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AB-1328 Clinical laboratory technology and pharmacists.(2021-2022)



Current Version: 03/23/21 - Amended Assembly Compare Versions information image


AB1328:v98#DOCUMENT

Amended  IN  Assembly  March 23, 2021

CALIFORNIA LEGISLATURE— 2021–2022 REGULAR SESSION

Assembly Bill
No. 1328


Introduced by Assembly Member Irwin

February 19, 2021


An act to amend Sections 1206, 1206.5, 1206.6, 4050, 4052, 4052.2, and 4052.4 of the Business and Professions Code, relating to healing arts.


LEGISLATIVE COUNSEL'S DIGEST


AB 1328, as amended, Irwin. Clincal Clinical laboratory technology and pharmacists.
(1) Existing law provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the State Department of Public Health. Existing law provides that nothing in those provisions restrict, limit, or prevent any person licensed to provide health care services under the state’s laws, including, but not limited to, licensed physicians and surgeons and registered nurses, from practicing the professions or occupation for which they are licensed. Existing law provides that nothing in those provisions authorize any person to perform or order health care services or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide that care or utilize the results.
This bill would state that nothing in those provisions prevents a licensed pharmacist from practicing the profession or occupation for which they are licensed. The bill would also provide that nothing in those provisions authorize any person to perform or order health care services or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide or order that care or utilize the results.
Existing law prohibits the performance of a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of a laboratory director and the test is performed by specified persons, including a pharmacist if ordering drug therapy-related laboratory tests, as provided, or if performing skin puncture, as provided. Existing law exempts from that prohibition a pharmacist at a community pharmacy who, upon customer request, performs only specified tests that are classified as waived under the CLIA and are approved by the federal Food and Drug Administration (FDA) for specified purposes, and meets specified requirements. requirements, including that for purposes of the CLIA that the person identified as responsible for directing and supervising testing oversight and decisionmaking be the pharmacist-in-charge.
This bill would revise and expand the types of persons that may perform those tests, including licensed pharmacists if the results of the tests can be lawfully utilized within their practice. practice, and would make conforming changes. The bill would broaden the exemption by providing that the above-described prohibition does not apply to a licensed pharmacist who, upon patient request or hospital authorization, performs tests that are classified as waived under the CLIA or are approved or authorized by the FDA, and meets specified requirements. The bill would remove the requirement that for purposes of the CLIA that person identified as responsible for directing and supervising testing oversight and decisionmaking be the pharmacist-in-charge.
(2) Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists by the California State Board of Pharmacy in the Department of Consumer Affairs. That law makes it a misdemeanor for any person to knowingly violate any of the provisions of that law when no other penalty is provided. That law authorizes a pharmacist to order and interpret tests, among other things, for the purpose of monitoring and managing the efficacy and toxicity of drug therapies.
This bill would authorize a pharmacist to order and interpret tests for the purpose of promoting patient health.
The Pharmacy Law also authorizes a pharmacist to perform specified procedures or functions as part of the care provided by certain facilities or persons, as provided, in accordance with the policies, procedures, or protocols of those facilities or persons. Under existing law, those procedures or functions include ordering or performing routine drug therapy-related patient assessment procedures, ordering screening or drug therapy-related tests, and administering drugs and biologicals by injection pursuant to a prescriber’s order. Existing law requires the policies, procedures, or protocols to include, among other things, a requirement that those procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a physician.
This bill would expand the procedures or functions that a pharmacist may perform as part of the care provided by certain facilities or persons, as provided, including by authorizing a pharmacist to order or perform patient assessment procedures. The bill would revise the requirements relating to the policies, procedures, or protocols by requiring that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a diagnosing or treating prescriber.
Existing law authorizes a pharmacist to perform skin puncture in the course of performing routine patient assessment procedures or other specified procedures. Existing law defines routine patient assessment procedure as a procedure that a patient could, with or without a prescription, perform for themselves, or clinical laboratory tests that are classified as waived pursuant to the CLIA, as provided.
This bill would remove from the definition of routine patient assessment procedures a procedure that a patient could, with or without a prescription, perform for themselves. By expanding the scope of 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 1206 of the Business and Professions Code is amended to read:

1206.
 (a) For the purposes of this chapter the following definitions are applicable:
(1) “Analyte” means the substance or constituent being measured including, but not limited to, glucose, sodium, or theophyline, or any substance or property whose presence or absence, concentration, activity, intensity, or other characteristics are to be determined.
(2) “Biological specimen” means any material that is derived from the human body.
(3) “Blood electrolyte analysis” means the measurement of electrolytes in a blood specimen by means of ion selective electrodes on instruments specifically designed and manufactured for blood gas and acid-base analysis.
(4) “Blood gas analysis” means a clinical laboratory test or examination that deals with the uptake, transport, and metabolism of oxygen and carbon dioxide in the human body.
(5) “Clinical laboratory test or examination” means the detection, identification, measurement, evaluation, correlation, monitoring, and reporting of any particular analyte, entity, or substance within a biological specimen for the purpose of obtaining scientific data which may be used as an aid to ascertain the presence, progress, and source of a disease or physiological condition in a human being, or used as an aid in the prevention, prognosis, monitoring, or treatment of a physiological or pathological condition in a human being, or for the performance of nondiagnostic tests for assessing the health of an individual.
(6) “Clinical laboratory science” means any of the sciences or scientific disciplines used to perform a clinical laboratory test or examination.
(7) “Clinical laboratory practice” means the application of clinical laboratory sciences or the use of any means that applies the clinical laboratory sciences within or outside of a licensed or registered clinical laboratory. Clinical laboratory practice includes consultation, advisory, and other activities inherent to the profession.
(8) “Clinical laboratory” means any place used, or any establishment or institution organized or operated, for the performance of clinical laboratory tests or examinations or the practical application of the clinical laboratory sciences. That application may include any means that applies the clinical laboratory sciences.
(9) “Direct and constant supervision” means personal observation and critical evaluation of the activity of unlicensed laboratory personnel by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the unlicensed laboratory personnel are engaged in the duties specified in Section 1269.
(10) “Direct and responsible supervision” means both of the following:
(A) Personal observation and critical evaluation of the activity of a trainee by a physician and surgeon, or by a person licensed under this chapter other than a trainee, during the entire time that the trainee is performing clinical laboratory tests or examinations.
(B) Personal review by the physician and surgeon or the licensed person of all results of clinical laboratory testing or examination performed by the trainee for accuracy, reliability, and validity before the results are reported from the laboratory.
(11) “Licensed laboratory” means a clinical laboratory licensed pursuant to paragraph (1) of subdivision (a) of Section 1265.
(12) “Location” means either a street and city address, or a site or place within a street and city address, where any of the clinical laboratory sciences or scientific disciplines are practiced or applied, or where any clinical laboratory tests or examinations are performed.
(13) “Physician office laboratory” means a clinical laboratory that is licensed or registered under Section 1265, and that is either: (A) a clinical laboratory that is owned and operated by a partnership or professional corporation that performs clinical laboratory tests or examinations only for patients of five or fewer physicians and surgeons or podiatrists who are shareholders, partners, or employees of the partnership or professional corporation that owns and operates the clinical laboratory; or (B) a clinical laboratory that is owned and operated by an individual licensed physician and surgeon or a podiatrist, and that performs clinical laboratory tests or examinations only for patients of the physician and surgeon or podiatrist who owns and operates the clinical laboratory.
(14) “Point-of-care laboratory testing device” means a portable laboratory testing instrument to which the following applies:
(A) It is used within the proximity of the patient for whom the test or examination is being conducted.
(B) It is used in accordance with the patient test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220.
(C) It meets the following criteria:
(i) Performs clinical laboratory tests or examinations classified as waived or of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
(ii) Performs clinical laboratory tests or examinations on biological specimens that require no preparation after collection.
(iii) Provides clinical laboratory tests or examination results without calculation or discretionary intervention by the testing personnel.
(iv) Performs clinical laboratory tests or examinations without the necessity for testing personnel to perform calibration or maintenance, except resetting pursuant to the manufacturer’s instructions or basic cleaning.
(15) “Public health laboratory” means a laboratory that is operated by a city or county in conformity with Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code and the regulations adopted thereunder.
(16) “Registered laboratory” means a clinical laboratory registered pursuant to paragraph (2) of subdivision (a) of Section 1265.
(17) “Specialty” means histocompatibility, microbiology, diagnostic immunology, chemistry, hematology, immunohematology, pathology, genetics, or other specialty specified by regulation adopted by the department.
(18) “Subspecialty” for purposes of microbiology, means bacteriology, mycobacteriology, mycology, parasitology, virology, molecular biology, and serology for diagnosis of infectious diseases, or other subspecialty specified by regulation adopted by the department; for purposes of diagnostic immunology, means syphilis serology, general immunology, or other subspecialty specified by regulation adopted by the department; for purposes of chemistry, means routine chemistry, clinical microscopy, endocrinology, toxicology, or other subspecialty specified by regulation adopted by the department; for purposes of immunohematology, means ABO/Rh Type and Group, antibody detection for transfusion, antibody detection nontransfusion, antibody identification, compatibility, or other subspecialty specified by regulation adopted by the department; for pathology, means tissue pathology, oral pathology, diagnostic cytology, or other subspecialty specified by regulation adopted by the department; for purposes of genetics, means molecular biology related to the diagnosis of human genetic abnormalities, cytogenetics, or other subspecialty specified by regulation adopted by the department.
(b) Nothing in this chapter shall restrict, limit, or prevent any person licensed to provide health care services under the laws of this state, including, but not limited to, licensed physicians and surgeons, licensed pharmacists, and registered nurses, from practicing the profession or occupation for which he or she is licensed.
(c) Nothing in this chapter shall authorize any person to perform or order health care services, or utilize the results of the clinical laboratory test or examination, unless the person is otherwise authorized to provide or order that care or utilize the results. The inclusion of a person in Section 1206.5 for purposes of performing a clinical laboratory test or examination shall not be interpreted to authorize a person, who is not otherwise authorized, to perform venipuncture, arterial puncture, or skin puncture.

SEC. 2.

 Section 1206.5 of the Business and Professions Code is amended to read:

1206.5.
 (a) Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Sections 1206.6 and 1241, no person shall perform a clinical laboratory test or examination classified as waived under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O. degree.
(2) A licensed podiatrist, a licensed dentist, licensed pharmacist, or a licensed naturopathic doctor, if the results of the tests can be lawfully utilized within his or her their practice.
(3) A person licensed under this chapter to engage in clinical laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate issued under Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising physician and surgeon in accordance with Section 3502 or 3535, or a licensed intern pharmacist, if authorized by the supervising pharmacist on site.
(6) A person licensed under Chapter 6 (commencing with Section 2700).
(7) A person licensed under Chapter 6.5 (commencing with Section 2840).
(8) A perfusionist if authorized by and performed in compliance with Section 2590.
(9) A respiratory care practitioner if authorized by and performed in compliance with Chapter 8.3 (commencing with Section 3700).
(10) A medical assistant, as defined in Section 2069, if the waived test is performed pursuant to a specific authorization meeting the requirements of Section 2069.

(11)A pharmacist, as defined in Section 4036, if the results of the tests can be lawfully utilized within their practice, if ordering drug therapy-related laboratory tests in compliance with paragraph (2) of subdivision (a) of Section 4052.1 or paragraph (2) of subdivision (a) of Section 4052.2, or if performing skin puncture in the course of performing routine public health or standard of care patient assessment services in compliance with Section 4050 or 4052.1.

(12)

(11) A naturopathic assistant, as defined in Sections 3613 and 3640.2, if the waived test is performed pursuant to a specific authorization meeting the requirements of Sections 3613 and 3640.2.

(13)

(12) A licensed optometrist as authorized under Chapter 7 (commencing with Section 3000).

(14)A pharmacist, as defined in Section 4036, if ordering drug therapy-related laboratory tests in compliance with paragraph (2) of subdivision (a) of Section 4052.1 or paragraph (2) of subdivision (a) of Section 4052.2.

(15)

(13) Other health care personnel providing direct patient care.

(16)

(14) Any other person performing nondiagnostic testing pursuant to Section 1244.
(b) Notwithstanding subdivision (b) of Section 1206, no person shall perform clinical laboratory tests or examinations classified as of moderate complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O. degree.
(2) A licensed podiatrist or a licensed dentist if the results of the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical laboratory practice or to direct a clinical laboratory.
(4) A person authorized to perform tests pursuant to a certificate issued under Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code.
(5) A licensed physician assistant if authorized by a supervising physician and surgeon in accordance with Section 3502 or 3535.
(6) A person licensed under Chapter 6 (commencing with Section 2700).
(7) A perfusionist if authorized by and performed in compliance with Section 2590.
(8) A respiratory care practitioner if authorized by and performed in compliance with Chapter 8.3 (commencing with Section 3700).
(9) A person performing nuclear medicine technology if authorized by and performed in compliance with Article 6 (commencing with Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health and Safety Code.
(10) Any person if performing blood gas analysis in compliance with Section 1245.
(11) (A) A person certified or licensed as an “Emergency Medical Technician II” or paramedic pursuant to Division 2.5 (commencing with Section 1797) of the Health and Safety Code while providing prehospital medical care, a person licensed as a psychiatric technician under Chapter 10 (commencing with Section 4500) of Division 2, as a vocational nurse pursuant to Chapter 6.5 (commencing with Section 2840), or as a midwife licensed pursuant to Article 24 (commencing with Section 2505) of Chapter 5, or certified by the department pursuant to Division 5 (commencing with Section 70001) of Title 22 of the California Code of Regulations as a nurse assistant or a home health aide, who provides direct patient care, if the person is performing the test as an adjunct to the provision of direct patient care by the person, is utilizing a point-of-care laboratory testing device at a site for which a laboratory license or registration has been issued, meets the minimum clinical laboratory education, training, and experience requirements set forth in regulations adopted by the department, and has demonstrated to the satisfaction of the laboratory director that he or she is competent in the operation of the point-of-care laboratory testing device for each analyte to be reported.
(B) Prior to being authorized by the laboratory director to perform laboratory tests or examinations, testing personnel identified in subparagraph (A) shall participate in a preceptor program until they are able to perform the clinical laboratory tests or examinations authorized in this section with results that are deemed accurate and skills that are deemed competent by the preceptor. For the purposes of this section, a “preceptor program” means an organized system that meets regulatory requirements in which a preceptor provides and documents personal observation and critical evaluation, including review of accuracy, reliability, and validity, of laboratory testing performed.
(12) Any other person within a physician office laboratory if the test is performed under the supervision of the patient’s physician and surgeon or podiatrist who shall be accessible to the laboratory to provide onsite, telephone, or electronic consultation as needed, and shall: (A) ensure that the person is performing test methods as required for accurate and reliable tests; and (B) have personal knowledge of the results of the clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory.
(13) A pharmacist, if ordering drug therapy-related laboratory tests in compliance with paragraph (2) of subdivision (a) of Section 4052.1 or paragraph (2) of subdivision (a) of Section 4052.2.
(c) Notwithstanding subdivision (b) of Section 1206, no person shall perform clinical laboratory tests or examinations classified as of high complexity under CLIA unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director, as described in Section 1209, including, but not limited to, documentation by the laboratory director of the adequacy of the qualifications and competency of the personnel, and the test is performed by any of the following persons:
(1) A licensed physician and surgeon holding a M.D. or D.O. degree.
(2) A licensed podiatrist or a licensed dentist if the results of the tests can be lawfully utilized within his or her practice.
(3) A person licensed under this chapter to engage in clinical laboratory practice or to direct a clinical laboratory if the test or examination is within a specialty or subspecialty authorized by the person’s licensure.
(4) A person authorized to perform tests pursuant to a certificate issued under Article 5 (commencing with Section 101150) of Chapter 2 of Part 3 of Division 101 of the Health and Safety Code if the test or examination is within a specialty or subspecialty authorized by the person’s certification.
(5) A licensed physician assistant if authorized by a supervising physician and surgeon in accordance with Section 3502 or 3535.
(6) A perfusionist if authorized by and performed in compliance with Section 2590.
(7) A respiratory care practitioner if authorized by and performed in compliance with Chapter 8.3 (commencing with Section 3700).
(8) A person performing nuclear medicine technology if authorized by and performed in compliance with Article 6 (commencing with Section 107150) of Chapter 4 of Part 1 of Division 104 of the Health and Safety Code.
(9) Any person if performing blood gas analysis in compliance with Section 1245.
(10) Any other person within a physician office laboratory if the test is performed under the onsite supervision of the patient’s physician and surgeon or podiatrist who shall: (A) ensure that the person is performing test methods as required for accurate and reliable tests; and (B) have personal knowledge of the results of clinical laboratory testing or examination performed by that person before the test results are reported from the laboratory.
(d) Clinical laboratory examinations classified as provider-performed microscopy under CLIA may be personally performed using a brightfield or phase/contrast microscope by one of the following practitioners:
(1) A licensed physician and surgeon using the microscope during the patient’s visit on a specimen obtained from his or her own patient or from a patient of a group medical practice of which the physician is a member or employee.
(2) A nurse midwife holding a certificate as specified by Section 2746.5, a licensed nurse practitioner as specified in Section 2835.5, or a licensed physician assistant acting under the supervision of a physician pursuant to Section 3502 using the microscope during the patient’s visit on a specimen obtained from his or her own patient or from the patient of a clinic, group medical practice, or other health care provider of which the certified nurse midwife, licensed nurse practitioner, or licensed physician assistant is an employee.
(3) A licensed dentist using the microscope during the patient’s visit on a specimen obtained from his or her own patient or from a patient of a group dental practice of which the dentist is a member or an employee.

SEC. 3.

 Section 1206.6 of the Business and Professions Code is amended to read:

1206.6.
 Subdivision (a) of Section 1206.5 shall not apply to a licensed pharmacist who, upon patient request or hospital authorization, performs tests that are classified as waived under CLIA or are approved or authorized by the federal Food and Drug Administration, provided that all of the following requirements are satisfied:
(a) The hospital, clinic, or pharmacy where the pharmacist practices, or the pharmacist, obtains a valid CLIA certificate of waiver and complies with all other requirements for the performance of waived clinical laboratory tests under applicable federal regulations. For purposes of CLIA, the person identified as responsible for directing and supervising testing oversight and decisionmaking shall be the pharmacist-in-charge, as defined in Section 4036.5.
(b) The hospital, clinic, or pharmacy where the pharmacist practices, or the pharmacist, obtains a registration from the department pursuant to Section 1265 and complies with this chapter.

SEC. 4.

 Section 4050 of the Business and Professions Code is amended to read:

4050.
 (a) In recognition of and consistent with the decisions of the appellate courts of this state, the Legislature hereby declares the practice of pharmacy to be a profession.
(b) Pharmacy practice is a dynamic, patient- and public health-oriented health service that applies a scientific body of knowledge to improve and promote patient and public health by means of appropriate drug use, drug-related therapy, health screenings, and communication for clinical and consultative purposes. Pharmacy practice is continually evolving to include more sophisticated and comprehensive patient care and public health activities.
(c) The Legislature further declares that pharmacists are health care providers who have the authority to provide health care services.

SEC. 5.

 Section 4052 of the Business and Professions Code is amended to read:

4052.
 (a) Notwithstanding any other law, a pharmacist may:
(1) Furnish a reasonable quantity of compounded drug product to a prescriber for office use by the prescriber.
(2) Transmit a valid prescription to another pharmacist.
(3) Administer drugs and biological products that have been ordered by a prescriber.
(4) Perform procedures or functions in a licensed health care facility as authorized by Section 4052.1.
(5) Perform procedures or functions as part of the care provided by a health care facility, a licensed home health agency, a licensed clinic in which there is a physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, as authorized by Section 4052.2.
(6) Perform procedures or functions as authorized by Section 4052.6.
(7) Manufacture, measure, fit to the patient, or sell and repair dangerous devices, or furnish instructions to the patient or the patient’s representative concerning the use of those devices.
(8) Provide consultation, training, and education to patients about drug therapy, disease management, and disease prevention.
(9) Provide professional information, including clinical or pharmacological information, advice, or consultation to other health care professionals, and participate in multidisciplinary review of patient progress, including appropriate access to medical records.
(10) Furnish the medications described in subparagraph (A) in accordance with subparagraph (B):
(A) (i) Emergency contraception drug therapy and self-administered hormonal contraceptives, as authorized by Section 4052.3.
(ii) Nicotine replacement products, as authorized by Section 4052.9.
(iii) Prescription medications not requiring a diagnosis that are recommended by the federal Centers for Disease Control and Prevention for individuals traveling outside of the United States.
(iv) HIV preexposure prophylaxis, as authorized by Section 4052.02.
(v) HIV postexposure prophylaxis, as authorized by Section 4052.03.
(B) The pharmacist shall notify the patient’s primary care provider of any drugs or devices furnished to the patient, or enter the appropriate information in a patient record system shared with the primary care provider, as permitted by that primary care provider. If the patient does not have a primary care provider, the pharmacist shall provide the patient with a written record of the drugs or devices furnished and advise the patient to consult a physician of the patient’s choice.
(11) Administer immunizations pursuant to a protocol with a prescriber.
(12) Order and interpret tests for the purpose of promoting patient health and monitoring and managing the efficacy and toxicity of drug therapies. A pharmacist who orders and interprets tests pursuant to this paragraph shall ensure that the ordering of those tests is done in coordination with the patient’s primary care provider or diagnosing prescriber, as appropriate, including promptly transmitting written notification to the patient’s diagnosing prescriber or entering the appropriate information in a patient record system shared with the prescriber, when available and as permitted by that prescriber.
(b) A pharmacist who is authorized to issue an order to initiate or adjust a controlled substance therapy pursuant to this section shall personally register with the federal Drug Enforcement Administration.
(c) This section does not affect the applicable requirements of law relating to either of the following:
(1) Maintaining the confidentiality of medical records.
(2) The licensing of a health care facility.

SEC. 6.

 Section 4052.2 of the Business and Professions Code is amended to read:

4052.2.
 (a) Notwithstanding any other law, a pharmacist may perform the following procedures or functions as part of the care provided by a health care facility, a licensed home health agency, licensed correctional clinic, a licensed clinic in which there is physician oversight, a provider who contracts with a licensed health care service plan with regard to the care or services provided to the enrollees of that health care service plan, or a physician, in accordance with the policies, procedures, or protocols of that facility, home health agency, licensed correctional clinic, licensed clinic, health care service plan, or physician, and in accordance with subdivision (c):
(1) Ordering or performing patient assessment procedures, including, but not limited to, temperature, pulse, and respiration.
(2) Ordering health screenings or drug therapy-related laboratory tests.
(3) Administering drugs and biologicals that have been ordered by a prescriber.
(4) Initiating or adjusting the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient’s treating prescriber, and in accordance with the policies, procedures, or protocols of the health care facility, home health agency, licensed correctional clinic, licensed clinic, health care service plan, or physician. Adjusting the drug regimen does not include substituting or selecting a different drug, except as authorized by the protocol. The pharmacist shall provide written notification to the patient’s treating prescriber, or enter the appropriate information in an electronic patient record system shared by the prescriber, of any drug regimen initiated pursuant to this paragraph within 24 hours.
(b) A patient’s treating prescriber may prohibit, by written instruction, any adjustment or change in the patient’s drug regimen by the pharmacist.
(c) The policies, procedures, or protocols referred to in this subdivision shall be developed by health care professionals, including physicians, pharmacists, and registered nurses, and shall, at a minimum, do all of the following:
(1) Require that the pharmacist function as part of a multidisciplinary group that includes physicians and direct care registered nurses. The multidisciplinary group shall determine the appropriate participation of the pharmacist and the direct care registered nurse.
(2) Require that the medical records of the patient be available to both the patient’s treating prescriber and the pharmacist.
(3) Require that the procedures to be performed by the pharmacist relate to a condition for which the patient has first been seen by a diagnosing or treating prescriber.
(4) Except for procedures or functions provided by a health care facility, a licensed correctional clinic, as defined in Section 4187, a licensed clinic in which there is physician oversight, or a provider who contracts with a licensed health care plan with regard to the care or services provided to the enrollees of that health care service plan, require the procedures to be performed in accordance with a written, patient-specific protocol approved by the treating or supervising physician. Any change, adjustment, or modification of an approved preexisting treatment or drug therapy shall be provided in writing to the treating or supervising physician within 24 hours.
(d) Prior to performing any procedure authorized by this section, a pharmacist shall have done either of the following:
(1) Successfully completed clinical residency training.
(2) Demonstrated clinical experience in direct patient care delivery.

SEC. 7.

 Section 4052.4 of the Business and Professions Code is amended to read:

4052.4.
 Notwithstanding Section 2038 or any other provision of law, a pharmacist may perform skin puncture in the course of performing routine patient assessment procedures or in the course of performing any procedure authorized under Section 1206.5 or 1206.6. For purposes of this section, “routine patient assessment procedures” means clinical laboratory tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, as authorized by paragraph (11) (2) of subdivision (a) of Section 1206.5 or Section 1206.6. A pharmacist performing these functions shall report the results obtained from a test to the patient and any physician prescriber designated by the patient. Any pharmacist who performs the service authorized by this section shall not be in violation of Section 2052.

SEC. 8.

 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.