AB 1627: Clinical laboratories: certified phlebotomy technicians: blood withdrawal.
- Session Year: 2017-2018
- House: Assembly
- Latest Version Date: 2018-06-28
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.
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, upon specific authorization from a licensed physician and surgeon, if that unlicensed person meets certain requirements, as described.
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.
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.
Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), enacted by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, and use of marijuana for nonmedical purposes by people 21 years of age and older. Under existing law, the Bureau of Marijuana Control is responsible for licensing and regulating retail sales, distribution, and transportation, and the State Department of Public Health is responsible for licensing and regulating testing laboratories. Existing law, the Medical Cannabis Regulation and Safety Act (MCRSA), regulates the cultivation, distribution, and use of cannabis for medical purposes. Under that act, the Bureau of Marijuana Control is responsible for licensing and regulating retail sales, distribution, transportation, and testing laboratories. This bill would transfer the regulation of testing laboratories under AUMA from the State Department of Public Health to the bureau.AUMA authorizes the Legislature to amend, by a majority vote, certain provisions of the act to implement specified substantive provisions, provided that the amendments are consistent with and further the purposes and intent of the act.This bill would declare that its provisions implement specified substantive provisions of AUMA. The bill would also declare that its provisions further specified purposes and the intent of that act.Existing law, the Control, Regulate and Tax Adult Use of Marijuana Act (AUMA), enacted by the voters at the November 8, 2016, statewide general election, regulates the cultivation, distribution, and use of marijuana for nonmedical purposes by people 21 years of age and older. Under existing law, the Bureau of Marijuana Control is responsible for licensing and regulating retail sales, distribution, and transportation, and the State Department of Public Health is responsible for licensing and regulating testing laboratories.
Existing law, the Medical Cannabis Regulation and Safety Act (MCRSA), regulates the cultivation, distribution, and use of cannabis for medical purposes. Under that act, the Bureau of Marijuana Control is responsible for licensing and regulating retail sales, distribution, transportation, and testing laboratories.
This bill would transfer the regulation of testing laboratories under AUMA from the State Department of Public Health to the bureau.
AUMA authorizes the Legislature to amend, by a majority vote, certain provisions of the act to implement specified substantive provisions, provided that the amendments are consistent with and further the purposes and intent of the act.
This bill would declare that its provisions implement specified substantive provisions of AUMA. The bill would also declare that its provisions further specified purposes and the intent of that act.
(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 states 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 technicians 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 states 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 technicians 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 XIIIB 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 XIIIB of the California Constitution.
Any A 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 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, 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 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 purposes, or to perform blood collection from, and flushing of, 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 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.
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)Each 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 states 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 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 technicians 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 provision of 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.
SEC. 4.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
All matter omitted in this version of the bill appears in the bill as introduced in the Assembly, February 17, 2017. (JR11)For purposes of this division, the following definitions shall apply:
(a)Applicant means the following:
(1)The owner or owners of a proposed licensee. Owner means all persons having (A) an aggregate ownership interest (other interest, other than a security interest, lien, or encumbrance) encumbrance, of 20 percent or more in the licensee and (B) the power to direct direct, or cause to be directed, the management or control of the licensee.
(2)If the applicant is a publicly traded company, owner includes the chief executive officer and any member of the board of directors and any person or entity with an aggregate ownership interest in the company of 20 percent or more. If the applicant is a nonprofit entity, owner means both the chief executive officer and any member of the board of directors.
(b)Bureau means the Bureau of Marijuana Control within the Department of Consumer Affairs.
(c)Child resistant means designed or constructed to be significantly difficult for children under five years of age to open, and not difficult for normal adults to use properly.
(d)Commercial marijuana activity includes the cultivation, possession, manufacture, distribution, processing, storing, laboratory testing, labeling, transportation, distribution, delivery delivery, or sale of marijuana and marijuana products as provided for in this division.
(e)Cultivation means any activity involving the planting, growing, harvesting, drying, curing, grading, or trimming of marijuana.
(f)Customer means a natural person 21 years of age or over.
(g)Day care center shall have the same meaning as in Section 1596.76 of the Health and Safety Code.
