Bill Text: CA AB822 | 2019-2020 | Regular Session | Amended

California Assembly Bill 822 (Prior Session Legislation)

Bill Title: Phlebotomy.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Failed) 2020-02-03 - From committee: Filed with the Chief Clerk pursuant to Joint Rule 56. [AB822 Detail]

Download: California-2019-AB822-Amended.html

Amended IN Assembly April 30, 2019

Amended IN Assembly April 10, 2019

Amended IN Assembly March 07, 2019

CALIFORNIA LEGISLATURE— 2019–2020 REGULAR SESSION

Assembly Bill

No. 822

Introduced by Assembly Member Irwin
(Principal coauthor: Assembly Member Arambula)

February 20, 2019

An act to amend ~~Sections 1242 and~~ Section 1246 of the Business and Professions Code, relating to phlebotomy.

LEGISLATIVE COUNSEL'S DIGEST

AB 822, as amended, Irwin. Phlebotomy.

Existing law provides for the licensure and regulation of clinical laboratories and clinical laboratory personnel and health professionals by the State Department of Public Health and makes a violation of these provisions a crime. Existing law authorizes an unlicensed person employed by a licensed clinical laboratory to perform venipuncture or skin puncture for the purpose of withdrawing blood or for clinical laboratory test purposes upon specific authorization from a licensed physician and surgeon, if that unlicensed person meets certain requirements. Existing law requires an unlicensed person performing these duties to possess a valid and current certification as a certified phlebotomy technician issued by the department.

This bill would specify that the tests an unlicensed person may perform under these provisions include following procedures and using devices approved by the United States Food and Drug Administration for blood collection authorized by the clinical laboratory or other facility employing the person.
This bill would authorize a certified phlebotomy technician to perform a blood draw by means other than venipuncture or skin puncture under specified conditions, including that the blood draw is performed under the general supervision of a physician and surgeon and the blood draw is performed using a device or devices approved by the United States Food and Drug Administration.

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

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

SECTION 1.Section 1242 of the Business and Professions Code is amended to read:
1242.
Any person duly licensed under the provisions of this chapter to perform tests called for in a clinical laboratory may perform skin tests for specific diseases, arterial puncture, venipuncture, or skin puncture for purposes of withdrawing blood or for clinical laboratory test purposes as defined by regulations established by the department and upon specific authorization from any person in accordance with the authority granted under any provisions of law relating to the healing arts. These tests may include following procedures and using devices for blood collection that are authorized by the clinical laboratory or other facility licensed under the Health and Safety Code employing the person.

SEC. 2.SECTION 1.

Section 1246 of the Business and Professions Code is amended to read:

1246.

(a) Except as provided in subdivisions (b) and (c), and in Section 23158 of the Vehicle Code, an unlicensed person employed by a licensed clinical laboratory may perform venipuncture or skin puncture for the purpose of withdrawing blood or for clinical laboratory test purposes, or may follow procedures and use other devices approved by the United States Food and Drug Administration for blood collection that are authorized by the clinical laboratory or other facility licensed under the Health and Safety Code employing the person, purposes upon specific authorization from a licensed physician and surgeon provided that the person meets both of the following requirements:

(1) The person works under the supervision of a person licensed under this chapter or of a licensed physician and surgeon or of a licensed registered nurse. A person licensed under this chapter, a licensed physician or and surgeon, or a registered nurse shall be physically available to be summoned to the scene of the venipuncture within five minutes during the performance of those procedures.

(2) The person has been trained by a licensed physician and surgeon or by a clinical laboratory bioanalyst in the proper procedure to be employed when withdrawing blood in accordance with training requirements established by the department and has a statement signed by the instructing physician and surgeon or by the instructing clinical laboratory bioanalyst that the training has been successfully completed.

(b) (1) On and after the effective date of the regulations specified in paragraph (2), any unlicensed person employed by a clinical laboratory performing the duties described in this section shall possess a valid and current certification as a certified phlebotomy technician issued by the department. However, an unlicensed person employed by a clinical laboratory to perform these duties pursuant to subdivision (a) on that date shall have until January 1, 2007, to comply with this requirement, provided that the person has submitted the application to the department on or before July 1, 2006.

(2) The department shall adopt regulations for certification by January 1, 2001, as a certified phlebotomy technician that shall include all of the following:

(A) The applicant shall hold a valid, current certification as a phlebotomist issued by a national accreditation agency approved by the department, and shall submit proof of that certification when applying for certification pursuant to this section.

(B) The applicant shall complete education, training, and experience requirements as specified by regulations that shall include, but not be limited to, the following:

(i) At least 40 hours of didactic instruction.

(ii) At least 40 hours of practical instruction.

(iii) At least 50 successful venipunctures.

However, an applicant who has been performing these duties pursuant to subdivision (a) may be exempted from the requirements specified in clauses (ii) and (iii), and from 20 hours of the 40 hours of didactic instruction as specified in clause (i), if the applicant has at least 1,040 hours of work experience, as specified in regulations adopted by the department.

