Cascade Regional Blood Services is subject to regulation by a number of federal agencies including:

  • Food and Drug Administration
  • Occupational Health and Safety Administration
  • Washington Industrial Safety and Health Act
  • Clinical Laboratory Improvement Amendments under the Health Care Finance Administration
  • Title 21, series of the Code of Federal Regulations (CFR) contains regulations pertaining to blood collection, processing, storage and distribution operations. The federal agency regulating blood collection and processing activities is the FDA.
  • In compliance with OSHA/WISHA regulations, CRBS must provide a safe environment for personnel as well as for donors and others visiting its facilities.
  • CLIA accreditation, which is administered through HCFA, is required for all laboratories performing diagnostic tests. HCFA performs periodic inspections of accredited facilities.



AABB is the primary standard setting and accreditation organization for blood collection, processing, distribution and transfusion activities. AABB publishes Standards for Blood Banks and Transfusion Services, which is updated every two years. These provide detailed requirements for donor suitability, component preparation, testing, labeling, storage and distribution of blood components. The AABB standards are compatible with the CFR requirements but are updated more frequently and provide more specific details. AABB inspects accredited blood centers every two years to ensure compliance with standards.

Although the blood center does not maintain College of American Pathologists accreditation, we do participate in relevant CAP proficiency testing programs that meet CLIA requirements.