(h)Delivery means the commercial transfer of marijuana or marijuana products to a customer. Delivery also includes the use by a retailer of any a technology platform platform, owned and controlled by the retailer, retailer or independently licensed under this division, that enables customers to arrange for or facilitate the commercial transfer by a licensed retailer of marijuana or marijuana products.
(i)Director means the Director of the Department of Consumer Affairs.
(j)Distribution means the procurement, sale, and transport of marijuana and marijuana products between entities licensed pursuant to this division.
(k)Fund means the Marijuana Control Fund established pursuant to Section 26210.
(l)Kind means applicable type or designation regarding a particular marijuana variant or marijuana product type, including, but not limited to, strain name or other grower trademark, or growing area designation.
(m)License means a state license issued under this division.
(n)Licensee means any a person or entity holding a license under this division.
(o)Licensing authority means the state agency responsible for the issuance, renewal, or reinstatement of the license, or the state agency authorized to take disciplinary action against the licensee.
(p)Local jurisdiction means a city, county, or city and county.
(q)Manufacture means to compound, blend, extract, infuse, or otherwise make or prepare a marijuana product.
(r)Manufacturer means a person that conducts the production, preparation, propagation, or compounding of marijuana or marijuana products either directly or indirectly or by extraction methods, or independently by means of chemical synthesis, or by a combination of extraction and chemical synthesis at a fixed location that packages or repackages marijuana or marijuana products or labels or re-labels its container, that holds a state license pursuant to this division.
(s)Marijuana has the same meaning as in Section 11018 of the Health and Safety Code, except that it does not include marijuana that is cultivated, processed, transported, distributed, or sold for medical purposes under Chapter 3.5 (commencing with Section 19300) of Division 8.
(t)Marijuana accessories has the same meaning as in Section 11018.2 of the Health and Safety Code.
(u)Marijuana products has the same meaning as in Section 11018.1 of the Health and Safety Code, except that it does not include marijuana products manufactured, processed, transported, distributed, or sold for medical purposes under Chapter 3.5 (commencing with Section 19300) of Division 8.
(v)Nursery means a licensee that produces only clones, immature plants, seeds, and other agricultural products used specifically for the planting, propagation, and cultivation of marijuana.
(w)Operation means any an act for which licensure is required under the provisions of this division, or any commercial transfer of marijuana or marijuana products.
(x)Package means any a container or receptacle used for holding marijuana or marijuana products.
(y)Person includes any an individual, firm, copartnership, joint venture, association, corporation, limited liability company, estate, trust, business trust, receiver, syndicate, or any other group or combination acting as a unit, and the plural as well as the singular.
(z)Purchaser means the customer who is engaged in a transaction with a licensee for purposes of obtaining marijuana or marijuana products.
(aa)Sell, sale, and to sell include any transaction whereby, for any consideration, title to marijuana is transferred from one person to another, and includes the delivery of marijuana or marijuana products pursuant to an order placed for the purchase of the same and soliciting or receiving an order for the same, but does not include the return of marijuana or marijuana products by a licensee to the licensee from whom such that marijuana or marijuana product was purchased.
(bb)
(ab)Testing service means a laboratory, facility, or entity in the state, that offers or performs tests of marijuana or marijuana products, including the equipment provided by such that laboratory, facility, or entity, and that is both of the following:
(1)Accredited by an accrediting body that is independent from all other persons involved in commercial marijuana activity in the state.
(2)Registered with the State Department of Public Health. Bureau of Marijuana Control.
(cc)
(ac)Unique identifier means an alphanumeric code or designation used for reference to a specific plant on a licensed premises.
(dd)
(ad)Unreasonably impracticable means that the measures necessary to comply with the regulations require such a high investment of risk, money, time, or any other resource or asset, that the operation of a marijuana establishment is not worthy of being carried out in practice by a reasonably prudent business person.
(ee)
(ae)Youth center shall have the same meaning as in Section 11353.1 of the Health and Safety Code.
SEC. 2.Section 26012 of the Business and Professions Code is amended to read:26012.(a)It being a matter of statewide concern, except as otherwise authorized in this division:
(1)The Department of Consumer Affairs shall have the exclusive authority to create, issue, renew, discipline, suspend, or revoke licenses for the transportation, storage unrelated to manufacturing activities, distribution, testing, and sale of marijuana within the state.