It is the intent of the Legislature to permit persons performing these duties pursuant to subdivision (a) to use educational leave provided by their employers for purposes of meeting the requirements of this section.

(C) Each certified phlebotomy technician shall complete at least three hours per year or six hours every two years of continuing education or training. The department shall consider a variety of programs in determining the programs that meet the continuing education or training requirement.

(D) The applicant has been found to be competent in phlebotomy by a licensed physician and surgeon or person licensed pursuant to this chapter.

(E) The applicant works under the supervision of a licensed physician and surgeon, licensed registered nurse, or person licensed under this chapter, or the designee of a licensed physician and surgeon or the designee of a person licensed under this chapter.

(3) The department shall adopt regulations establishing standards for approving training programs designed to prepare applicants for certification pursuant to this section. The standards shall ensure that these programs meet the state’s minimum education and training requirements for comparable programs.

(4) The department shall adopt regulations establishing standards for approving national accreditation agencies to administer certification examinations and tests pursuant to this section.

(5) The department shall charge fees for application for and renewal of the certificate authorized by this section of no more than one hundred dollars ($100) for a two-year period.

(c) (1) (A) A certified phlebotomy technician may perform venipuncture or skin puncture, or may follow other procedures and use devices approved by the United States Food and Drug Administration for blood collection that are authorized by the clinical laboratory or other facility licensed under the Health and Safety Code employing the technician, puncture to obtain a specimen for nondiagnostic tests assessing the health of an individual, for insurance purposes, provided that the technician works under the general supervision of a physician and surgeon licensed under Chapter 5 (commencing with Section 2000). The physician and surgeon may delegate the general supervision duties to a registered nurse or a person licensed under this chapter, but shall remain responsible for ensuring that all those duties and responsibilities are properly performed. The physician and surgeon shall make available to the department, upon request, records maintained documenting when a certified phlebotomy technician has performed venipuncture or skin puncture pursuant to this paragraph.

(B) A certified phlebotomy technician may perform a blood draw by means other than venipuncture or skin puncture if all of the following conditions are met:
(i) The blood draw is performed in a facility licensed under Division 2 (commencing with Section 1200) of the Health and Safety Code.
(ii) The blood draw procedures or protocols are approved by the licensed facility. This paragraph does not authorize the technician to stop or restart a patient’s active intravenous infusion or insert or remove a peripheral intravenous catheter.
(iii) The blood draw is performed under the general supervision of a physician and surgeon licensed under Chapter 5 (commencing with Section 2000). Notwithstanding subparagraph (C), the physician and surgeon may only delegate the supervision duties in this clause to a registered nurse.
(iv) The blood draw is performed using a device or devices approved by the licensed facility and the United States Food and Drug Administration for blood collection.
~~(B)~~

(C) As used in this paragraph, general supervision requires the supervisor of the technician to determine that the technician is competent to perform ~~venipuncture or skin puncture~~ venipuncture, skin puncture, or a blood draw prior to the technician’s first blood withdrawal, and on an annual basis thereafter. The supervisor is also required to determine, on a monthly basis, that the technician complies with appropriate ~~venipuncture or skin puncture~~ venipuncture, skin puncture, and blood draw policies and procedures approved by the medical director and required by state regulations. The supervisor, or another designated licensed physician and surgeon, registered nurse, or person licensed under this chapter, shall be available for consultation with the technician, either in person or through telephonic or electronic means, at the time of blood withdrawal.

(2) (A) Notwithstanding any other law, a person who has been issued a certified phlebotomy technician certificate pursuant to this section may draw blood following policies and procedures approved by a physician and surgeon licensed under Chapter 5 (commencing with Section 2000), appropriate to the location where the blood is being drawn and in accordance with state regulations, including by following procedures and using devices approved by the United States Food and Drug Administration for blood collection that are authorized by the clinical laboratory or other facility licensed under the Health and Safety Code employing that person. regulations. The blood collection shall be done at the request and in the presence of a peace officer for forensic purposes in a jail, law enforcement facility, or medical facility, with general supervision.

(B) As used in this paragraph, “general supervision” means that the supervisor of the technician is licensed under this code as a physician and surgeon, physician assistant, clinical laboratory bioanalyst, registered nurse, or clinical laboratory scientist, and reviews the competency of the technician before the technician may perform blood withdrawals without direct supervision, and on an annual basis thereafter. The supervisor is also required to review the work of the technician at least once a month to ensure compliance with venipuncture policies, procedures, and regulations. The supervisor, or another person licensed under this code as a physician and surgeon, physician assistant, clinical laboratory bioanalyst, registered nurse, or clinical laboratory scientist, shall be accessible to the location where the technician is working to provide onsite, telephone, or electronic consultation, within 30 minutes when needed.

(d) The department may adopt regulations providing for the issuance of a certificate to an unlicensed person employed by a clinical laboratory authorizing only the performance of skin punctures for test purposes.