Title: Section 58-2.11 - Records to be kept when blood is collected for autogeneic or allogeneic transfusion

Effective Date

09/27/2015

58-2.11 Records to be kept when blood is collected for autogeneic or allogeneic transfusion.

(a) Every blood bank shall maintain records of each container of blood or blood components collected or prepared therein. The records shall contain the following information:

(1) donor's full name, address, age, sex and identifying code;

(2) date and amount of blood collected;

(3) any adverse reaction of the donor;

(4) signature of or other unique identifier provided by the phlebotomist;

(5) results of all tests performed on a sample from the donor or a unit;

(6) disposition of the blood or blood components;

(7) for autogeneic donation, documentation of written or verbal consent of the donor-patient's health care provider if donation takes place prior to anticipated surgery or medical procedure, of the physician responsible for collection or his/her designee, and of the donor-patient. If the blood is to be considered for allogeneic use, the donor shall sign a consent form giving consent for such use, specifying procedures for release of the unit by the health care provider, and stating that to the best of the donor’s knowledge, the blood is safe for use by others; and

(8) if a donor is determined to be unsuitable for donation based on donor history, laboratory test results or implication in a case of transfusion-transmitted disease according to the protocol of the blood collection service, a record of the donor's name and identifying information. Blood from such a donor shall not be released, even if results of testing on subsequent donations are negative, unless the donor has been approved for reentry into the donor pool by the director of the blood bank or designee who is a physician .
 

Volume

VOLUME A-1 (Title 10)

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