(2)The Department of Food and Agriculture shall administer the provisions of this division related to and associated with the cultivation of marijuana. The Department of Food and Agriculture shall have the authority to create, issue, and suspend or revoke cultivation licenses for violations of this division.
(3)The State Department of Public Health shall administer the provisions of this division related to and associated with the manufacturing and testing of marijuana. The State Department of Public Health shall have the authority to create, issue, and suspend or revoke manufacturing and testing licenses for violations of this division.
(b)The licensing authorities and the bureau shall have the authority to collect fees in connection with activities they regulate concerning marijuana. The bureau may create licenses in addition to those identified in this division that the bureau deems necessary to effectuate its duties under this division.
(c)Licensing authorities shall begin issuing licenses under this division by January 1, 2018.
SEC. 3.Section 26100 of the Business and Professions Code is amended to read:26100.(a)The State Department of Public Health shall promulgate regulations governing the licensing of marijuana manufacturers and testing laboratories. manufacturers. Licenses to be issued are as follows:
(a)(1)Manufacturing Level 1, for sites that manufacture marijuana products using nonvolatile solvents, or no solvents.
(b)(2)Manufacturing Level 2, for sites that manufacture marijuana products using volatile solvents.
(b)(1)The Bureau of Marijuana Control shall promulgate regulations governing the licensing of marijuana testing laboratories as follows:
(c)(2)Testing, for testing of marijuana and marijuana products. Testing licensees shall have their facilities or devices licensed according to regulations set forth by the department. bureau. A testing licensee shall not hold a license in another license category of this division and shall not own or have ownership interest in a non-testing facility licensed pursuant to this division.
(d)(c)For purposes of this section, volatile solvents shall have the same meaning as in subdivision (d) of Section 11362.3 of the Health and Safety Code unless otherwise provided by law or regulation.
SEC. 4.Section 26101 of the Business and Professions Code is amended to read:26101.(a)Except as otherwise provided by law, no marijuana or marijuana products may be sold pursuant to a license provided for under this division unless a representative sample of such that marijuana or marijuana product has been tested by a certified testing service to determine:
(1)Whether the chemical profile of the sample conforms to the labeled content of compounds, including, but not limited to, all of the following:
(A)Tetrahydrocannabinol (THC).
(B)Tetrahydrocannabinolic Acid (THCA).
(C)Cannabidiol (CBD).
(D)Cannabidiolic Acid (CBDA).
(E)The terpenes described in the most current version of the cannabis inflorescence monograph published by the American Herbal Pharmacopoeia.
(F)Cannabigerol (CBG).
(G)Cannabinol (CBN).
(2)That the presence of contaminants does not exceed the levels in the most current version of the American Herbal Pharmacopoeia monograph. For purposes of this paragraph, contaminants includes, but is not limited to, all of the following:
(A)Residual solvent or processing chemicals, including explosive gases, such as Butane, propane, O2 or H2, and poisons, toxins, or carcinogens, such as Methanol, Isopropyl Alcohol, Methylene Chloride, Acetone, Benzene, Toluene, and Tri-chloro-ethylene.
(B)Foreign material, including, but not limited to, hair, insects, or similar or related adulterant.
(C)Microbiological impurity, including total aerobic microbial count, total yeast mold count, P. aeruginosa, aspergillus spp., s. aureus, aflatoxin B1, B2, G1, or G2, or ochratoxin A.
(b)Residual levels of volatile organic compounds shall satisfy standards of the cannabis inflorescence monograph set by the United States Pharmacopeia (U.S.P. Chapter 467).
(c)The testing required by paragraph (a) shall be performed in a manner consistent with general requirements for the competence of testing and calibrations activities, including sampling, using standard methods established by the International Organization for Standardization, specifically ISO/IEC 17020 and ISO/IEC 17025 to test marijuana and marijuana products that are approved by an accrediting body that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Agreement.
(d)Any pre-sale inspection, testing transfer, or transportation of marijuana products pursuant to this section shall conform to a specified chain of custody protocol and any other requirements imposed under this division.
(e)The State Department of Public Health and the Department of Pesticide Regulation shall provide assistance to the bureau in developing regulations, as requested by the bureau.
