Regulatory agencies

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.

The blood center also is also a member of and accredited by AABB.

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.

Impact of Ebola on blood safety?

  • Transmission of Ebola virus by blood transfusion has never been seen. Individuals in the US who were potentially infected in Africa are already deferred from donating blood for at least one year because of their potential exposure to malaria in all the affected west Africa countries.
  • Individuals exhibiting signs or symptoms of Ebola are also ineligible to donate.
  • Under recommendations from AABB, contacts of patients with or suspected to have Ebola infection identified by public health authorities are being asked to refrain from donating blood. Even though asymptomatic Ebola viremia has been demonstrated, blood centers are taking the extra precaution of providing information to presenting donors stating that individuals who have been identified by public health authorities as possible contacts of Ebola patients should refrain from donating until 28 days or more after their last possible direct contact with the infected person.

For the most current information regarding Ebola, please visit the CDC’s website.