Authorized by 42 U.S.C. 282(b)(16), Section 402(b)(16) of the Public Health Services Act, as amended. The National Institutes of Health (NIH) Clinical Center Research Hospital Board (Board) is governed by the provisions of the Federal Advisory Committee Act, as amended (5 U.S.C. app.), which sets forth standards for the formation and use of advisory committees.
Objectives and Scope of Activities
The objective of the Board is to provide advice and recommendations to the NIH Director and CEO of the NIH Clinical Center pertinent to maintaining excellence in hospital operations, safety and quality, regulatory compliance, clinical research, and hospital leadership performance oversight. The Board's advice and recommendations may regard issues, processes, studies, and/or reports on a range of topics in relation to the NIH Clinical Center and the Chief Executive Officer's (CEO) duties and authorities.
Description of Duties
The purpose of the Board is to provide advice and recommendations to the NIH Director on the NIH Clinical Center's policies and procedures regarding hospital operations, safety and quality, and regulatory compliance. Using leading institutions in health care and research as benchmarks, the Board will provide advice in the following areas:
Management, quality and safety, and compliance of hospital operations
Policies and organizational approaches that promote quality and safety
Risk areas that need to be addressed by hospital and agency leadership
Implementation of policies and strategic plans
Requirements for hospital leadership
Performance of the CEO including evaluation based on operating plans and quality metrics
The Board may request reports on quality and safety measures, risk assessment, violations and remediation measures/corrective action plans, and additional measures. Unlike hospital boards in the community, the Board does not have financial authority.
The duties of the Board are solely advisory and shall extend only to the submission of advice and recommendations to the NIH Director and CEO of the NIH Clinical Center, which will be non-binding to the NIH. No determination of fact or policy will be made by the Board.
Agency or Official to Whom the Committee Reports
The Board will advise, assist, consult with, and make recommendations to the NIH Director and CEO of the NIH Clinical Center.
Management and support services will be provided by the Office of the Director, NIH. Additional support, including access to information, reports, and records, is required for the Board's activities to the extent permitted by law and subject to the availability of resources.
Estimated Annual Operating Costs and Staff Years
The estimated annual cost for operating the Board, including compensation and travel expenses for members, but excluding staff, is $83,205. The estimated annual person-years of staff support required is 0.3 at an estimated annual cost of $42,728.
Members shall not be paid for their time or service. As for persons intermittently in the government service, members shall be reimbursed for their travel-related expenses to attend meetings in accordance with 5 U.S.C. § 5703.
Designated Federal Official
The NIH Director will assign a full-time or permanent part-time employee to serve as the Designated Federal Official (DFO) of the Board. In the event that the DFO cannot fulfill the assigned duties of the committee, one or more full-time or permanent part-time NIH employees will be assigned as DFO and carry out these duties on a temporary basis.
The DFO will approve all of the Board's and subcommittees' meetings, prepare and approve all meeting agendas, attend all Board and subcommittee meetings, adjourn any meeting when it is determined to be in the public interest, and chair meetings when directed to do so by the Director, NIH.
Estimated Number and Frequency of Meetings
Meetings of the full Board will be held approximately three times within a fiscal year. Meetings will be open to the public except as determined otherwise by the Secretary, Department of Health and Human Services (Secretary) in accordance with subsection (c) of section 552b of Title 5 U.S.C. Notice of all meetings will be given to the public. In the event a portion of a meeting is closed to the public, as determined by the Secretary, in accordance with the Government in the Sunshine Act (5 U.S.C. 552b(c)) and the Federal Advisory Committee Act, a report will be prepared which will contain, as minimum, a list of members and their business addresses, the Board's functions, dates and places of meetings, and summary of the Board's activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.
Unless renewed by appropriate action, the NIH Clinical Center Research Hospital Board will terminate two years from the date the charter is filed.
Membership and Designation
The Board will consist of a Chair, including, up to 14 non-federal members, appointed by the NIH Director. The appointed members will consist of authorities who are nationally recognized leaders in sectors related to the NIH Clinical Center's duties and authorities, including but not limited to research hospital administration/operations, clinical care, safety and quality, clinical and research compliance, or clinical research. Non-federal members will be selected from the academic and private sector research community, as well as the general public. Non-federal members must be eligible to serve as Special Government Employees (SGEs) and will serve as SGEs.
The Board will not include Federal members who are not employees of the Department of Health and Human Services. HHS Federal members will be allowed to serve as ex-officios. Members will be invited to serve for overlapping terms of up to four years. A member may serve after the expiration of that member's term until a successor has taken office. A quorum for the conduct of business by the full Board will consist of a majority of currently appointed members.
As necessary, subcommittees and ad hoc working groups may be established by the DFO within the Board's jurisdiction. The advice/recommendations of a subcommittee/working group must be deliberated by the parent advisory committee, which is the Board. A subcommittee/working group may not report to a Federal official unless there is statutory authority to do so.
Subcommittee membership may be drawn in whole or in part from the parent advisory committee. All subcommittee members may vote on subcommittee actions and all subcommittee members count towards the quorum for a subcommittee meeting. Ad hoc consultants are not members, do not count towards the quorum, and may not vote. A quorum for a subcommittee will be three members. The Department Committee Management Officer will be notified upon establishment of each standing subcommittee and will be provided information on its name, membership, function, and estimated frequency of meetings.
Meetings of the committee and its subcommittees will be conducted according to the Federal Advisory Committee Act, other applicable laws and Departmental policies. Committee and subcommittee records will be handled in accordance with General Records Schedule 6.2, Federal Advisory Committee Records, or other approved agency records disposition schedule. These records will be available for public inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.