SEC. 5.Section 26104 of the Business and Professions Code is amended to read:26104.(a)A licensed testing service shall, in performing activities concerning marijuana and marijuana products, comply with the requirements and restrictions set forth in applicable law and regulations.
(b)The State Department of Public Health Bureau of Marijuana Control shall develop procedures to: to do all of the following:
(1)Ensure that testing of marijuana and marijuana products occurs prior to distribution to retailers, microbusinesses, or nonprofits licensed under Section 26070.5; 26070.5.
(2)Specify how often licensees shall test marijuana and marijuana products, and that the cost of testing marijuana shall be borne by the licensed cultivators and the cost of testing marijuana products shall be borne by the licensed manufacturer, and that the costs of testing marijuana and marijuana products shall be borne by a nonprofit licensed under Section 26070.5; and 26070.5.
(3)Require destruction of harvested batches whose testing samples indicate noncompliance with health and safety standards promulgated by the State Department of Public Health, bureau, unless remedial measures can bring the marijuana or marijuana products into compliance with quality assurance standards as promulgated by the State Department of Public Health. bureau.
SEC. 6.The Legislature finds and declares that this bill implements Section 6.1 of the Control, Regulate and Tax Adult Use of Marijuana Act, and that it is consistent with and furthers the purposes of the act as stated in Section 3.
|
Date
|
Status
|
|---|---|
| Aug 16, 2018 | In committee: Held under submission. |
| Aug 6, 2018 | In committee: Referred to APPR. suspense file. |
| Jun 28, 2018 | Read second time and amended. Re-referred to Com. on APPR. |
| Jun 27, 2018 | From committee: Amend, and do pass as amended and re-refer to Com. on APPR. (Ayes 7. Noes 0.) (June 25). |
| Jun 18, 2018 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D. |
| Jun 12, 2017 | In committee: Set, first hearing. Hearing canceled at the request of author. |
| May 24, 2017 | Referred to Com. on B., P. & E.D. |
| May 11, 2017 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 11, 2017 | Read third time. Passed. Ordered to the Senate. (Ayes 77. Noes 0. Page 1485.) |
| May 4, 2017 | Read second time. Ordered to Consent Calendar. |
| May 3, 2017 | From committee: Do pass. To Consent Calendar. (Ayes 16. Noes 0.) (May 3). |
| Apr 26, 2017 | From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 15. Noes 0.) (April 25). Re-referred to Com. on APPR. |
| Mar 27, 2017 | Referred to Com. on B. & P. |
| Feb 19, 2017 | From printer. May be heard in committee March 21. |
| Feb 17, 2017 | Read first time. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 6, 2018 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Jun 25, 2018 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| May 11, 2017 | AB 1627 COOLEY Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| May 3, 2017 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 25, 2017 | Do pass and be re-referred to the Committee on [Appropriations] with recommendation: To Consent Calendar | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| Aids Healthcare Foundation | ** Against | Jun 22, 2018 |
| California Association For Medical Laboratory Technology | ** Against | Jun 22, 2018 |
| California Nurses Association | ** Against | Jun 22, 2018 |
| National Nurses United | ** Against | Jun 22, 2018 |
| Velano Vascular | ** Support | Jun 22, 2018 |
SENATE COMMITTEE ON
Senator Anthony Portantino, Chair
2017 - 2018 Regular Session
AB 1627 (Chen) - Clinical laboratories: certified phlebotomy technicians: blood withdrawal
Version: | Policy Vote: |
Urgency: | Mandate: |
Hearing Date: | Consultant: |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
Requires, by January 1, 2021, CDPH to revise regulations for certification of a phlebotomy technician to include education and training blood withdrawal from, and flushing of, a peripheral venous catheter. Revises and recasts existing law, governing certification of phlebotomy technicians.
Fiscal Impact:
Staff estimates bill implementation costs could include:
- Limited-term costs of $253,564 (California Laboratory Improvement Fund) for CDPH’s administrative workload to promulgate regulations related to authorization for a CPT to draw blood in this manner, issue related bulletins, and respond to public inquiries regarding the bill’s provisions.
- Staff notes potential ongoing administrative and enforcement costs, related to complaint investigations, which can be absorbed.
