PURPOSE
The Blood, Organ, and Tissue Senior Executive Council (BOTSEC) (formerly the PHS Blood Safety Committee) shall serve as the Department's internal executive leadership coordination mechanism across HHS organizational components involved in blood, organ, and tissue safety and blood product availability.
AUTHORIZATION
In 1995 the Institute of Medicine (IOM) published a comprehensive report on Human Immunodeficiency Virus (HIV) and the blood supply. The IOM report addressed the process of decision-making including federal involvement in ensuring the safety and availability of the blood supply. An internal task force of senior Public Health Service (PHS) leadership made the following recommendations based on the IOM report. Based on these recommendations, HHS established the Blood Safety Committee, and the Assistant Secretary for Health was designate to function as the HHS Blood Safety Director.
OBJECTIVES AND GOALS
The BOTSEC is an advisory forum for senior leadership of HHS organizational components. The Council identifies and recommends actions on emerging issues, proposed policies, public health threats, and issues related to the blood, organ, and tissue safety and availability.
The BOTSEC will establish and implement a strategic plan for maintaining and enhancing blood, organ, and tissue safety and availability (e.g. establish a national biovigilance system, promote disaster preparedness, increase donor recruitment and retention, develop priorities for research, provide risk assessments and rick communication, etc.)
DUTIES
The BOTSEC is charged to perform the following tasks; other specific tasks will be added, as it becomes necessary:
- Inform and recommend to the Chair and its members recent, current, and future OPDIV/STAFFDIV priorities, decisions, and actions on public health issues relevant to blood, organ, and tissue safety and availability.
- Identify common issues and approaches and pursue opportunities for coordinated action, e.g. data and survey system approaches, emerging infectious diseases, risk communication, etc.
- Carefully examine, for coordination purposes, appropriate policy or program action that requires or may require a HHS position on an issue.
- Propose and discuss topics or questions to be addressed by the following federal advisory committees for which the Department provides management support: the Advisory Committee on Blood and Tissue Safety and Availability, Advisory Committee on Organ Transplantation, and Advisory Committee on Blood Stem Cell Transplantation; coordinate and support a collective response to Committee recommendations.
- Develop strategies to alert scientists, industry, and academia about the needs and opportunities for research to maximize the safety and availability of blood, organs, and tissues.
- Identify lead OPDIV/STAFFDIVs to develop strategies and obtain resources to ensure the education of public health officials, clinicians, and the public about the nature of public health threats and strategies for dealing with these threats.
MEMBERSHIP AND DESIGNATION
Membership on the BOTSEC includes senior leadership or a designee from the following HHS organizational components:
- Office of the Assistant Secretary for Health (OASH)
- Office of the Assistant Secretary for Preparedness and Response (ASPR)
- Office of the Assistant Secretary for Planning and Evaluation (ASPE)
- Agency for Healthcare Research and Quality (AHRQ)
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare and Medicaid Services (CMS)
- Food and Drug Administration (FDA)
- Health Resources and Services Administration (HRSA)
- National Institutes for Health (NIH)
The Council structure will include liaison representation from the Office of the Assistant Secretary of Defense (Health Affairs) in the Department of Defense (DoD) and the Veterans’ Health Administration in the Department of Veterans Affairs (VA). Representatives from the HHS organizational components will have voting privileges. The liaison representatives will not have voting privileges.
The ASH, functioning as the HHS Blood Safety Director, will serve as the Council Chair. The OASH Senior Advisor for Blood and Tissue Policy will serve as the BOTSEC Executive Director.
ESTIMATED NUMBER AND FREQUENCY OF MEETINGS
It is planned that the BOTSEC will meet at least once a year; additional meetings will be scheduled as needed. The Executive Director will schedule and coordinate all meetings of the BOTSEC in consultation with the Committee Chair. The Executive Director will collaborate with the Council Chair and representatives of the participating agencies to develop agenda items for BOTSEC meetings.
Summaries of the BOTSEC meetings will be developed; the summaries will include, at a minimum, participant lists, any action items discussed, and any decisions reached and/or recommendations developed that will be forwarded to the respective senior leadership official for consideration.
SUBCOMMITTEES
The PHS Blood, Organ and Tissue Safety (PHS BOTS) working group will be established to provide assistance for BOTSEC to accomplish its mission. The membership for the PHS BOTS will consist of representatives from OASH, AHRQ, CDC, CMS, FDA, HRSA, NIH, DoD, and VA. Each of the designated agencies will provide a representative who has expertise in blood, organ, and tissue safety and blood product availability issues.
The PHS BOTS will consider issues in accordance with the charge given to BOTSEC. The PHS BOTS will make reports to the BOTSEC. Any sub-working groups of the PHS BOTS will report to BOTSEC through the PHS BOTS.
SUPPORT
Management support for BOTSEC will be provided within OASH by the Office of Infectious Disease and HIV/AIDS Policy.
DURATION
It is expected that BOTSEC will continue to operate until it is determined that there is no need for the prescribed services that the Council was established to perform. However, some action should be taken every five years to review and renew the charter to allow for any necessary amendments to be made. Amendments to the charter can be made at other times, as well, when a need to do it is identified.
APPROVED
January 21, 2020
ADM Brett P. Giroir, MD
Assistant Secretary for Health
