Bill Text: CA AB1328 | 2021-2022 | Regular Session | Amended
Bill Title: Clinical laboratory technology and pharmacists.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Engrossed - Dead) 2022-08-31 - Ordered to inactive file at the request of Senator Leyva. [AB1328 Detail]
Download: California-2021-AB1328-Amended.html
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Amended
IN
Senate
July 14, 2021 |
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Amended
IN
Assembly
April 21, 2021 |
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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, 1265, 4050, 4052, 4052.2, and 4052.4 of, and to add Section 1206.7 to, the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
AB 1328, as amended, Irwin.
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 authorizes 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, 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, except as provided, if the results of the tests can be lawfully utilized within their 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. The bill would make conforming changes.
(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.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YESBill Text
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 they are 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
an M.D. or D.O. degree.
(2) Except as provided in Section 1206.7, a licensed podiatrist, a licensed dentist, licensed pharmacist, or a licensed naturopathic doctor, if the results of the tests can be lawfully utilized within 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 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.
(12) A licensed optometrist as authorized under Chapter 7 (commencing with Section 3000).
(13) Other health care personnel providing direct patient care.
(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 an 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
the licensee’s 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 they are 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
an 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 the licensee’s 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 their 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
their 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 the dentist’s 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, pharmacy, or the location where the pharmacist provides care, 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.
regulations, including, but not limited to, Sections 493.1251 and 493.1291 of Title 42 of the Code of Federal Regulations.
(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.
(c)The pharmacist notifies the patient’s primary care provider, or other appropriate physician and surgeon, of any abnormal test results. If the patient does not have a primary care provider, or refuses consent to notify the patient’s primary care provider, the pharmacist shall provide the patient a list of physicians and
surgeons, clinics, or other health care service providers to contact regarding ongoing care for the abnormal test results.
(c) The pharmacist provides the patient with a written record of the test results. Upon consent of the patient, the pharmacist shall provide the test results to the patient’s primary care provider or enter the test results into a patient medical record shared with the primary care provider, as permitted by that primary care provider.
(1) The pharmacist shall maintain a record of the information delivered to the patient’s primary care provider.
(2) If the patient does not have a primary care provider, or refuses consent to notify the primary care provider, the pharmacist shall
provide the patient a list of physicians and surgeons, clinics, or other health care service providers to contact regarding care for abnormal results.
(d) Specimen collection is performed onsite or by self-collection off site and delivered to the location noted on the CLIA certificate of waiver by the patient or the patient’s agent. If specimen collection is done onsite, it may be performed by the patient. A patient performing an onsite specimen collection shall be provided a dedicated space that provides for privacy during the specimen collection, testing process, and consultation with the pharmacist.
SEC. 4.
Section 1206.7 is added to the Business and Professions Code, to read:1206.7.
(a) A licensed pharmacist shall not perform(b) A licensed pharmacist shall not perform clinical laboratory tests or examinations classified as waived
under CLIA that are utilized for purposes of any of the following:
(a)
(1) Surgery.
(b)
(2) Diagnosis or treatment
of heart failure.
(c)Female fertility.
(3) Fertility.
(d)
(4) Ovulation prediction.
SEC. 5.
Section 1265 of the Business and Professions Code is amended to read:1265.
(a) (1) A clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain a clinical laboratory license pursuant to this chapter. The department shall issue a clinical laboratory license to any person who has applied for the license on forms provided by the department and who is found to be in compliance with this chapter and the regulations pertaining thereto. No clinical laboratory license shall be issued by the department unless the clinical laboratory and its personnel meet the CLIA requirements for laboratories performing tests or examinations classified as of moderate or high complexity, or both.(2) A clinical laboratory performing clinical laboratory tests or examinations subject to a certificate of waiver or a certificate of provider-performed microscopy under CLIA, shall register with the department. The department shall issue a clinical laboratory registration to any person who has applied for the registration on forms provided by the department and is found to be in compliance with this chapter, the regulations pertaining thereto, and the CLIA requirements for either a certificate of waiver or a certificate of provider-performed microscopy.
(b) An application for a clinical laboratory license or registration shall include the name or names of the owner or the owners, the name or names of the laboratory director or directors, the name and location of the laboratory, a list of the clinical laboratory tests or
examinations performed by the laboratory by name and total number of test procedures and examinations performed annually (excluding tests the laboratory may run for quality control, quality assurance, or proficiency testing purposes). The application shall also include a list of the tests and the test kits, methodologies, and laboratory equipment used, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and test procedures, and any other relevant information as may be required by the department. If the laboratory is performing tests subject to a provider-performed microscopy certificate, the name of the provider or providers performing those tests shall be included on the application. Application shall be made by the owners of the laboratory and the laboratory directors prior to
its opening. A license or registration to conduct a clinical laboratory if the owners are not the laboratory directors shall be issued jointly to the owners and the laboratory directors and the license or registration shall include any information as may be required by the department. The owners and laboratory directors shall be severally and jointly responsible to the department for the maintenance and conduct thereof or for any violations of this chapter and regulations pertaining thereto.
(c) The department shall not issue a license or registration until it is satisfied that the clinical laboratory will be operated within the spirit and intent of this chapter, that the owners and laboratory directors are each of good moral character, and that the granting of the license will not be in conflict with the interests of public health.