Background:
The Department of Public Health certifies phlebotomists. An applicant must have at least a general education diploma, training from an accredited phlebotomy program, and passed a national certification. There are three levels of phlebotomy certification, each with a different scope of practice:
- Limited Phlebotomy Technician (LPT) - Authorized to do skin puncture blood collection only.
- Certified Phlebotomy Technician I (CPT I) - Authorized to do skin puncture and venipuncture blood collection. There are different requirements for applicants with no phlebotomy experience, applicants with less than 1040 hours of on-the-job phlebotomy experience, and applicants with 1040 or more hours of on-the-job phlebotomy experience in the last 5 years.
- Certified Phlebotomy Technician II (CPT II) - Authorized to do skin puncture, venipuncture, and arterial puncture blood collection.
A PVC is a “device used to draw blood and give treatments, including intravenous fluids, drugs, or blood transfusions. A thin, flexible tube is inserted into a vein, usually in the back of the hand, the lower part of the arm, or the foot. A needle is inserted into a port to draw blood or give fluids.” It is often referred to as an IV. This bill would expand the scope of practice of a CPT in order to utilize a new technology for drawing blood that connects to an IV. This bill amends a CPT’s scope of practice by allowing a CPT to draw blood from, and flush, a PVC. Current law authorizes only registered nurses to draw blood using an IV.
Proposed Law:
Assembly Bill 1627 includes the following provisions, among others:
- Requires, by January 1, 2021, CDPH to revise regulations for certification of a phlebotomy technician to include education and training blood withdrawal from, and flushing of, a peripheral venous catheter.
- Adds to the existing education, training, and experience requirements for a certified phlebotomy technician to include at least 50 successful blood withdrawals from a peripheral venous catheter.
- Sunsets existing provisions, governing the certification of phlebotomy technicians, and recasts many of those same existing provisions, effective January 1, 2021, as follows:
- 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 they meet specified requirements.
- Requires CDPH to adopt regulations for certification as a certified phlebotomy technician that must include specified information, such as an applicant’s education and training experience, mandatory continuing education or training.
- Authorizes CDPH to charge no more than one hundred dollars ($100) for a two-year period for application and renewal of the certification.
- Authorizes a certified phlebotomy technician to withdraw blood from, and flush, a PVC or perform venipuncture or skin puncture to obtain a specimen for nondiagnostic tests assessing the health of an individual, for insurance purposes, under specified circumstances.
- Authorizes CDPH to issue 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.
Staff Comments:
This bill is in response to recent healthcare technology improvements related to IV, specifically, PIVO, “an FDA-cleared, single-use, disposable blood collection device that enables a lab quality blood draw from the vein utilizing an indwelling peripheral IV catheter as a conduit into the vessel.”
A relatively simple regulation packet could move through the process in as few as 15-18 months, while regulations pertaining to more complicated subject matter can sometimes take several years, depending on the volume of public comments.
-- END --
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2017 - 2018 Regular
Bill No: Hearing Date: June 25, 2018
Author: | Chen | ||
Version: | June 18, 2018 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | Sarah Huchel | ||
Subject: Clinical laboratories: unlicensed personnel.
SUMMARY:
Authorizes specified licensed clinical laboratory personnel and a certified phlebotomy technician (CBT) to draw blood from, and flush, a peripheral venous catheter (PVC).
Existing law:
- Authorizes a CPT to draw blood via venipuncture or skin puncture. (Business and Professions Code (BPC) § 1246)
- Requires an application for certification as a phlebotomy technician by the Department of Public Health (DPH) to include proof of the following:
- The applicant holds a valid, current certification as a phlebotomist issued by a national accreditation agency approved by DPH.
- The applicant completed education, training, and experience requirements as specified by regulations that shall include, but not be limited to, the following:
- At least 40 hours of didactic instruction.
- At least 40 hours of practical instruction.
- At least 50 successful venipunctures. (BPC § 1246)
- Establishes requirements for certification of the various levels of phlebotomy technician. (Title 17, California Code of Regulations § 1034)
- Prohibits unlicensed personnel from performing various functions performed by nurses, including intravenous therapy, parenteral or tube feedings, and invasive procedures including inserting catheters, except as specified. (BPC § 2725.3)
This bill:
- Authorizes clinical laboratory personnel who are licensed to perform tests called for in a clinical laboratory to perform blood collection from, and flushing of, as required, a PVC, as defined by regulations established by DPH and upon specific authorization from any person in accordance with the authority granted under any provisions of law relating to the healing arts.
