SB 667: Healing arts: pregnancy and childbirth.
- Session Year: 2023-2024
- House: Senate
- Latest Version Date: 2023-10-08
Current Status:
Passed
(2023-10-08: Chaptered by Secretary of State. Chapter 497, Statutes of 2023.)
Introduced
In Committee
First Chamber
In Committee
Second Chamber
Enacted
What does this bill do?
The bill expands the medical duties of certified nurse‑midwives in California. They may treat common gynecologic conditions without extra physician protocols, provide labor care after a prior cesarean or uterine surgery, and—under mutually agreed policies with a physician—furnish or order certain regulated drugs (Schedules II and III) and dispense drugs for pregnancy and gynecologic care. It also lets hospitals grant midwives admitting and discharge privileges, recognizes nurse‑midwives as lab directors for waived CLIA or provider‑performed microscopy tests, and allows midwives or nurse practitioners to certify pregnancy‑related disability for unemployment claims within their license.
The summary is provided by generative AI which can make mistakes. For original language, please view the details in the table below.
(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, to provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium, or to furnish or order a Schedule II or III controlled substance, as specified. 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 general acute care hospital, as defined, or a special hospital specified as a maternity 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 organized medical staff bylaws of that facility and within the nurse-midwifes 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-midwifes 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 and patient-specific 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.
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 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 authorized within the scope of the nurse-midwifes 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 pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure, a midwife, nurse-midwife, or nurse practitioner.
(4)This bill would incorporate additional changes to Section 2746.5 of the Business and Professions Code proposed by SB 345 to be operative only if this bill and SB 345 are enacted and this bill is enacted last.
(5)This bill would incorporate additional changes to Section 2708 of the Unemployment Insurance Code proposed by AB 575 to be operative only if this bill and AB 575 are enacted and this bill is enacted last.
(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, to provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium, or to furnish or order a Schedule II or III controlled substance, as specified. 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 general acute care hospital, as defined, or a special hospital specified as a maternity 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 organized medical staff bylaws of that facility and within the nurse-midwifes 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-midwifes 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 and patient-specific 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.
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 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 authorized within the scope of the nurse-midwifes 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 pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure, a midwife, nurse-midwife, or nurse practitioner.
(4)This bill would incorporate additional changes to Section 2746.5 of the Business and Professions Code proposed by SB 345 to be operative only if this bill and SB 345 are enacted and this bill is enacted last.
(5)This bill would incorporate additional changes to Section 2708 of the Unemployment Insurance Code proposed by AB 575 to be operative only if this bill and AB 575 are enacted and this bill is enacted last.
(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, to provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium, or to furnish or order a Schedule II or III controlled substance, as specified. 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 general acute care hospital, as defined, or a special hospital specified as a maternity 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 organized medical staff bylaws of that facility and within the nurse-midwifes 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-midwifes 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 and patient-specific 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.
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 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 authorized within the scope of the nurse-midwifes 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 pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure, a midwife, nurse-midwife, or nurse practitioner.
(4)This bill would incorporate additional changes to Section 2746.5 of the Business and Professions Code proposed by SB 345 to be operative only if this bill and SB 345 are enacted and this bill is enacted last.
(5)This bill would incorporate additional changes to Section 2708 of the Unemployment Insurance Code proposed by AB 575 to be operative only if this bill and AB 575 are enacted and this bill is enacted last.
(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 services, to provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium. myometrium, or to furnish or order a Schedule II or III controlled substance, as specified. 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 general acute care hospital, as defined, or a special hospital specified as a maternity 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 organized medical staff bylaws of that facility and within the nurse-midwifes 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-midwifes 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. protocols and patient-specific 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 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 authorized within the scope of the nurse-midwifes 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 pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure, a midwife, nurse-midwife, or nurse practitioner.
(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-midwifes 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-midwifes 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 providers license, if specified requirements are satisfied. The bill would make conforming changes. nurse-midwifes 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.
