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AB-1494 Blood banks: collection.(2021-2022)

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Date Published: 04/29/2021 09:00 PM
AB1494:v96#DOCUMENT

Amended  IN  Assembly  April 29, 2021
Amended  IN  Assembly  April 22, 2021
Amended  IN  Assembly  April 05, 2021

CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 1494


Introduced by Assembly Member Fong

February 19, 2021


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


LEGISLATIVE COUNSEL'S DIGEST


AB 1494, as amended, Fong. Blood banks: collection.
Existing law requires a blood bank to be licensed by the State Department of Public Health. 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. A violation of these provisions is a misdemeanor. 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.
This bill would authorize blood collection at a blood bank when the employee placed in charge, in the absence of a physician or surgeon, licensed physician and surgeon, is a registered nurse licensed in California. For purposes of a mobile unit, as defined, the bill would authorize require the registered nurse placed in charge to be physically present on the premises or premises, unless certain conditions are met. These conditions would include (1) the registered nurse being immediately available by teleconference, defined as being connected by electronic means, through video. video, (2) the mobile unit collecting blood only in a location with a connection to the internet that can reliably support the use of teleconference, and (3) if blood is collected by a blood donor phlebotomist, the phlebotomist having an active donor phlebotomy technician certificate, as specified.
The bill would require a blood bank to annually report to the department all donor adverse events that occur pursuant to the provision above, including certain information. The bill would require the department, no later than January 1, 2026, to report to the appropriate policy committees of the Legislature the number and types of donor adverse events reported, as specified.
The bill would make the provisions relating to mobile units, including the reporting requirements, inoperative on January 1, 2027.
Because the bill would expand the scope of a crime by adding new requirements for blood banks, the bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Vote: MAJORITY   Appropriation: NO   Fiscal Committee: NOYES   Local Program: NOYES  

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 the employee placed in charge, in the absence of a physician or licensed physician and surgeon, is a registered nurse licensed in California pursuant to Chapter 6 (commencing with Section 2700) of Division 2 of the Business and Professions Code.

(2)

(c) (1) For purposes of a mobile unit, as defined in Section 1600.25, the registered nurse placed in charge pursuant to paragraph (1) may be physically present on the premises or may be available by teleconference. For subdivision (b) shall be physically present on the premises of the mobile unit, unless all of the following conditions are met:
(A) The registered nurse is immediately available by teleconference.
(B) The mobile unit collects blood only in a location with a connection to the internet that can reliably support the use of teleconference for purposes of this paragraph.
(C) If blood is collected by a blood donor phlebotomist, the phlebotomist has an active donor phlebotomy technician certificate issued by the American Society for Clinical Pathology Board of Certification or an equivalent certificate, as determined by the department.
(2) For purposes of this paragraph, subdivision, “teleconference” means that the registered nurse is connected by electronic means, through video.
(3) A blood bank shall annually report to the department all donor adverse events that occur pursuant to this subdivision, including dates, location, and type of adverse event, and whether a registered nurse or a licensed physician and surgeon was physically present on the premises of the mobile unit.
(4) No later than January 1, 2026, the department shall report to the appropriate policy committees of the Legislature the number and types of donor adverse events reported pursuant to paragraph (3) and pursuant to any variance granted under Section 1003 of Title 17 of the California Code of Regulations after March 4, 2020. The report shall include a comparison between the donor adverse event reports for mobile units with a registered nurse physically present on the premises and for mobile units utilizing teleconference.
(5) A report submitted pursuant to paragraph (3) or (4) shall preclude personally identifiable information of donors.
(6) This subdivision shall become inoperative on January 1, 2027.

(c)

(d) 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)

(e) 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)

(f) 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)

(g) 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)

(h) 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)

(i) 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.

SEC. 2.

 No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.