- Authorizes a CPT to perform blood collection from, and flushing of, as required, a PVC upon specific authorization from a licensed physician and surgeon, as specified.
- Makes technical changes.
FISCAL EFFECT:
This bill is keyed fiscal by Legislative Counsel. This bill was not analyzed by the Assembly Appropriations Committee in its current form.
COMMENTS:
- Purpose. This bill is sponsored by Velano Vascular. According to the Author’s office, “AB 1627 would authorize phlebotomists to utilize an FDA cleared device that allows blood to be drawn through an IV catheter and avoids the patient experiencing a painful venipuncture (needle stick) method to get their blood specimen.”
- Peripheral Venous Catheter. According to the National Cancer Institute, a PVC is a “device used to draw blood and give treatments, including intravenous fluids, drugs, or blood transfusions. A thin, flexible tube is inserted into a vein, usually in the back of the hand, the lower part of the arm, or the foot. A needle is inserted into a port to draw blood or give fluids.” It is often referred to as an IV.
According to a November 15, 2017 article in Clinical Infectious Diseases, Short-term Peripheral Venous Catheter–Related Bloodstream Infections: A Systematic Review, PVCs are commonly used in healthcare settings, and can often be the site of infection, depending on various clinical factors.
This bill would expand the scope of practice of a CPT in order to utilize a new technology for drawing blood that connects to an IV. The sponsors of this bill, Velano Vascular, describe their product as a “needle-free device [that] utilizes the existing opening of your IV, rather than sticking you with a needle. It attaches to your IV, then sends a small, flexible inner tube into the vein to collect the blood sample. Once complete, the tube is retracted and the device is removed from your IV and discarded.”
Their devices were approved for marketing by the FDA in February 2015 and 2017, and are currently in use throughout the United States, but particularly by phlebotomists in Ohio, Connecticut, and Utah. It is unclear whether these phlebotomists have training and education requirements similar to California CBTs.
- Certified Phlebotomist. California does not license phlebotomists, but rather requires certification by DPH. To become certified, an applicant must have at least a general education diploma, training from an accredited phlebotomy program, and passed a national certification.
There are three levels of phlebotomy certification, each with a different scope of practice:
- Limited Phlebotomy Technician (LPT) - Authorized to do skin puncture blood collection only.
- Certified Phlebotomy Technician I (CPT I) - Authorized to do skin puncture and venipuncture blood collection. There are different requirements for applicants with no phlebotomy experience, applicants with less than 1040 hours of on-the-job phlebotomy experience, and applicants with 1040 or more hours of on-the-job phlebotomy experience in the last 5 years.
- Certified Phlebotomy Technician II (CPT II) - Authorized to do skin puncture, venipuncture, and arterial puncture blood collection.
This bill amends a CBT’s scope of practice by allowing a CBT to draw blood from, and flus, a PVC.
Current law authorizes only registered nurses to draw blood using an IV, but the sponsors of this bill believe it is safe enough to allow CPTs to do so, as well.
- Arguments in Support. “Velano Vascular is the developer of PIVO – an FDA-cleared, single-use, disposable blood collection device that enables a lab quality blood draw from the vein utilizing an indwelling peripheral IV catheter as a conduit into the vessel. For hospitalized patients with a peripheral IV, this device avoids the painful and ubiquitous needle sticks required today for blood collection. By removing the needle from this procedure, this device also aims to improve practitioner safety while reducing practitioner anxiety when drawing blood from difficult venous access patients such as the chronically ill and children. …
“Current law specifically defines the duty of a phlebotomist to ‘perform skin tests for specific diseases, arterial puncture, venipuncture, or skin puncture for purposes of withdrawing blood. ’ Unfortunately, current law did not foresee newer technologies, and this definition limits phlebotomists only to needle sticks. It does not make sense that, while this technology is currently used in California by nurses, it cannot be used by the one profession whose sole purpose is to withdraw blood – phlebotomists. AB 1627 will fix this discrepancy by updating current law and allow phlebotomists to utilize this advancement in health technology.”
