A California colleague asks what categories of personnel are being assigned to perform therapeutic phlebotomies. He also asks what categories of personnel are being assigned to perform autologous and directed donations. His center is updating their SOPs and would like to know what practices currently exist in the community.

Editors' note: According to section 1607 of the California HEALTH AND SAFETY CODE

(a) Notwithstanding any other provision of law, licensed clinical laboratory bioanalysts, licensed clinical laboratory technologists, registered clinical laboratory technologist trainees, licensed vocational nurses, registered nurses, and blood donor phlebotomists, as defined by the American Association of Blood Banks, may perform skin puncture and venipuncture for the purposes of collecting human blood if both of the following are satisfied:

(1) The acts are performed in a blood bank licensed pursuant to this chapter and personnel training and standards meet accreditation requirements of the American Association of Blood Banks.

(2) The acts are performed under the direct and responsible supervision of a licensed physician and surgeon. The licensing and registration referred to in this section shall be licensing and registration pursuant to the Business and Professions Code.

(b) In accordance with the American Association of Blood Banks standards, the medical director of the blood bank shall be responsible for all medical and technical policies and procedures that relate to the safety of staff members, donors, and patients, including, but not limited to, ensuring that the blood bank has a qualified and competent staff to perform all tasks involved in the collection, storage, processing, and distribution of blood and blood components. The employer blood bank shall be responsible for determining the appropriate mix of qualified, competent employees that meets the accreditation requirements of the American Association of Blood Banks and is consistent with the services rendered.

(c) Personnel who are explicitly authorized by the blood bank and who meet the education, training, and competency standards of the blood bank, may obtain a predonation medical history and perform predonation screening. When unlicensed personnel perform these duties, the review of work required by federal regulations relating to good manufacturing practices, as set forth in Part 211 and Part 606 of Title 21 of the Code of Federal Regulations, shall be performed by those staff members who are licensed health care personnel.

(d) The collection of blood from autologous patients and other individuals who do not meet the American Association of Blood Banks criteria for regular volunteer donation shall be conducted by licensed health care personnel.

Since autologous and some directed donations do not meet AABB criteria for regular donation (and are not regular volunteer donors, but are being drawn pursuant to a physician’s order), one might conclude that such collections shall be done by appropriately licensed health care personnel.

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator