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Testing for Communicable Diseases: 21CFR Part 610

The critical elements of Part 610 General Biological Products Standards relate to testing for communicable disease agents. Note that only the following tests are currently required, although additional testing (eg, Chagas and West Nile Virus) may be routinely performed. Donors are tested for the diseases listed in the product circular.
  • HIV types 1 and 2
  • Hepatitis B virus
  • Hepatitis C virus
  • Human T-lymphotropic virus types 1 and 2
  • Syphilis
Although this section is generally not applicable to transfusion services, it may be valuable to review the regulations as physicians and nurses may want to know what testing is performed on the donor blood.
It is expected that each donation is tested before release. However, there are exceptions for dedicated donors where multiple donations are expected and the donor may be tested within 30 days of the donation. Special labeling is required when the donation has not been tested, such as when autologous donations are collected. The name and identification of the intended recipient must be on the label or tie tag.
Units may be shipped before testing is complete, only if there is a medical emergency and testing will be performed and reported to the receiving facility.
Note that if your laboratory allows any autologous donation to be used for allogeneic transfusion, you must assure that all autologous donations are tested under this section. Labels that are appropriate for each donor testing status (eg, untested, tests negative, reactive on current collection) are listed in section 610.40.