- Arguments in Opposition. The California Nurses Association/National Nurses United (CNA) writes, “CNA is aware of the studies that have demonstrated the effectiveness of the new needleless PIVO device [the technology enabling the scope expansion of this bill] for blood withdrawal from an indwelling peripherally inserted short catheter. We strenuously disagree with the notion that the use of this new device for blood withdrawal from an indwelling catheter should be performed by clinical laboratory phlebotomists who are not trained in the insertion or management of intravenous catheters or the management of patients receiving intravenous therapy.
“A careful reading of the current statutory language regarding training requirements for CPTs demonstrates that nothing in the statutory or regulatory language prepares phlebotomists for the care and management of peripherally inserted intravenous catheters. They are trained to use needles to puncture the skin and to withdraw blood for laboratory analysis. Their training does not include stopping intravenous site or re-starting the intravenous infusion after blood has been withdrawn.”
- Policy Concerns. This bill does not contain any additional educational requirements or direction to DPH to promulgate updated regulations requiring additional education or training before a CPT may be authorized to draw blood in this manner. It is unclear whether a CPT currently has the appropriate training and/or education to perform this skill.
SUPPORT AND OPPOSITION:
Support:
Velano Vascular (Sponsor)
Opposition:
AIDS Healthcare Foundation
California Association for Medical Laboratory Technology
California Nurses Association/National Nurses United
-- END --
Date of Hearing: May 3, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
ABPCA Bill Id:AB 1627
Author:(Cooley) – As Introduced Ver:February 17, 2017
Policy Committee: | Business and Professions | Vote: | 15 - 0 |
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill transfers the regulation of testing laboratories under the Adult Use of Marijuana Act (AUMA) from the California Department of Public Health (CDPH) to the Bureau of Marijuana Control (Bureau).
FISCAL EFFECT:
Negligible state fiscal effect. The Bureau is already charged with regulating testing laboratories under the Medical Cannabis Regulation and Safety Act (MCRSA), which creates a regulatory structure for medical cannabis. This bill simply modifies which department issues laboratory testing licenses for recreational cannabis, in order to align the regulatory structure with that the state adopted under MCRSA.
COMMENTS:
- Purpose. The author explains the purpose of this bill is to align laboratory testing regulation in AUMA with MCRSA.
- Background. In 1996, voters approved Proposition 215, which legalized the use of medical cannabis in California. There was little state oversight of medical cannabis until 2015, when California enacted three bills that established MCRSA, a comprehensive state regulatory framework for the licensing and enforcement of cultivation, manufacturing, retail sale, transportation, storage, delivery and testing of medical cannabis. Senate Bill 837 (Committee on Budget, Chapter 32, Statutes of 2016) further built upon the MCRSA framework. In November of 2016, voters approved Proposition 64, or AUMA. Under this proposition, adults 21 years of age or older can legally grow, possess, and use cannabis for non-medical purposes, with certain restrictions. In addition, beginning on January 1, 2018, AUMA makes it legal to sell and distribute cannabis through a regulated business.
- Related Trailer Bill Proposal. The administration has proposed trailer bill language that seeks to clarify and enhance both propositions, as passed by the voters, by allowing for a clear regulatory structure and eliminating ambiguity. The administration notes the necessity of one regulatory structure for all cannabis activities across California to maximize public and consumer safety. The trailer bill also proposes transferring regulatory authority from CDPH to the Bureau, as proposed in this bill.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: April 25, 2017
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Evan Low, Chair
ABPCA Bill Id:AB 1627
Author:(Cooley) – As Introduced Ver:February 17, 2017
SUBJECT: Adult Use Marijuana Act: testing laboratories.
SUMMARY: Transfers the regulation of testing laboratories from the State Department of Public Health (CDPH) to the Bureau of Marijuana Control (Bureau).
EXISTING LAW:
- Establishes the Bureau, also referred to as the Bureau of Medical Cannabis Regulation under the Department of Consumer Affairs (DCA), to establish a comprehensive system to control and regulate the cultivation, distribution, transport, storage, manufacturing, processing, and sale of cannabis products. (Business and Professions Code (BPC) § 26000 et seq.; BPC § 19302)
- Directs the State Department of Public Health (CDPH) to promulgate regulations governing the licensing of marijuana manufacturers and testing laboratories. Licenses to be issued are as follows: (BPC § 26100)
- “Manufacturing Level 1,” for sites that manufacture marijuana products using nonvolatile solvents, or no solvents.