(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 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. Existing law authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum, as specified.
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 certified nurse-midwife who holds privileges in a general acute care 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-midwifes 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-midwifes 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 that are not dangerous, as defined, when attending cases of low-risk pregnancy and childbirth or providing prenatal care, intrapartum care, postpartum care, or care for common gynecologic conditions, as specified. 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.
This bill would, notwithstanding that prohibition, authorize an alternative birth center or primary care clinic, as defined, to perform testing and examinations classified as waived or a provider-performed microscopy consistent with services within the scope of the providers license, if specified requirements are satisfied. The bill would make conforming changes.
(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.
(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. Existing law authorizes a certified nurse-midwife to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum, as specified.
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 certified nurse-midwife who holds privileges in a general acute care hospital, as defined, to admit and discharge patients upon their own authority if in accordance with the bylaws of that facility and within the nurse-midwifes 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-midwifes 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 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.
This bill would additionally authorize a certified nurse-midwife to dispense drugs that are not dangerous, as defined, when attending cases of low-risk pregnancy and childbirth or providing prenatal care, intrapartum care, postpartum care, or care for common gynecologic conditions, as specified.
(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.
This bill would, notwithstanding that prohibition, authorize an alternative birth center or primary care clinic, as defined, to perform testing and examinations classified as waived or a provider-performed microscopy consistent with services within the scope of the providers license, if specified requirements are satisfied. The bill would make conforming changes.
(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 individuals 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. 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 patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon, to do any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
SEC. 2.5.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, and 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 by a physician and surgeon, that delineate the parameters for consultation, collaboration, referral, and transfer of a patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon, to do any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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 fetus, 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
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 all of the following apply:
(1)The drugs or devices are furnished or ordered incidentally to the provision of any of the following:
(A)The care and services described in Section 2746.5.
(B)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(C)Care rendered in an out-of-hospital setting pursuant to subdivision (d) of Section 2746.5.
(2)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-midwifes competence, including peer review, and review of the provisions of the standardized procedure.
(3)If Schedule II or III controlled substances, as defined in Sections 11055 and 11056 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife for any condition, including, but not limited to, Schedule II or III controlled substances for services that fall within the scope of services specified in subdivision (a) of Section 2746.5, the controlled substances shall be furnished or ordered in accordance with policies and protocols mutually agreed upon pursuant to paragraph (1) of subdivision (b) of Section 2746.5. For Schedule II controlled substance protocols, the provision for furnishing the Schedule II controlled substance shall address the diagnosis of the illness, injury, or condition for which the Schedule II controlled substance is to be furnished.
(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. Use of the term furnishing in this section shall include the following:
(1)The ordering of a nonscheduled drug or device for services that fall within the scope of services specified in subdivision (a) of Section 2746.5.
(2)The ordering of a nonscheduled drug or device for services that fall outside the scope of services specified in subdivision (a) of Section 2746.5 in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(3)The ordering of a Schedule IV or V drug for any condition, including, but not limited to, for care that falls within the scope of services specified in subdivision (a) of Section 2746.5.
(4)The ordering of a Schedule II or III drug in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(5)Transmitting an order of a physician and 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. 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 prescribers office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers 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 patients 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 California Board 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 physicians and surgeons 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 California Board 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. 5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 childs 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 pregnancy, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
SEC. 5.5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 one year of the childs birth, placement of the child in connection with foster care or adoption, or an individuals assumption of responsibilities for the child in loco parentis.
(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 pregnancy, 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.
(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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants hospital chart, and the certificate is signed by a medical officer of the facility duly authorized to do so.
(g)This section does not 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 claimants 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)The amendments made to subdivision (c) by the act adding this subdivision shall become operative on February 1, 2025.
SEC. 6.Section 2.5 of this bill incorporates amendments to Section 2746.5 of the Business and Professions Code proposed by both this bill and Senate Bill 345. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2024, (2) each bill amends Section 2746.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 345, in which case Section 2.5 of this bill shall not become operative.
SEC. 7.Section 5.5 of this bill incorporates amendments to Section 2708 of the Unemployment Insurance Code proposed by both this bill and Assembly Bill 575. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2024, (2) each bill amends Section 2708 of the Unemployment Insurance Code, and (3) this bill is enacted after Assembly Bill 575, in which case Section 5.5 of this bill shall not become operative.
(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 individuals 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. 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 patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon, to do any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
SEC. 2.5.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, and 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 by a physician and surgeon, that delineate the parameters for consultation, collaboration, referral, and transfer of a patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon, to do any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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 fetus, 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
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 all of the following apply:
(1)The drugs or devices are furnished or ordered incidentally to the provision of any of the following:
(A)The care and services described in Section 2746.5.
(B)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(C)Care rendered in an out-of-hospital setting pursuant to subdivision (d) of Section 2746.5.
(2)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-midwifes competence, including peer review, and review of the provisions of the standardized procedure.
(3)If Schedule II or III controlled substances, as defined in Sections 11055 and 11056 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife for any condition, including, but not limited to, Schedule II or III controlled substances for services that fall within the scope of services specified in subdivision (a) of Section 2746.5, the controlled substances shall be furnished or ordered in accordance with policies and protocols mutually agreed upon pursuant to paragraph (1) of subdivision (b) of Section 2746.5. For Schedule II controlled substance protocols, the provision for furnishing the Schedule II controlled substance shall address the diagnosis of the illness, injury, or condition for which the Schedule II controlled substance is to be furnished.
(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. Use of the term furnishing in this section shall include the following:
(1)The ordering of a nonscheduled drug or device for services that fall within the scope of services specified in subdivision (a) of Section 2746.5.
(2)The ordering of a nonscheduled drug or device for services that fall outside the scope of services specified in subdivision (a) of Section 2746.5 in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(3)The ordering of a Schedule IV or V drug for any condition, including, but not limited to, for care that falls within the scope of services specified in subdivision (a) of Section 2746.5.
(4)The ordering of a Schedule II or III drug in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(5)Transmitting an order of a physician and 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. 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 prescribers office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers 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 patients 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 California Board 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 physicians and surgeons 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 California Board 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. 5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 childs 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 pregnancy, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
SEC. 5.5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 one year of the childs birth, placement of the child in connection with foster care or adoption, or an individuals assumption of responsibilities for the child in loco parentis.
(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 pregnancy, 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.
(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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants hospital chart, and the certificate is signed by a medical officer of the facility duly authorized to do so.
(g)This section does not 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 claimants 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)The amendments made to subdivision (c) by the act adding this subdivision shall become operative on February 1, 2025.
SEC. 6.Section 2.5 of this bill incorporates amendments to Section 2746.5 of the Business and Professions Code proposed by both this bill and Senate Bill 345. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2024, (2) each bill amends Section 2746.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 345, in which case Section 2.5 of this bill shall not become operative.
SEC. 7.Section 5.5 of this bill incorporates amendments to Section 2708 of the Unemployment Insurance Code proposed by both this bill and Assembly Bill 575. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2024, (2) each bill amends Section 2708 of the Unemployment Insurance Code, and (3) this bill is enacted after Assembly Bill 575, in which case Section 5.5 of this bill shall not become operative.
(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 individuals 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. 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 patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon, to do any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
SEC. 2.5.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, intrapartum, prenatal care, intrapartum care, and postpartum care, including immediate care for the newborn, interconception care, family planning care, and immediate care for the newborn, 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 to practice with a physician and surgeon under mutually agreed-upon policies and protocols holder, pursuant to policies and protocols that are mutually agreed upon by a physician and surgeon, that delineate the parameters for consultation, collaboration, referral, and transfer of a patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon surgeon, to do either any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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, fetus, 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
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 all of the following apply:
(1)The drugs or devices are furnished or ordered incidentally to the provision of any of the following:
(A)The care and services described in Section 2746.5.
(B)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(C)Care rendered in an out-of-hospital setting pursuant to subdivision (d) of Section 2746.5.
(2)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-midwifes competence, including peer review, and review of the provisions of the standardized procedure.
(3)If Schedule II or III controlled substances, as defined in Sections 11055 and 11056 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife for any condition, including, but not limited to, Schedule II or III controlled substances for services that fall within the scope of services specified in subdivision (a) of Section 2746.5, the controlled substances shall be furnished or ordered in accordance with policies and protocols mutually agreed upon pursuant to paragraph (1) of subdivision (b) of Section 2746.5. For Schedule II controlled substance protocols, the provision for furnishing the Schedule II controlled substance shall address the diagnosis of the illness, injury, or condition for which the Schedule II controlled substance is to be furnished.
(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. Use of the term furnishing in this section shall include the following:
(1)The ordering of a nonscheduled drug or device for services that fall within the scope of services specified in subdivision (a) of Section 2746.5.
(2)The ordering of a nonscheduled drug or device for services that fall outside the scope of services specified in subdivision (a) of Section 2746.5 in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(3)The ordering of a Schedule IV or V drug for any condition, including, but not limited to, for care that falls within the scope of services specified in subdivision (a) of Section 2746.5.
(4)The ordering of a Schedule II or III drug in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(5)Transmitting an order of a physician and 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. 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 prescribers office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers 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 patients 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 California Board 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 physicians and surgeons 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 California Board 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. 5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 childs 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 pregnancy, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
SEC. 5.5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 his or her 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 one year of the childs birth or placement birth, placement of the child in connection with foster care or adoption. adoption, or an individuals assumption of responsibilities for the child in loco parentis.
(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 his or her 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 normal pregnancy or childbirth, pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure, a midwife or nurse midwife, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 This section does not 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 claimants 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.(h)The amendments made to subdivision (c) by the act adding this subdivision shall become operative on February 1, 2025.
SEC. 6.Section 2.5 of this bill incorporates amendments to Section 2746.5 of the Business and Professions Code proposed by both this bill and Senate Bill 345. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2024, (2) each bill amends Section 2746.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 345, in which case Section 2.5 of this bill shall not become operative.
SEC. 7.Section 5.5 of this bill incorporates amendments to Section 2708 of the Unemployment Insurance Code proposed by both this bill and Assembly Bill 575. That section of this bill shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2024, (2) each bill amends Section 2708 of the Unemployment Insurance Code, and (3) this bill is enacted after Assembly Bill 575, in which case Section 5.5 of this bill shall not become operative.
(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 individuals 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. 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 patients care, and that are signed by both the certified nurse-midwife and a physician and surgeon, to do either any 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.
(C)Furnish or order a Schedule II or III controlled substance, including for patients that fall within the scope of services specified in subdivision (a).
(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 patients 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 patients 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 general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, or a special hospital specified as a maternity hospital, as defined in subdivision (f) 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 organized medical staff bylaws of that facility.
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-midwifes 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. all of the following apply:
(1)The drugs or devices are furnished or ordered incidentally to the provision of any of the following:
(A)The care and services described in Section 2746.5.
(B)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.
(C)Care rendered in an out-of-hospital setting pursuant to subdivision (d) of Section 2746.5.
(1)(2)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-midwifes 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.(3)If Schedule II or III controlled substances, as defined in Sections 11055 and 11056 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife for any condition, including, but not limited to, Schedule II or III controlled substances for services that fall within the scope of services specified in subdivision (a) of Section 2746.5, the controlled substances shall be furnished or ordered in accordance with policies and protocols mutually agreed upon pursuant to paragraph (1) of subdivision (b) of Section 2746.5. For Schedule II controlled substance protocols, the provision for furnishing the Schedule II controlled substance shall address the diagnosis of the illness, injury, or condition for which the Schedule II controlled substance is to be furnished.
