Governing Bodies

The Blood Bank is a high regulated industry that is monitored and inspected by many different organizations.

Regulatory Agencies:
    These agencies enforce Federal Law and can shut down a hospital or lab if these regulations are violated.

       Food & Drug Administration (FDA)
          Provide Code of Federal Regulations (CFR) that are rules written and enforced by the Federal Government
          Provide current Good Manufacturing Practices (cGMP) which gives guidance on production of drugs and biologics to ensure safety, purity, and potency.
          The FDA can inspect any facility unannounced.

      Centers for Medicare & Medicaid Services (CMS)
          Provide CMS regulations for the protection of patients and donors, which includes Civil Rights and Privacy Laws related to health care and research.
        
Accrediting Agencies:
      These agencies set standards that must be met by the hospital or lab to attain and maintain accreditation. These agencies do routine unannounced inspections of accreditated facilities.

           Joint Commission on Accreditation Of Healthcare Organizations (JCAHO)
           College of American Pathologists (CAP)
          Advancing Transfusion and Cellular Therapies Worldwide  (AABB)

Laboratory Specific Laws:
      Clinical Laboratory Improvement Act of 1988 (CLIA '88), in 1988 the Congress decided that their needed to regulate all the labs in the US. Explanation of CLIA '88 .
   
Other agencies that regulate the Blood Bank:  

      Occupational Health & Safety Administration (OSHA)
          Provides and enforces regulations to provide safe and healthful working conditions.
                They require employers to provide safety training of personnel,  personal protective equipment (PPE), vaccinations, and follow-up care for any exposures to hazardous material.

     Department of Transportation (DOT)
          U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration (PHMSA) provides a guidance document to ensure safe shipping of blood products.
      
      Nuclear Regulatory Commission (NRC) regulates how nuclear material is used in the U.S. and how it is protected from misuse. Hospitals, Blood Banks, and Donor Centers having access to radioactive material for manipulation of Blood Products must follow these regulations.