- “Manufacturing Level 2,” for sites that manufacture marijuana products using volatile solvents.
- Directs the CDPH to develop procedures to: (BPC § 26104)
- Ensure that testing of marijuana and marijuana products occurs prior to distribution to retailers, microbusinesses, or licensed nonprofits
- Specify how often licensees shall test marijuana and marijuana products, and that the cost of testing marijuana shall be borne by the licensed cultivators and the cost of testing marijuana products shall be borne by the licensed manufacturer, and that the costs of testing marijuana and marijuana products shall be borne by a licensed nonprofit.
- Require destruction of harvested batches whose testing samples indicate noncompliance with health and safety standards promulgated by the CDPH, unless remedial measures can bring the marijuana or marijuana products into compliance with quality assurance standards as promulgated by the CDPH.
THIS BILL:
- Declares that the DCA has the exclusive authority to create, issue, renew, discipline, suspend, or revoke licenses for the transportation, storage unrelated to manufacturing activities, distribution, testing, and sale of marijuana within the state.
- Specifies that a “testing service,” is defined as a laboratory, facility, or entity in the state, that offers or performs tests of marijuana or marijuana products, including the equipment provided by that laboratory, facility, or entity, and that is both of the following:
- Accredited by an accrediting body that is independent from all other persons involved in commercial marijuana activity in the state; and,
- Registered with the Bureau.
- Directs CDPH to promulgate regulations governing the licensing of marijuana manufacturers.
- Directs the Bureau to promulgate regulations governing the licensing of marijuana testing laboratories as follows:
- “Testing,” for testing of marijuana and marijuana products. Testing licensees shall have their facilities or devices licensed according to regulations set forth by the Bureau. A testing licensee shall not hold a license in another license category of this division and shall not own or have ownership interest in a non-testing facility licensed pursuant to this division.
- Requires the CDPH and the Department of Pesticide Regulation to provide assistance to the bureau in developing regulations, as requested by the Bureau.
- Requires the Bureau to do all of the following:
- Ensure that testing of marijuana and marijuana products occurs prior to distribution to licensed retailers, microbusinesses, or nonprofits;
- Specify how often licensees shall test marijuana and marijuana products, and that the cost of testing marijuana shall be borne by the licensed cultivators and the cost of testing marijuana products shall be borne by the licensed manufacturer, and that the costs of testing marijuana and marijuana products shall be borne by a licensed nonprofit; and,
- Require destruction of harvested batches whose testing samples indicate noncompliance with health and safety standards promulgated by the Bureau, unless remedial measures can bring the marijuana or marijuana products into compliance with quality assurance standards as promulgated by the Bureau.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the author. According to the author, “The Medical Cannabis Regulation and Safety Act (MCRSA) was a landmark accomplishment of the 2015 legislative session. For the first time it established a comprehensive regulatory framework for medical cannabis in California.
Under MCRSA, the Bureau of Medical Cannabis Regulation has the responsibility for regulating and licensing retail sales, distribution, transportation, and testing labs. Subsequently, under Proposition 64, the responsibility for regulating and licensing testing labs for recreational cannabis was placed under the CDPH. While CDPH is the correct department to create the standards testing labs must follow for cannabis, the licensing and regulatory function more appropriately resides under the Bureau. [This bill] moves regulation and licensing of recreational testing labs from CDPH back to the Bureau.”
Background. Current law establishes that the Bureau has the responsibility for regulating and licensing retail sales, distribution, transportation, and testing labs. Under Proposition 64, the responsibility for regulating and licensing testing labs for recreational cannabis is placed under the CDPH.
The author believes that CDPH is the correct department to create the standards testing labs must follow for cannabis, but that the licensing and regulatory function more appropriately resides under the Bureau.
REGISTERED SUPPORT:
None on file.
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / 916-319-3301
Discussed in Hearing
Senate Standing Committee on Appropriations
Bill Author
Bill Co-Author(s):