(d) A separate license or registration shall be obtained for each laboratory location, with the following exceptions:
(1) Laboratories that are not at a fixed location, that is, laboratories that move from one testing site to another, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations, may apply for and obtain one license or registration for the designated primary site or home base, using the address of that primary site.
(2) Not-for-profit, or federal, state, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests, as defined under CLIA, per license) public health testing may apply for and obtain
a single license or registration.
(3) Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction, may file a single application or multiple applications for a license or registration of laboratory locations within the same campus or street address.
(4) Locations within a single street and city address that are under common ownership may apply for and obtain a single license or registration or multiple licenses or registrations, at the discretion of the owner or owners.
(e) (1) A license or registration shall be valid for one year unless revoked or suspended. A clinical laboratory license or registration shall be automatically revoked 30
days from a major change of laboratory directorship or ownership. The clinical laboratory shall be required to submit a completed application for a new clinical laboratory license or registration within those 30 days or cease engaging in clinical laboratory practice.
(2) If a clinical laboratory intends to continue to engage in clinical laboratory practice during the 30 days after a major change in directorship occurs and before the laboratory license or registration is automatically revoked, the laboratory owner may appoint an interim director who meets the requirements of this chapter and CLIA. The interim director shall be appointed within five business days of the major change of the directorship. Written notice shall be provided to the department of the appointment of the laboratory director pursuant to this paragraph within five business
days of the appointment.
(f) If the department does not within 60 days after the date of receipt of the application issue a license or registration, it shall state the grounds and reasons for its refusal in writing, serving a copy upon the applicant by certified mail addressed to the applicant at his or her the applicant’s last known address.
(g) The department shall be notified in writing by the laboratory owners or delegated representatives of the owners and the laboratory directors of any change in ownership, directorship, name, or location, including the addition or deletion of laboratory owners or laboratory
directors within 30 days. However, notice of change in ownership shall be the responsibility of both the current and new owners. Laboratory owners and directors to whom the current license or registration is issued shall remain jointly and severally responsible to the department for the operation, maintenance, and conduct of the clinical laboratory and for any violations of this chapter or the regulations adopted thereunder, including any failure to provide the notifications required by this subdivision, until proper notice is received by the department. In addition, failure of the laboratory owners and directors to notify the department within 30 days of any change in laboratory directors, including any additions or deletions, shall result in the automatic revocation of the clinical laboratory’s license or registration.
(h) The
withdrawal of an application for a license or registration or for a renewal of a license, or registration, issuable under this chapter, shall not, after the application has been filed with the department, deprive the department of its authority to institute or continue a proceeding against the applicant for denial of the license, registration, or renewal upon any ground provided by law or to enter an order denying the license, registration, or renewal upon any such ground, unless the department consents in writing to the withdrawal.
(i) The suspension, expiration, or forfeiture by operation of law of a license or registration issued under this chapter, or its suspension, forfeiture, or cancellation by order of the department or by order of a court of law, or its surrender without the written consent of the department, shall not deprive the
department of its authority to institute or continue an action against a license or registration issued under this chapter or against the laboratory owner or laboratory director upon any ground provided by law or to enter an order suspending or revoking the license or registration issued under this chapter.
(j) (1) Whenever a clinical laboratory ceases operations, the laboratory owners, or delegated representatives of the owners, and the laboratory directors shall notify the department of this fact, in writing, within 30 calendar days from the date a clinical laboratory ceases operation. For purposes of this subdivision, a laboratory ceases operations when it suspends the performance of all clinical laboratory tests or examinations for 30 calendar days at the location for which the clinical laboratory is licensed or
registered.
(2) (A) Notwithstanding any other provision of law, owners and laboratory directors of all clinical laboratories, including those laboratories that cease operations, shall preserve medical records and laboratory records, as defined in this section, for three years from the date of testing, examination, or purchase, unless a longer retention period is required pursuant to any other provision of law, and shall maintain an ability to provide those records when requested by the department or any duly authorized representative of the department.
(B) For purposes of this subdivision, “medical records” means the test requisition or test authorization, or the patient’s chart or medical record, if used as the test requisition, the final and preliminary
test or examination result, and the name of the person contacted if the laboratory test or examination result indicated an imminent life-threatening result or was of panic value.
(C) For purposes of this subdivision, “laboratory records” means records showing compliance with CLIA and this chapter during a
laboratory’s operation that are actual or true copies, either photocopies or electronically reproducible copies, of records for patient test management, quality control, quality assurance, and all invoices documenting the purchase or lease of laboratory equipment and test kits, reagents, or media.
(D) Information contained in medical records and laboratory records shall be confidential, and shall be disclosed only to authorized persons in accordance with federal, state, and local laws.
(3) The department or any person injured as a result of a laboratory’s abandonment or failure to retain records pursuant to this section may bring an action in a court of proper jurisdiction for any reasonable amount of damages suffered as a result thereof.
(k) For purposes of this section, in the case of a pharmacy that applies for a registration pursuant to Section 1206.6, “laboratory director” means the pharmacist-in-charge identified on the CLIA certificate of waiver, as described in subdivision (a) of Section 1206.6.
SEC. 6.
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. 7.
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. 8.
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.
