|
Cascade Regional Blood Services is subject to regulation by a number of federal agencies including:
- Food and Drug Administration (FDA)
- Nuclear Regulatory Commission (NRC)
- Occupational Health and Safety Administration (OSHA)
- Washington Industrial Safety and Health Act (WISHA)
- Clinical Laboratory Improvement Amendments (CLIA) under the Health Care Finance Administration (HCFA)
Title 21, Chapter 1 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 order to ship blood and components interstate, a blood establishment must be licensed by the FDA. A separate license amendment is required for each fixed or mobile facility used in collection and/or processing of blood components. CRBS currently has three licensed fixed blood collection and /or processing sites and six licensed mobile units that are used for blood collection. In addition, each component prepared must be licensed by the FDA if it is shipped interstate. The blood center is inspected by the FDA to ensure compliance with regulations.
Because CRBS maintains a blood irradiator, a NRC license is required. Washington State conducts periodic inspections of licensed facilities.
In compliance with OSHA/WISHA regulations, CRBS must provide a safe environment for personnel as well as for donors and others visiting its facilities. In addition, personnel must be informed of their right to know about potential hazards encountered on the job and must be provided appropriate training and personal protective equipment to assure their safety.
CLIA accreditation, which is administered through HCFA, is required for all laboratories performing diagnostic tests. HCFA performs periodic inspections of accredited facilities. HCFA accepts the results of the AABB inspections.
The blood center also is subject to oversight by private accrediting agencies including:
The 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 annually. 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 CAP accreditation, we do participate in relevant CAP proficiency testing programs that meet CLIA requirements.
|
