Bill Text: CA SB667 | 2023-2024 | Regular Session | Amended

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Healing arts: pregnancy and childbirth.

Spectrum: Partisan Bill (Democrat 2-0)

Status: (Passed) 2023-10-08 - Chaptered by Secretary of State. Chapter 497, Statutes of 2023. [SB667 Detail]

Download: California-2023-SB667-Amended.html

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Amended  IN  Senate  April 19, 2023

Amended  IN  Senate  April 11, 2023

CALIFORNIA LEGISLATURE— 2023–2024 REGULAR SESSION

Senate Bill

No. 667

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Introduced by Senator Dodd

February 16, 2023

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An act to amend Sections 1206.5, 1265, 1209, 2746.5, 2746.51, and 4170 of, and to add Section 1206.8 to, of the Business and Professions Code, and to amend Section 2708 of the Unemployment Insurance Code, relating to healing arts.

LEGISLATIVE COUNSEL'S DIGEST

SB 667, as amended, Dodd. Healing arts: pregnancy and childbirth.

(1) Existing law, the Nursing Practice Act, establishes the Board of Registered Nursing within the Department of Consumer Affairs for the licensure and regulation of the practice of nursing. A violation of the act is a crime. Existing law requires the board to issue a certificate to practice nurse-midwifery to a person who meets specified qualifications. Existing law authorizes a certified nurse-midwife to attend cases of low-risk pregnancy and childbirth and to provide prenatal, intrapartum, and postpartum care, including interconception care, family planning care, and immediate care for the newborn, as specified. Existing law authorizes a certified nurse-midwife to practice with a physician and surgeon under mutually agreed-upon policies and protocols, as specified, to provide a patient with care outside of that scope of services or to provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium.

This bill would revise and recast those provisions to, among other things, authorize a certified nurse-midwife, pursuant to policies and protocols that are mutually agreed upon with a physician and surgeon, as specified, to provide a patient with care outside of that scope of services or to provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium. The bill would include care for common gynecologic conditions, as specified, in the scope of services a certified nurse-midwife is authorized to perform without policies and protocols that are mutually agreed upon with a physician and surgeon. The bill would additionally authorize a hospital, as defined, to grant privileges to a certified nurse-midwife, allowing them to admit and discharge patients upon their own authority if in accordance with the bylaws of that facility and within the nurse-midwife’s scope of practice.

Existing law generally authorizes a certified nurse-midwife to furnish drugs or devices incidentally to the provision of care and services described above that the certified nurse-midwife is authorized to perform and care rendered to persons within certain settings, subject to specified requirements and exceptions. Among those requirements is that a certified nurse-midwife follow standardized procedures or protocols if they furnish or order Schedule IV or V controlled substances or drugs or devices for services other than attending cases of low-risk pregnancy and childbirth or providing prenatal, intrapartum, and postpartum care, as specified. Existing law requires those standardized procedures or protocols to specify which nurse-midwife is authorized to furnish or order drugs or devices, which drugs or devices may be furnished or ordered and under what circumstances, and the method of periodic review of the certified nurse-midwife’s competence, as specified, and review of the provisions of the standardized procedure. Existing law requires a certified nurse-midwife to follow a patient-specific protocol approved by a physician and surgeon if the certified nurse-midwife furnishes or orders Schedule II or III controlled substances for any condition. Existing law requires the patient-specific protocol to address the diagnosis of the illness, injury, or condition for which a Schedule II controlled substance is to be furnished.

This bill would revise and recast those provisions to remove references to standardized procedures or protocols. Instead, the bill would require the above-described policies and protocols that a certified nurse-midwife is required to follow for certain care to contain provisions governing the furnishing or ordering of drugs or devices for services other than attending cases of low-risk pregnancy and childbirth or providing prenatal, intrapartum, and postpartum care, as specified. The bill would additionally require those policies and protocols to contain a patient-specific protocol that identifies the patient conditions for which a certified nurse-midwife is authorized to furnish or order a Schedule II or III controlled substance.

Existing law authorizes a certified nurse-midwife to procure supplies and devices, obtain and administer diagnostic tests, obtain and administer nonscheduled drugs consistent with the provision of services authorized to be performed without policies and protocols mutually agreed upon with a physician and surgeon, order laboratory and diagnostic testing, and receive reports, as specified. Existing law imposes various requirements on a prescriber, as defined, for dispensing drugs and dangerous devices, including that the drug or device is necessary in the treatment of the condition for which the prescriber is attending the patient.

This bill would additionally authorize a certified nurse-midwife to dispense drugs when attending cases of low-risk pregnancy and childbirth or providing prenatal care, intrapartum care, postpartum care, or care for common gynecologic conditions, pursuant to the above-described requirements on prescribers. The bill would add a certified nurse-midwife to the definition of “prescriber” for purposes of those requirements.

(2) Existing law prohibits, except as specified, a person from performing a clinical laboratory test or examination classified as waived or classified as of moderate complexity under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) unless the test or examination is performed under the overall operation and administration of the laboratory director, as specified. Existing law defines laboratory director for this purpose.

This bill would, notwithstanding that prohibition, authorize an alternative birth center or primary care clinic, as defined, to perform would amend the definition of laboratory director to include a nurse-midwife serving as a director of a laboratory that performs only testing and examinations classified as waived or a provider-performed microscopy consistent with services authorized within the scope of the provider’s license, if specified requirements are satisfied. The bill would make conforming changes. nurse-midwife’s certificate to practice.

(3) Existing law requires a claimant for unemployment compensation disability benefits to establish medical eligibility for each uninterrupted period of disability by filing a first claim for disability benefits supported by the certificate of a treating physician or practitioner that establishes the sickness, injury, or pregnancy of the employee, or the condition of the family member that warrants the care of the employee. Existing law defines the term “practitioner” to mean certain healing arts professions, as specified, including, as to normal pregnancy or childbirth, a midwife, nurse-midwife, or nurse practitioner.

This bill would revise the part of the definition of “practitioner” relating to normal pregnancy or childbirth to include, instead, as to low-risk pregnancy and childbirth or postpartum conditions consistent with the scope of their professional licensure, a midwife, nurse-midwife, or nurse practitioner.

Digest Key

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

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Bill Text

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

SECTION 1.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, 1206.8, 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, 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.

(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 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, if performing skin puncture in the course of performing routine patient assessment procedures in compliance with Section 4052.1, or if performing testing as authorized in Section 4052.4.

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

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

(15)Any other person performing nondiagnostic testing pursuant to Section 1244.

(b)Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Section 1206.8, 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 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.

(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 the person is competent in the operation of the point-of-care laboratory testing device for each analyte to be reported.

(B)Before 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 their 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 their own patient or from a patient of a group medical practice of which the physician is a member or employee.

(2)A nurse practitioner practicing pursuant to Section 2837.103 or 2837.104 using the microscope during the patient’s visit on a specimen obtained from their own patient or from a patient of a group nurse practitioner practice of which the nurse practitioner is a member or employee.

(3)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 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.

(4)A licensed dentist using the microscope during the patient’s visit on a specimen obtained from their own patient or from a patient of a group dental practice of which the dentist is a member or an employee.

SEC. 2.Section 1206.8 is added to the Business and Professions Code, immediately following Section 1206.7, to read:

1206.8.

(a)Notwithstanding subdivisions (a) and (b) of Section 1206.5, an alternative birth center or primary care clinic may perform tests classified as waived under CLIA or a provider-performed microscopy (PPM) that are consistent with services within the scope of the provider’s license, if the alternative birth center or primary care clinic obtains a registration from the department pursuant to Section 1265, complies with this chapter, and the following requirements are satisfied:

(1)If performing tests classified as waived, the alternative birth center or primary care clinic shall do both of the following:

(A)The alternative birth center or primary care clinic 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.

(B)For purposes of CLIA, the person identified as responsible for directing and supervising testing oversight and decisionmaking shall be a certified nurse-midwife licensed pursuant to Article 2.5 (commencing with Section 2746) of Chapter 6, a licensed midwife licensed pursuant to Article 24 (commencing with Section 2505) of Chapter 5, or a physician and surgeon licensed pursuant to Chapter 5 (commencing with Section 2000).

