What would be the Strength, Weakness, Opportunity and Threat (SWOT) of a biovigilance system?
- How would a biovigilance system contribute to, and integrate with the transformation of the health care system within the United States?
- Should a biovigilance system integrate with international systems, either planned or currently in existence?
- In the above question, what does integrate mean to the Committee?
- Standardized definitions?
- Standardized data elements?
- Standardized platforms?
- Data sharing?
- Analysis?
- Forum to discuss analysis?

## Responsibility

- What is the role of the federal government and the private sector in a biovigilance system?
- What recommendation(s) does (do) the Committee have in regards to the government’s role and function in the development, operation and support of a national biovigilance system?

## Recommendation

- The safety of the US blood supply is a principal activity of the Advisory Committee on Blood Safety and Availability, and inclusion of efforts to improve organ and other tissue safety and availability also need to be considered, we recommend that the Secretary coordinate Federal actions and programs to support and facilitate biovigilance in partnership with initiatives in the private sector.

## Recommendation

- “Biovigilance” is defined as a comprehensive and integrated national patient safety program to collect,  analyze and report on the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, cells, tissues, and organs.  The program should be outcome driven with the objectives of providing early warning systems of safety issues, exchanging of safety information, and promoting education and the application of evidence for practice improvement.

## Recommendation

- Formation of a HHS and PHS Biovigilance Task Group would be an important step for identification of the vision, goals, and processes needed to advance these objectives.
- The PHS task group should produce an analysis and operational proposal concurrently with the AABB Inter-organizational Task Force on Biovigilance and other private sector efforts to include:
- A **gap analysis** regarding the effectiveness of the current activities;
- The **need for mandatory versus non-mandatory**, and regulatory versus non-regulatory reporting;
- The **scope of reporting** with regard to product problems, medical errors and clinical adverse events including recognized and novel events;
**Database centralization** versus data sharing;
**Database governance**, ownership and accessibility;
**Format and standards for data reporting including confidentiality**;
- Potential for **coordination with non-U.S. safety** reporting systems;
**Funding** mechanisms for a sustainable system; and,
**Design and feasibility of suitable pilot programs** to determine the characteristics of a value-added system.

**Notes:**
This Task Group should participate with private sector efforts, including the AABB Inter-organizational Task Force on Biovigilance, to advance public health in this effort.

## Action 

- ACBSA Charter revised and renewed.
- Expand scope to transfusion and transplantation safety
- Expanded government (non-voting)
- CBER Office of Cell, Tissue and Gene Therapy
- HRSA, Department of Transplantation
- Working group formed within HHS OPDIVs to develop gap analysis
- Dr. Kuehnert, CDC
- Dr. Goldsmith, FDA