Can non-licensed donor phlebotomists collect apheresis blood products?

A question was raised regarding the appropriateness of using non-licensed staff for blood donor phlebotomy. The following response is based on input from various blood banking experts in California, and does not represent an official position of the CBBS.

It has been reported that the California State Department of Health Services interprets Section 1607 of the California Health and Safety Code to allow blood donor phlebotomists, as defined by the American Association of Blood Banks, to collect apheresis blood products from healthy blood donors.

Section 1607 of the Calif. Code reads as follows:

1607. (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.

(e) Nothing in this chapter shall prohibit the collection of blood at a state institution, a blood bank licensed pursuant to this chapter, or other establishment, under conditions established and acceptable to the department, by the personnel of the collecting entity.

(f) A staff position for a blood donor phlebotomist created as a consequence of this section shall not be the only cause for the displacement of any licensed personnel employed in a licensed blood bank as of the effective date of the statute amending this section during the 1995-96 Regular Legislative Session. As used in this section, the term "displacement" shall mean a reduction in hours of non overtime work, the loss of wages, or the loss of employment.

(g) Nothing in this section shall be construed to limit the rights of employees or employee organizations to bargain in good faith on matters of wages, hours, or other terms and conditions of employment, including the negotiation of workplace standards within the scope of collective bargaining as authorized by state and federal law.

Based on the above, it appears that phlebotomists (even non-licensed ones) who meet the requirements of Section 1607 may collect units from volunteer whole blood donors or from apheresis blood donors provided apheresis units are collected into closed, automated systems and the apheresis procedures are done under direct supervision by a licensed person. Direct supervision is generally interpreted to mean "line of sight" supervision, not just having someone in the building. When dealing with patients (as opposed to blood donors) autologous and therapeutic phlebotomy may only be performed by licensedstaff. The State also requires that phlebotomists be certified by the State annually for a fee of $25. The training is substantial and must be obtained through a State-approved national accrediting organization.

If you feel this information is incorrect or misleading, please let me know, and I will share your concerns with the entire CBBS e-network.

The following was submitted by an e-network member, in response to the above discussion.

ADDENDA March 23, 2000

1. "The only question/concern I have is about the accreditation of phlebotomists through the state. I would suggest you talk to Karen Nichols at the Department of Laboratory Field Services. I was on a committee a couple of years ago that created the curriculum requirements for phlebotomy training programs. Blood donor phlebotomists had very different requirements from hospital phlebotomists, as one would expect. Hospital phlebotomists need to know when to collect the rainbow of tube types; blood donor phlebotomists need to know how to interview a donor. When the emergency legislation finally went through on hospital phlebotomists, it did not include the requirements for blood donor phlebotomists. My understanding from Karen is that there are currently no requirements for blood donor phlebotomists. The law states that such phlebotomists must meet AABB certification requirements, but these no longer exist since AABB discontinued its phlebotomist certification program. It seems we are somewhat in a state of limbo for blood donor phlebotomists. But please, check with Karen (510-873-6360) to verify this information. Things do seem to change quickly, and this information is several months old."

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