(2)If performing a provider-performed microscopy, the alternative birth center or primary care clinic shall do both of the following:

(A)The alternative birth center or primary care clinic obtains a valid CLIA certificate for provider-performed microscopy and complies with the requirements of subdivision (d) of Section 1206.5.

(B)For purposes of CLIA, the person identified as responsible for directing and supervising testing oversight and decisionmaking shall be a certified nurse-midwife licensed pursuant to Article 2.5 (commencing with Section 2746) of Chapter 6 or a physician and surgeon licensed pursuant to Chapter 5 (commencing with Section 2000) of Chapter 5.

(b)For purposes of this section, the following definitions apply:

(1)“Alternative birth center” has the same meaning as that term is defined in Section 1204 of the Heath and Safety Code.

(2)“Primary care clinic” means a primary care clinic described in Section 1204 of the Health and Safety Code that is established as a clinic or office for one or more nurse-midwives, licensed pursuant to Article 2.5 (commencing with Section 2746) of Chapter 6, or midwives, licensed pursuant to Article 24 (commencing with Section 2505) of Chapter 5.

SEC. 3.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 their 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 pursuant to subdivision (a) of Section 1206.6.

(l)For purposes of this section, in the case of an alternative birth center that applies for a registration pursuant to Section 1206.8, “laboratory director” means the person identified as the responsible party for directing and supervising testing oversight for the purpose of obtaining a CLIA certificate pursuant to Section 1206.8.

SECTION 1.

 Section 1209 of the Business and Professions Code is amended to read:

1209.

 (a) As used in this chapter, “laboratory director” means any person who is any of the following:

(1) A duly licensed physician and surgeon.

(2) Only for purposes of a clinical laboratory test or examination classified as waived, except as provided in paragraph (G), is any of the following:

(A) A duly licensed clinical laboratory scientist.

(B) A duly licensed limited clinical laboratory scientist.

(C) A duly licensed naturopathic doctor.

(D) A duly licensed optometrist serving as the director of a laboratory that only performs clinical laboratory tests authorized in clause (ii) of subparagraph (E) of paragraph (5) of subdivision (a) of Section 3041.

(E) A duly licensed dentist serving as the director of a laboratory that performs only clinical laboratory tests authorized within the scope of practice of dentistry as delineated under Section 1625.

(F) A pharmacist-in-charge of a pharmacy serving as the director of a laboratory that only performs tests waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a), as authorized by the Pharmacy Law (Chapter 9 (commencing with Section 4000)).

(G) A certified nurse-midwife serving as the director of a laboratory that only performs clinical laboratory tests classified as waived or provider-performed microscopy authorized within the scope of the certificate to practice nurse-midwifery as specified in Section 2746.5.

(3) Licensed to direct a clinical laboratory under this chapter.

(b) (1) A person defined in paragraph (1) or (3) of subdivision (a) who is identified as the CLIA laboratory director of a laboratory that performs clinical laboratory tests classified as moderate or high complexity shall also meet the laboratory director qualifications under CLIA for the type and complexity of tests being offered by the laboratory.

(2) As used in this subdivision, “CLIA laboratory director” means the person identified as the laboratory director on the CLIA certificate issued to the laboratory by the federal Centers for Medicare and Medicaid Services (CMS).

(c) The laboratory director, if qualified under CLIA, may perform the duties of the technical consultant, technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to persons qualified under CLIA. If the laboratory director reapportions performance of those responsibilities or duties, they shall remain responsible for ensuring that all those duties and responsibilities are properly performed.

(d) (1) The laboratory director is responsible for the overall operation and administration of the clinical laboratory, including administering the technical and scientific operation of a clinical laboratory, the selection and supervision of procedures, the reporting of results, and active participation in its operations to the extent necessary to ensure compliance with this act and CLIA. They shall be responsible for the proper performance of all laboratory work of all subordinates and shall employ a sufficient number of laboratory personnel with the appropriate education and either experience or training to provide appropriate consultation, properly supervise and accurately perform tests, and report test results in accordance with the personnel qualifications, duties, and responsibilities described in CLIA and this chapter.

(2) Where a point-of-care laboratory testing device is utilized and provides results for more than one analyte, the testing personnel may perform and report the results of all tests ordered for each analyte for which they have been found by the laboratory director to be competent to perform and report.

(e) As part of the overall operation and administration, the laboratory director of a registered laboratory shall document the adequacy of the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory test procedures and examinations. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for personnel, in addition to any CLIA requirements relative to the education or training of personnel.

(f) As part of the overall operation and administration, the laboratory director of a licensed laboratory shall do all of the following:

(1) Ensure that all personnel, prior to testing biological specimens, have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. In determining the adequacy of qualifications, the laboratory director shall comply with any regulations adopted by the department that specify the minimum qualifications for, and the type of procedures that may be performed by, personnel in addition to any CLIA requirements relative to the education or training of personnel. Any regulations adopted pursuant to this section that specify the type of procedure that may be performed by testing personnel shall be based on the skills, knowledge, and tasks required to perform the type of procedure in question.

(2) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to ensure that they are competent and maintain their competency to process biological specimens, perform test procedures, and report test results promptly and proficiently, and, whenever necessary, identify needs for remedial training or continuing education to improve skills.

(3) Specify in writing the responsibilities and duties of each individual engaged in the performance of the preanalytic, analytic, and postanalytic phases of clinical laboratory tests or examinations, including which clinical laboratory tests or examinations the individual is authorized to perform, whether supervision is required for the individual to perform specimen processing, test performance, or results reporting, and whether consultant, supervisor, or director review is required prior to the individual reporting patient test results.

(g) The competency and performance of staff of a licensed laboratory shall be evaluated and documented by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA depending on the type and complexity of tests being offered by the laboratory.

(1) The procedures for evaluating the competency of the staff shall include, but are not limited to, all of the following:

(A) Direct observations of routine patient test performance, including patient preparation, if applicable, and specimen handling, processing, and testing.

(B) Monitoring the recording and reporting of test results.

(C) Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records.

(D) Direct observation of performance of instrument maintenance and function checks.

(E) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples, or external proficiency testing samples.

(F) Assessment of problem solving skills.

(2) Evaluation and documentation of staff competency and performance shall occur at least semiannually during the first year an individual tests biological specimens. Thereafter, evaluations shall be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual’s performance shall be reevaluated to include the use of the new test methodology or instrumentation.

(h) The laboratory director of each clinical laboratory of an acute care hospital shall be a physician and surgeon who is a qualified pathologist, except as follows:

(1) If a qualified pathologist is not available, a physician and surgeon or a clinical laboratory bioanalyst qualified as a laboratory director under subdivision (a) may direct the laboratory. However, a qualified pathologist shall be available for consultation at suitable intervals to ensure high-quality service.

(2) If there are two or more clinical laboratories of an acute care hospital, those additional clinical laboratories that are limited to the performance of blood gas analysis, blood electrolyte analysis, or both, may be directed by a physician and surgeon qualified as a laboratory director under subdivision (a), irrespective of whether a pathologist is available.

As used in this subdivision, a qualified pathologist is a physician and surgeon certified or eligible for certification in clinical or anatomical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

(i) Subdivision (h) does not apply to any director of a clinical laboratory of an acute care hospital acting in that capacity on or before January 1, 1988.

(j) A laboratory director may serve as the director of up to the maximum number of laboratories stipulated by CLIA, as defined under Section 1202.5.

SEC. 4.SEC. 2.

 Section 2746.5 of the Business and Professions Code is amended to read:

2746.5.

 (a) The certificate to practice nurse-midwifery authorizes the holder to attend cases of low-risk pregnancy and childbirth and to provide prenatal care, intrapartum care, postpartum care, including immediate care for the newborn, interconception care, family planning care, and care for common gynecologic conditions, consistent with the Core Competencies for Basic Midwifery Practice adopted by the American College of Nurse-Midwives, or its successor national professional organization, as approved by the board. For purposes of this subdivision, “low-risk pregnancy” means a pregnancy in which all of the following conditions are met:

(1) There is a single fetus.

(2) There is a cephalic presentation at onset of labor.

(3) The gestational age of the fetus is greater than or equal to 37 weeks and zero days and less than or equal to 42 weeks and zero days at the time of delivery.

(4) Labor is spontaneous or induced.

(5) The patient has no preexisting disease or condition, whether arising out of the pregnancy or otherwise, that adversely affects the pregnancy and that the certified nurse-midwife is not qualified to independently address consistent with this section.

(b) (1) The certificate to practice nurse-midwifery authorizes the holder, pursuant to policies and protocols that are mutually agreed upon with a physician and surgeon, that delineate the parameters for consultation, collaboration, referral, and transfer of a patient’s care, and are signed by both the certified nurse-midwife and a physician and surgeon, to do either of the following:

(A) Provide a patient with care that falls outside the scope of services specified in subdivision (a).

(B) Provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium.

(2) If a physician and surgeon assumes care of the patient, the certified nurse-midwife may continue to attend the birth of the newborn and participate in physical care, counseling, guidance, teaching, and support, as indicated by the mutually agreed-upon policies and protocols signed by both the certified nurse-midwife and a physician and surgeon.

(3) After a certified nurse-midwife refers a patient to a physician and surgeon, the certified nurse-midwife may continue care of the patient during a reasonable interval between the referral and the initial appointment with the physician and surgeon.

(c) (1) If a nurse-midwife does not have in place mutually agreed-upon policies and protocols that delineate the parameters for consultation, collaboration, referral, and transfer of a patient’s care, signed by both the certified nurse-midwife and a physician and surgeon pursuant to paragraph (1) of subdivision (b), the patient shall be transferred to the care of a physician and surgeon to do either or both of the following:

(A) Provide a patient with care that falls outside the scope of services specified in subdivision (a).

(B) Provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium.

(2) After the certified nurse-midwife initiates the process of transfer pursuant to paragraph (1), for a patient who otherwise meets the definition of a low-risk pregnancy but no longer meets the criteria specified in paragraph (3) of subdivision (a) because the gestational age of the fetus is greater than 42 weeks and zero days, if there is inadequate time to effect safe transfer to a hospital prior to delivery or transfer may pose a threat to the health and safety of the patient or the unborn child, the certified nurse-midwife may continue care of the patient consistent with the transfer plan described in subdivision (a) of Section 2746.54.

(3) A patient who has been transferred from the care of a certified nurse-midwife to that of a physician and surgeon may return to the care of the certified nurse-midwife after the physician and surgeon has determined that the condition or circumstance that required, or would require, the transfer from the care of the nurse-midwife pursuant to paragraph (1) is resolved.

(d) The certificate to practice nurse-midwifery authorizes the holder to attend pregnancy and childbirth in an out-of-hospital setting if consistent with subdivisions (a), (b), and (c).

(e) This section shall not be interpreted to deny a patient’s right to self-determination or informed decisionmaking with regard to choice of provider or birth setting.

(f) The certificate to practice nurse-midwifery does not authorize the holder of the certificate to assist childbirth by vacuum or forceps extraction, or to perform any external cephalic version.

(g) A certified nurse-midwife shall document all consultations, referrals, and transfers in the patient record.

(h) (1) A certified nurse-midwife shall refer all emergencies to a physician and surgeon immediately.

(2) A certified nurse-midwife may provide emergency care until the assistance of a physician and surgeon is obtained.

(i) This chapter does not authorize a nurse-midwife to practice medicine or surgery.

(j) This section shall not be construed to require a physician and surgeon to sign protocols and procedures for a nurse-midwife or to permit any action that violates Section 2052 or 2400.

(k) This section shall not be construed to require a nurse-midwife to have mutually agreed-upon, signed policies and protocols for the provision of services described in subdivision (a).

(l) Notwithstanding any other law, subject to the discretion of a hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, and the medical staff bylaws of that facility, a hospital may grant privileges to a certified nurse-midwife, allowing them to admit and discharge patients upon their own authority, within their scope of practice, as delineated in this section, and in accordance with the bylaws of that facility.

SEC. 5.SEC. 3.

 Section 2746.51 of the Business and Professions Code is amended to read:

2746.51.

