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Autologous Labeling

This additional information must appear on the label for blood and blood components intended for autologous transfusion:
  • Information adequately identifying the patient, eg, name, date of birth, hospital, and identification number
  • Date of donation
  • The statement: "AUTOLOGOUS DONOR"
  • The ABO and Rh blood group and type, except as provided in paragraph (c)(9) of section 606.121.

Each container of blood and blood component intended for autologous use and obtained from a donor who fails to meet any of the donor suitability requirements under 640.3 or who is reactive to or positive for one or more tests for evidence of infection due to communicable disease agents under 610.40 of this chapter must be prominently and permanently labeled "FOR AUTOLOGOUS USE ONLY" and as otherwise required under 610.40 of this chapter. Such units also may have the ABO and Rh blood group and type on the label.

Units of blood and blood components originally intended for autologous use, except those labeled as prescribed under paragraph (i)(5) of this section, may be issued for allogeneic transfusion provided the container label complies with all applicable provisions of paragraphs (b) through (e) of this section. In such case, the special label required under paragraphs (i)(1), (i)(2), and (i)(3) of this section must be removed or otherwise obscured.

A tie-tag attached to the container may be used for providing the information required by paragraphs (e)(1)(iii), (e)(2)(ii), and (e)(3), (h), or (i)(1), (i)(2), and (i)(3) of this section.