(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. patient. Use of the term furnishing in this section shall include the following:
(1)The ordering of a nonscheduled drug or device for services that fall within the scope of services specified in subdivision (a) of Section 2746.5.
(2)The ordering of a nonscheduled drug or device for services that fall outside the scope of services specified in subdivision (a) of Section 2746.5 in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(3)The ordering of a Schedule IV or V drug for any condition, including, but not limited to, for care that falls within the scope of services specified in subdivision (a) of Section 2746.5.
(4)The ordering of a Schedule II or III drug in accordance with mutually agreed upon policies and protocols pursuant to paragraph (1) of subdivision (b) of Section 2746.5.
(5)Transmitting an order of a physician and 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. 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 prescribers office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers 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 patients 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 California Board 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 physicians and surgeons 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 California Board 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. 5.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 childs 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 pregnancy, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
REVISIONS: HeadingLine 2.(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 individuals 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 patients 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 patients 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 patients 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-midwifes 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-midwifes 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 prescribers office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers 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 patients 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 physicians and surgeons 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 directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 childs 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
(a)Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Sections 1206.6, 1206.7, 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 1206.7, 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 patients 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 persons 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 persons 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 patients 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 patients 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 patients 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 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 patients 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, nurse-midwife, licensed nurse practitioner, or licensed physician assistant is an employee.
(4)A licensed dentist using the microscope during the patients 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 1206.7 is added to the Business and Professions Code, to read:1206.7.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 providers 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 laboratorys 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 patients 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 laboratorys 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 laboratorys 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 1206.7, 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 1206.7. 1206.8.
SEC. 4.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 performing or repairing an episiotomy and repairing first-degree or second-degree lacerations of the perineum, 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 to provide care specified in subparagraphs (A) and (B) holder, pursuant to policies and protocols that are mutually agreed upon with a physician and surgeon surgeon, that delineate the parameters for consultation, collaboration, referral, and transfer of a patients care care, and are signed by both the certified nurse-midwife and a physician and surgeon. surgeon, to do either of the following:
(A)Care Provide a patient with care that falls outside the scope of services specified in subdivision (a).
(B)Intrapartum 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 patients 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 patients 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, a certified nurse-midwife who holds privileges in a general acute care subject to the discretion of a hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, may 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.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 2746.5, consistent with the certified nurse-midwifes 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-midwifes 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 that are not dangerous, as defined in Section 4022, 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.Section 2746.52 of the Business and Professions Code is repealed.SEC. 6.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 prescribers office or place of practice unless all of the following conditions are met:
(1)The dangerous drugs or dangerous devices are dispensed to the prescribers 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 patients choice.
(8)(b)A certified nurse-midwife who functions pursuant to a standardized procedure mutually agreed-upon policy or protocol described in Section 2746.51, 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.
(b)(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.
(c)(d)Prescriber, as used in this section, means a person, person who holds a physicians and surgeons 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, or 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.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 childs 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, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
(a)Notwithstanding subdivision (b) of Section 1206 and except as otherwise provided in Sections 1206.6 1206.6, 1206.7, 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, 1206 and except as otherwise provided in Section 1206.7, 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 patients 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 persons 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 persons 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 patients 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 patients 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 patients 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 patients 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 patients 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 1206.7 is added to the Business and Professions Code, to read:1206.7.(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 providers 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 his or her 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 laboratorys 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 patients 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 laboratorys 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 laboratorys 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 1206.7, 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 1206.7.
SEC. 4.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, intrapartum, and prenatal care, intrapartum care, postpartum care, including performing or repairing an episiotomy and repairing first-degree or second-degree lacerations of the perineum, immediate care for the newborn, interconception care, family planning care, and immediate care for the newborn, 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 to practice with a physician and surgeon under mutually agreed-upon provide care specified in subparagraphs (A) and (B) 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 patients care, care and are signed by both the certified nurse-midwife and a physician and surgeon to do either of the following: surgeon.
(A)Provide a patient with care Care that falls outside the scope of services specified in subdivision (a).
