Bill Text: CA SB1475 | 2021-2022 | Regular Session | Chaptered

California Senate Bill 1475 (Prior Session Legislation)

Bill Title: Blood banks: collection.

Spectrum: Slight Partisan Bill (Democrat 4-2)

Status: (Passed) 2022-09-28 - Chaptered by Secretary of State. Chapter 726, Statutes of 2022. [SB1475 Detail]

Download: California-2021-SB1475-Chaptered.html

Senate Bill No. 1475

CHAPTER 726

An act to amend Section 1607 of the Health and Safety Code, relating to blood banks.

[ Approved by Governor September 28, 2022. Filed with Secretary of State September 28, 2022. ]

LEGISLATIVE COUNSEL'S DIGEST

SB 1475, Glazer. Blood banks: collection.

Existing law requires a blood bank to be licensed by the State Department of Health Care Services. Existing law authorizes specified individuals to collect human blood at a blood bank that meets specified requirements if the collection is under the direct and responsible supervision of a licensed physician or surgeon. Existing regulations authorize blood collection when a physician is not present on the blood bank premises when specified requirements are met, including that a qualified physician or emergency medical facility is no more than 15 minutes away.

Existing law requires a health care provider to obtain verbal or written consent from a patient before the use of telehealth to deliver health care services. An existing executive order has suspended that requirement during the COVID-19 pandemic.

This bill would authorize blood collection at a blood bank when a physician or surgeon is not physically present if the medical director and their medical advisory committee approve and if the employee placed in charge is a registered nurse. The bill would authorize the registered nurse placed in charge to be physically present or available via telehealth, so long as the method of telehealth used is synchronous. The bill would require a blood bank, under these circumstances, to report annually to the department on any adverse donor events requiring emergency medical intervention, including whether a registered nurse was physically present on the premises, and to provide, at the request of the department, written procedures for managing adverse donor reactions. The bill would make these provisions inoperative on January 1, 2028.

Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO

The people of the State of California do enact as follows:

SECTION 1.

Section 1607 of the Health and Safety Code is amended to read:

1607.

(a) Notwithstanding any other 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) (1) Notwithstanding paragraph (2) of subdivision (a), blood may be collected at a blood bank when a physician or surgeon is not physically present on the premises if both of the following conditions are met:

(A) The medical director and their medical advisory committee, if one exists, approves of blood collection without a physician or surgeon present on the premises.

(B) The employee placed in charge, in the absence of a physician or surgeon, is a registered nurse.

(2) The registered nurse placed in charge pursuant to subparagraph (B) of paragraph (1) may be physically present on the premises or may be available via telehealth, as defined in Section 2290.5 of the Business and Professions Code, so long as the method of telehealth used is synchronous.

(3) (A) A blood bank shall annually report to the department any adverse donor events requiring emergency medical intervention that occur pursuant to this subdivision, including the date, location, type of adverse event, onsite response, and whether a registered nurse was physically present on the premises.

(B) At the request of the department, a blood bank shall provide written procedures for managing adverse donor reactions.

(4) This subdivision shall become inoperative on January 1, 2028.

(c) 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.

(d) 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.

(e) 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.

(f) This chapter does not 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.

(g) 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 used in this section, the term “displacement” shall mean a reduction in hours of nonovertime work, the loss of wages, or the loss of employment.

(h) This section does not 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.

(i) For purposes of this section, “American Association of Blood Banks” means the American Association of Blood Banks or its successor organization.