 (a) Neither this chapter nor any other law shall be construed to prohibit a certified nurse-midwife from furnishing or ordering drugs or devices, including controlled substances classified in Schedule II, III, IV, or V under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code), when the drugs or devices are furnished or ordered incidentally to the provision of the care and services described in Section 2746.5, consistent with the certified nurse-midwife’s educational preparation or for which clinical competency has been established and maintained, in any location in which the nurse-midwife provides care and services, including care rendered in an out-of-hospital setting pursuant to subdivision (d) of Section 2746.5.

(1) The furnishing or ordering of drugs or devices by a certified nurse-midwife for services that do not fall within the scope of services specified in subdivision (a) of Section 2746.5 shall be furnished in accordance with, and specified in, the policies and protocols mutually agreed upon pursuant to paragraph (1) of subdivision (b) of Section 2746.5, which shall specify all of the following:

(A) Which certified nurse-midwife may furnish or order drugs or devices.

(B) Which drugs or devices may be furnished or ordered and under what circumstances.

(C) The method of periodic review of the certified nurse-midwife’s competence, including peer review, and review of the provisions of the standardized procedure.

(2) The furnishing or ordering of a Schedule II or III controlled substance by a certified nurse-midwife for services that do not fall within the scope of services specified in subdivision (a) of Section 2746.5 shall be furnished or ordered in accordance with a patient-specific protocol contained within the policies and protocols mutually agreed upon pursuant to paragraph (1) of subdivision (b) of Section 2746.5 that identifies the patient conditions for which the certified nurse-midwife is authorized to furnish or order the Schedule II or III controlled substance.

(b) (1) The furnishing or ordering of drugs or devices by a certified nurse-midwife is conditional on the issuance by the board of a number to the applicant who has successfully completed the requirements of paragraph (2). The board may issue a furnishing number upon initial application and, if approved by the board, the applicant shall not be required to make a separate application. The number shall be included on all transmittals of orders for drugs or devices by the certified nurse-midwife. The board shall maintain a list of the certified nurse-midwives that it has certified pursuant to this paragraph and the number it has issued to each one. The board shall make the list available to the California State Board of Pharmacy upon its request. Every certified nurse-midwife who is authorized pursuant to this section to furnish or issue a drug order for a controlled substance shall register with the United States Drug Enforcement Administration and the Controlled Substance Utilization Review and Enforcement System (CURES) pursuant to Section 11165.1 of the Health and Safety Code.

(2) The board has certified in accordance with paragraph (1) that the certified nurse-midwife has satisfactorily completed a course in pharmacology covering the drugs or devices to be furnished or ordered under this section, including the risks of addiction and neonatal abstinence syndrome associated with the use of opioids. The board shall establish the requirements for satisfactory completion of this paragraph.

(3) Certified nurse-midwives who are certified by the board and hold an active furnishing number and who are registered with the United States Drug Enforcement Administration shall provide documentation of continuing education specific to the use of Schedule II controlled substances in settings other than a hospital based on standards developed by the board.

(c) Furnishing of drugs or devices by a certified nurse-midwife means the act of making a pharmaceutical agent or agents available to the patient through the ordering, administering, or dispensing of those pharmaceutical agents in accordance with this section or transmitting an order of a physician or surgeon.

(d) “Drug order” or “order” for purposes of this section means an order for medication or for a drug or device that is dispensed to or for an ultimate user, issued by a certified nurse-midwife as an individual practitioner, within the meaning of Section 1306.03 of Title 21 of the Code of Federal Regulations. Notwithstanding any other provision of law, (1) a drug order issued pursuant to this section shall be treated in the same manner as a prescription of the supervising physician; (2) all references to “prescription” in this code and the Health and Safety Code shall include drug orders issued by certified nurse-midwives; and (3) the signature of a certified nurse-midwife on a drug order issued in accordance with this section shall be deemed to be the signature of a prescriber for purposes of this code and the Health and Safety Code.

(e) Notwithstanding any other law, a certified nurse-midwife may directly procure supplies and devices, obtain and administer diagnostic tests, directly obtain and administer nonscheduled drugs, and dispense drugs pursuant to Section 4170, consistent with the provision of services that fall within the scope of services specified in subdivision (a) of Section 2746.5, order laboratory and diagnostic testing, and receive reports that are necessary to their practice as a certified nurse-midwife within their scope of practice, consistent with Section 2746.5.