(B)Provide intrapartum 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 patients 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 patients 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, a certified nurse-midwife who holds privileges in a general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code, may 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.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 all of the following apply:
(1)The when the drugs or devices are furnished or ordered incidentally to the provision of any of the following:
(A)The of the care and services described in Section 2746.5.
(B)Care rendered, consistent with the certified nurse-midwifes educational preparation or for which clinical competency has been established and maintained, to persons within a facility specified in subdivision (a), (b), (c), (d), (i), or (j) of Section 1206 of the Health and Safety Code, a clinic as specified in Section 1204 of the Health and Safety Code, a general acute care hospital as defined in subdivision (a) of Section 1250 of the Health and Safety Code, a licensed birth center as defined in Section 1204.3 of the Health and Safety Code, or a special hospital specified as a maternity hospital in subdivision (f) of Section 1250 of the Health and Safety Code.(C)Care Section 2746.5 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.
(2)(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, and Schedule IV or V controlled substances by a nurse-midwife for any condition, including, but not limited to, Schedule IV or V controlled substances for services that fall within the scope of services specified in subdivision (a) of Section 2746.5, are in accordance with the standardized procedures or protocols. For purposes of this section, standardized procedure means a document, including protocols, developed in collaboration with, and approved by, a physician and surgeon and the certified nurse-midwife. The standardized procedure covering the furnishing or ordering of drugs or devices shall specify all of the following: 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-midwifes competence, including peer review, and review of the provisions of the standardized procedure.(3)If Schedule II or III controlled substances, as defined in Sections 11055 and 11056 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife for any condition, including, but not limited to, Schedule II or III controlled substances for services that fall within the scope of services specified in subdivision (a) of Section 2746.5, the controlled substances shall be furnished or ordered in accordance with a patient-specific protocol approved by a physician and surgeon. For Schedule II controlled substance protocols, the provision for furnishing the Schedule II controlled substance shall address the diagnosis of the illness, injury, or condition for which the Schedule II controlled substance is to be furnished.(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)A copy of the standardized procedure or protocol relating to the furnishing or ordering of controlled substances by a certified nurse-midwife shall be provided upon request to any licensed pharmacist who is uncertain of the authority of the certified nurse-midwife to perform these functions. (4)(3)Certified nurse-midwives who are certified by the board and hold an active furnishing number, who are currently authorized through standardized procedures or protocols to furnish Schedule II controlled substances, 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)Drugs or devices furnished or ordered by a certified nurse-midwife may include Schedule II controlled substances under the California Uniform Controlled Substances Act (Division 10 (commencing with Section 11000) of the Health and Safety Code) under the following conditions:(1)The drugs and devices are furnished or ordered in accordance with requirements referenced in subdivisions (a) and (b).(2)When Schedule II controlled substances, as defined in Section 11055 of the Health and Safety Code, are furnished or ordered by a certified nurse-midwife, the controlled substances shall be furnished or ordered in accordance with a patient-specific protocol approved by a physician and surgeon.(d)(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. Use of the term furnishing in this section shall include the following: 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.
(1)The ordering of a nonscheduled drug or device for services that fall within the scope of services specified in subdivision (a) of Section 2746.5.(2)The ordering of a nonscheduled drug or device for services that fall outside the scope of services specified in subdivision (a) of Section 2746.5 in accordance with standardized procedures or protocols pursuant to paragraph (2) of subdivision (a).(3)The ordering of a Schedule IV or V drug for any condition, including, but not limited to, for care that falls within the scope of services specified in subdivision (a) of Section 2746.5, in accordance with standardized procedures or protocols pursuant to paragraph (2) of subdivision (a).(4)The ordering of a Schedule II or III drug in accordance with a patient-specific protocol approved by a physician and surgeon pursuant to paragraph (3) of subdivision (a).(5)Transmitting an order of a physician and surgeon.(e)(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.
