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AB-1627 Clinical laboratories: certified phlebotomy technicians: blood withdrawal.(2017-2018)

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Date Published: 06/28/2018 09:00 PM
AB1627:v97#DOCUMENT

Amended  IN  Senate  June 28, 2018
Amended  IN  Senate  June 18, 2018

CALIFORNIA LEGISLATURE— 2017–2018 REGULAR SESSION

Assembly Bill No. 1627


Introduced by Assembly Member Chen

February 17, 2017


An act to amend Sections 1242, 1242.5, and amend, repeal, and add Section 1246 of the Business and Professions Code, relating to clinical laboratories.


LEGISLATIVE COUNSEL'S DIGEST


AB 1627, as amended, Chen. Clinical laboratories: unlicensed personnel. certified phlebotomy technicians: blood withdrawal.
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 specified licensed clinical laboratory personnel to perform tasks in a clinical laboratory, such as performing skin tests for specific diseases and arterial puncture for purposes of withdrawing blood or for clinical laboratory test purposes. Existing law prescribes that the department, by regulation, may authorize specified certified laboratory personnel to perform related tasks for the same purposes. Existing law authorizes an unlicensed person employed by a licensed clinical laboratory to perform venipuncture or skin puncture for these purposes as well, 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, as described. 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 additionally authorize specified licensed and unlicensed clinical laboratory personnel to perform blood collection from, and flushing of, a peripheral venous catheter, as described. The bill would prescribe that the department, by regulation, may authorize specified certified laboratory personnel to perform these tasks, as well.

This bill would require the department to revise the regulations for certification as a certified phlebotomy technician to include education and training on blood withdrawal from, and flushing of, as required, a peripheral venous catheter on or before January 1, 2021. The bill would, commencing on January 1, 2021, authorize a certified phlebotomy technician to withdraw blood from, and flush, as required, a peripheral venous catheter upon specific authorization from a licensed physician and surgeon, if he or she meets certain requirements, as described.
Because a willful violation of requirements related to the licensure and regulation of clinical laboratories and clinical laboratory personnel and health professionals would be a crime, 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: YES   Local Program: YES  

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.

A person duly licensed under 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, or to perform blood collection from, and flushing of, as required, a peripheral venous catheter, 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.

SEC. 2.Section 1242.5 of the Business and Professions Code is amended to read:
1242.5.

Notwithstanding paragraphs (2) and (3) of subdivision (b) of Section 1241, the department may by regulation authorize laboratory personnel certified pursuant to Section 1246 to perform venipuncture, arterial puncture, or skin puncture for the purposes of withdrawing blood or for clinical laboratory test purposes, or to perform blood collection from, and flushing of, as required, a peripheral venous catheter, as defined by regulations established by the department.

SEC. 3.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 to perform blood collection from, and flushing of, as required, a peripheral venous catheter, purposes upon specific authorization from a licensed physician and surgeon provided that he or she meets both of the following requirements:
(1) He or she 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 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) He or she 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 he or she 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.
(iv) At least 50 successful blood withdrawals from a peripheral venous catheter.
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 he or she 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) A 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) He or she has been found to be competent in phlebotomy by a licensed physician and surgeon or person licensed pursuant to this chapter.
(E) He or she 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 revise the regulations for certification as a certified phlebotomy technician to include education and training on blood withdrawal from, and flushing of, as required, a peripheral venous catheter on or before January 1, 2021.

(3)

(4) 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)

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

(5)

(6) 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 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) 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 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 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. 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.
(e) This section shall remain in effect only until January 1, 2021, and as of that date is repealed.

SEC. 2.

 Section 1246 is added to the Business and Professions Code, 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 withdraw blood from, and flush, as required, a peripheral venous catheter upon specific authorization from a licensed physician and surgeon provided that he or she meets both of the following requirements:
(1) He or she 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 surgeon, or a registered nurse shall be physically available to be summoned to the scene of the venipuncture or blood withdrawal from, and flushing of, as required, a peripheral venous catheter within five minutes during the performance of those procedures. The licensed person managing the patient from whom blood is to be drawn shall determine whether a blood draw from a peripheral venous catheter is clinically appropriate.
(2) He or she 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) 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.
(2) The department shall adopt regulations for certification 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.
(iv) At least 50 successful blood withdrawals from a peripheral venous catheter.
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 he or she 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) A 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) He or she has been found to be competent in phlebotomy by a licensed physician and surgeon or person licensed pursuant to this chapter.
(E) He or she 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 withdraw blood from, and flush, as required, a peripheral venous catheter or perform venipuncture or skin 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 withdrawn blood from a peripheral venous catheter or performed venipuncture or skin puncture pursuant to this paragraph.
(B) As used in this paragraph, general supervision requires the supervisor of the technician to determine that the technician is competent to withdraw blood from a peripheral venous catheter or perform venipuncture or skin puncture 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 peripheral venous catheter, venipuncture, or skin puncture 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. 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 and peripheral venous catheter 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.
(e) This section shall become operative on January 1, 2021.

SEC. 4.SEC. 3.

 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.