SEC. 6.SEC. 4.

 Section 4170 of the Business and Professions Code is amended to read:

4170.

 (a) A prescriber shall not dispense drugs or dangerous devices to patients in the prescriber’s office or place of practice unless all of the following conditions are met:

(1) The dangerous drugs or dangerous devices are dispensed to the prescriber’s own patient, and the drugs or dangerous devices are not furnished by a nurse or physician attendant.

(2) The dangerous drugs or dangerous devices are necessary in the treatment of the condition for which the prescriber is attending the patient.

(3) The prescriber does not keep a pharmacy, open shop, or drugstore, advertised or otherwise, for the retailing of dangerous drugs, dangerous devices, or poisons.

(4) The prescriber fulfills all of the labeling requirements imposed upon pharmacists by Section 4076, all of the recordkeeping requirements of this chapter, and all of the packaging requirements of good pharmaceutical practice, including the use of childproof containers.

(5) The prescriber does not use a dispensing device unless the prescriber personally owns the device and the contents of the device, and personally dispenses the dangerous drugs or dangerous devices to the patient packaged, labeled, and recorded in accordance with paragraph (4).

(6) The prescriber, before dispensing, offers to give a written prescription to the patient that the patient may elect to have filled by the prescriber or by any pharmacy.

(7) The prescriber provides the patient with written disclosure that the patient has a choice between obtaining the prescription from the dispensing prescriber or obtaining the prescription at a pharmacy of the patient’s choice.

(b) A certified nurse-midwife who functions pursuant to a mutually agreed-upon policy or protocol described in Section 2746.5, a nurse practitioner who functions pursuant to a standardized procedure described in Section 2836.1, or protocol, a physician assistant who functions pursuant to Section 3502.1, or a naturopathic doctor who functions pursuant to Section 3640.5, may hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer as defined in this chapter, or a pharmacist.

(c) The Medical Board of California, the California State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Podiatric Medical Board of California, the Osteopathic Medical Board of California, the Board of Registered Nursing, the Veterinary Medical Board, and the Physician Assistant Board shall have authority with the California State Board of Pharmacy to ensure compliance with this section, and those boards are specifically charged with the enforcement of this chapter with respect to their respective licensees.

(d) “Prescriber,” as used in this section, means a person who holds a physician’s and surgeon’s certificate, a license to practice optometry, a license to practice naturopathic medicine, a license to practice dentistry, a license to practice veterinary medicine, a certificate to practice podiatry, a certificate to practice as a nurse practitioner practicing pursuant to Section 2837.103 or 2837.104, or a certificate to practice as a nurse-midwife, and who is duly registered by the Medical Board of California, the Osteopathic Medical Board of California, the California State Board of Optometry, the Bureau of Naturopathic Medicine, the Dental Board of California, the Veterinary Medical Board, the Podiatric Medical Board of California, or the Board of Registered Nursing.

SEC. 7.SEC. 5.

 Section 2708 of the Unemployment Insurance Code is amended to read:

2708.

 (a) (1) In accordance with the director’s authorized regulations, and except as provided in subdivision (c) and Sections 2708.1 and 2709, a claimant shall establish medical eligibility for each uninterrupted period of disability by filing a first claim for disability benefits supported by the certificate of a treating physician or practitioner that establishes the sickness, injury, or pregnancy of the employee, or the condition of the family member that warrants the care of the employee. For subsequent periods of uninterrupted disability after the period covered by the initial certificate or any preceding continued claim, a claimant shall file a continued claim for those benefits supported by the certificate of a treating physician or practitioner. A certificate filed to establish medical eligibility for the employee’s own sickness, injury, or pregnancy shall contain a diagnosis and diagnostic code prescribed in the International Classification of Diseases, or, if no diagnosis has yet been obtained, a detailed statement of symptoms.

