Ensure an adequate supply of high quality blood and blood products are available to all health care facilities and military operational areas during peacetime, and mobilization
What is The Service Blood Program Office (SBPO) mission
100
enforces regulations to ensure the Safety and efficacy of biologics and drugs produced and devices that include blood/components and diagnostic reagents used or manufactured
What is the FDA
100
Advances the practice and standards of transfusion medicine and cellular therapies to optimize patient and donor care and safety
What is the Mission of the AABB
100
is a Lab Information System (LIS) designed to ensure highest quality blood products
What is DBSS
200
Manage the Department of Defense Blood Program; implements standardization between branches of the military; coordinates mobilization operations
Ensure continued product safety and quality
Emphasize preventing errors rather than detecting them retrospectively
What is the mission of the ASBPO
200
The USNS Mercy and the USNS Comfort
What is Auxiliary Hospital Ship (T-AH)
200
Comprehensive directive found specifically in CFR 21 parts 210 and 211
Sets specific Quality Control requirements
What is Good Manufacturing Practice (GMP)
200
the pursuit of excellence
focus on the patient and donor
integrity
transparency
consensus building
innovation
What AABB Core Values
200
Blood Program Management and Operations
What is a Peace time Requirement
300
Recommended increased use and stockpiling of frozen RBC’s: in frozen blood depots; in fixed and field facilities; and, aboard ships
What is an Objective of The Military Blood Program?
300
Provide coordination and management of all commands where blood products are processed, stored, or used
What is the role of the SBPO
300
The “legal arm” that mandates adherence to current Good Manufacturing Practices by following the guidance detailed in written Standard Operating Procedures (SOP). These are US Code and not a specific entitiy. This gives the FDA the power to impose sanctions on an entity or facilty.
What is the Code of Federal Regulations (CFR)
300
AABB Code of Ethics and AABB Bylaws
AABB Firewall Policy
AABB Patient and Donor Safety Center Firewall Policy
AABB Policy on Conflicts of Interest and Confidentiality
AABB Trademark Usage Guidelines
What are guidelines and policies
300
It is used to support the Armed Services Blood Program.
What is DBSS
400
Contingency warehouse
Confirms Blood Groups and Types, Product Labels
Ships Blood Products to Unified Commands
7,200 units per day
Contingency storage
Keeps mostly type O (Universal Donor) on the shelves
What is the function of the ASWBPL?
400
Maintain rapid expansion capabilities to collect, process, and ship blood products for mobilization military forces support
What is Mission of the SBPO
400
License suspension or revocation
Warning letters
Seizure
Injunctions
Prosecution and consent decree
What are administrative and legal sanctions of the FDA
400
Supports AABB in developing positions and communicating with congressional offices on legislative issues facing the transfusion medicine and cellular therapies community. This department monitors and reports on such federal legislative issues in AABB News and AABB Weekly Report
What is the Legislative Program
400
• Military Treatment Facilities (MTF)
Blood Donor Centers
Mobile Blood Donor Facilities
Armed Services Whole Blood Processing Laboratories (ASWBPL)
Blood Supply Units or Blood Support Detachments
Blood Transshipment Centers
What are examples of DBBS users
500
Collects 120,000 units of blood from military, family members, and DoD civilians annually
What is the DOD
500
SBPO
What is Services Blood Program Offices
500
Issues federal licenses for the establishments and the biologic product they manufacture
What is The Center for Biologics, Evaluation, and Research (CBER
500
is an international, not-for-profit association representing individuals and institutions involved in the field of transfusion medicine and cellular therapies. The association is committed to improving health by developing and delivering standards, accreditation and educational programs that focus on optimizing patient and donor care and safety
What is AABB
500
Track the movement of blood from CONUS to theater of operation.
Record (document) the receipt and shipment of blood.
Track the transfusion of blood products.