(2) A certificate filed to establish medical eligibility of the employee’s own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physician’s or practitioner’s knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physician’s or practitioner’s conclusion as to the claimant’s disability, and a statement of the physician’s or practitioner’s opinion as to the expected duration of the disability.

(b) An employee shall be required to file a certificate to establish eligibility when taking leave to care for a family member with a serious health condition. The certificate shall be developed by the department. In order to establish medical eligibility of the serious health condition of the family member that warrants the care of the employee, the information shall be within the physician’s or practitioner’s knowledge and shall be based on a physical examination and documented medical history of the family member and shall contain all of the following:

(1) A diagnosis and diagnostic code prescribed in the International Classification of Diseases, or, if no diagnosis has yet been obtained, a detailed statement of symptoms.

(2) The date, if known, on which the condition commenced.

(3) The probable duration of the condition.

(4) An estimate of the amount of time that the physician or practitioner believes the employee needs to care for the child, parent, grandparent, grandchild, sibling, spouse, or domestic partner.

(5) (A) A statement that the serious health condition warrants the participation of the employee to provide care for their child, parent, grandparent, grandchild, sibling, spouse, or domestic partner.

(B) “Warrants the participation of the employee” includes, but is not limited to, providing psychological comfort, and arranging “third party” care for the child, parent, grandparent, grandchild, sibling, spouse, or domestic partner, as well as directly providing, or participating in, the medical care.

(c) The department shall develop a certification form for bonding that is separate and distinct from the certificate required in subdivision (a) for an employee taking leave to bond with a minor child within the first year of the child’s birth or placement in connection with foster care or adoption.

(d) The first and any continuing claim of an individual who obtains care and treatment outside this state shall be supported by a certificate of a treating physician or practitioner duly licensed or certified by the state or foreign country in which the claimant is receiving the care and treatment. If a physician or practitioner licensed by and practicing in a foreign country is under investigation by the department for filing false claims and the department does not have legal remedies to conduct a criminal investigation or prosecution in that country, the department may suspend the processing of all further certifications until the physician or practitioner fully cooperates, and continues to cooperate, with the investigation. A physician or practitioner licensed by, and practicing in, a foreign country who has been convicted of filing false claims with the department may not file a certificate in support of a claim for disability benefits for a period of five years.

(e) For purposes of this part:

(1) “Physician” has the same meaning as defined in Section 3209.3 of the Labor Code.

(2) (A) “Practitioner” means a person duly licensed or certified in California acting within the scope of their license or certification who is a dentist, podiatrist, or a nurse practitioner, and in the case of a nurse practitioner, after performance of a physical examination by a nurse practitioner and collaboration with a physician and surgeon, or as to low-risk pregnancy and childbirth or postpartum conditions consistent with the scope of their professional licensure, a midwife or nurse-midwife, or nurse practitioner.

(B) “Practitioner” also means a physician assistant who has performed a physical examination under the supervision of a physician and surgeon. Funds appropriated to cover the costs required to implement this subparagraph shall come from the Unemployment Compensation Disability Fund. This subparagraph shall be implemented on or before January 1, 2017.

(f) For a claimant who is hospitalized in or under the authority of a county hospital in this state, a certificate of initial and continuing medical disability, if any, shall satisfy the requirements of this section if the disability is shown by the claimant’s hospital chart, and the certificate is signed by the hospital’s registrar. For a claimant hospitalized in or under the care of a medical facility of the United States government, a certificate of initial and continuing medical disability, if any, shall satisfy the requirements of this section if the disability is shown by the claimant’s hospital chart, and the certificate is signed by a medical officer of the facility duly authorized to do so.

(g) Nothing in this section shall be construed to preclude the department from requesting additional medical evidence to supplement the first or any continued claim if the additional evidence can be procured without additional cost to the claimant. The department may require that the additional evidence include any or all of the following:

(1) Identification of diagnoses.

(2) Identification of symptoms.

(3) A statement setting forth the facts of the claimant’s disability. The statement shall be completed by any of the following individuals:

(A) The physician or practitioner treating the claimant.

(B) The registrar, authorized medical officer, or other duly authorized official of the hospital or health facility treating the claimant.

(C) An examining physician or other representative of the department.

(h) This section shall become operative on July 1, 2014.