(f)(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 drugs, and dispense drugs that are not dangerous, as defined in Section 4022, 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.Section 2746.52 of the Business and Professions Code is repealed.2746.52.(a)Notwithstanding Section 2746.5, the certificate to practice nurse-midwifery authorizes the holder to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum.(b)A certified nurse-midwife performing and repairing first-degree and second-degree lacerations of the perineum shall do both of the following:(1)Ensure that all complications are referred to a physician and surgeon immediately.(2)Ensure immediate care of patients who are in need of care beyond the scope of practice of the certified nurse-midwife, or emergency care for times when a physician and surgeon is not on the premises.SEC. 7.Section 2708 of the Unemployment Insurance Code is amended to read:2708.(a)(1)In accordance with the directors 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 employees 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 employees own sickness, injury, or pregnancy shall also contain a statement of medical facts, including secondary diagnoses when applicable, within the physicians or practitioners knowledge, based on a physical examination and a documented medical history of the claimant by the physician or practitioner, indicating the physicians or practitioners conclusion as to the claimants disability, and a statement of the physicians or practitioners 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 physicians or practitioners 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 his or her 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 childs 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 his or her 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 normal pregnancy or childbirth, 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 claimants hospital chart, and the certificate is signed by the hospitals 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 claimants 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 claimants 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.
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Date
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Status
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| Oct 8, 2023 | Chaptered by Secretary of State. Chapter 497, Statutes of 2023. |
| Oct 8, 2023 | Approved by the Governor. |
| Sep 20, 2023 | Enrolled and presented to the Governor at 4:30 p.m. |
| Sep 13, 2023 | Assembly amendments concurred in. (Ayes 39. Noes 0. Page 2742.) Ordered to engrossing and enrolling. |
| Sep 12, 2023 | In Senate. Concurrence in Assembly amendments pending. |
| Sep 12, 2023 | Read third time. Passed. (Ayes 79. Noes 0. Page 3251.) Ordered to the Senate. |
| Sep 7, 2023 | Read third time and amended. |
| Sep 7, 2023 | Ordered to third reading. |
| Sep 7, 2023 | Assembly Rule 69 suspended. (Ayes 62. Noes 15. Page 3010.) |
| Jul 13, 2023 | Ordered to third reading. |
| Jul 13, 2023 | From consent calendar on motion of Assembly Member Bryan. |
| Jul 13, 2023 | Read second time. Ordered to consent calendar. |
| Jul 12, 2023 | From committee: Do pass. Ordered to consent calendar. (Ayes 15. Noes 0.) (July 12). |
| Jun 27, 2023 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 18. Noes 0.) (June 27). Re-referred to Com. on APPR. |
| Jun 27, 2023 | Coauthors revised. |
| Jun 15, 2023 | Referred to Com. on B. & P. |
| Jun 1, 2023 | In Assembly. Read first time. Held at Desk. |
| May 31, 2023 | Read third time. Passed. (Ayes 40. Noes 0. Page 1403.) Ordered to the Assembly. |
| May 25, 2023 | Read second time. Ordered to third reading. |
| May 24, 2023 | Read third time and amended. |
| May 24, 2023 | Ordered to second reading. |
| May 2, 2023 | Read second time. Ordered to third reading. |
| May 1, 2023 | From committee: Be ordered to second reading pursuant to Senate Rule 28.8. |
| Apr 21, 2023 | Set for hearing May 1. |
| Apr 19, 2023 | Read second time and amended. Re-referred to Com. on APPR. |
| Apr 18, 2023 | From committee: Do pass as amended and re-refer to Com. on APPR. (Ayes 12. Noes 0. Page 747.) (April 17). |
| Apr 11, 2023 | From committee with author's amendments. Read second time and amended. Re-referred to Com. on B., P. & E. D. |
| Mar 6, 2023 | Set for hearing April 17. |
| Mar 1, 2023 | Referred to Com. on B., P. & E. D. |
| Feb 17, 2023 | From printer. May be acted upon on or after March 19. |
| Feb 16, 2023 | Introduced. Read first time. To Com. on RLS. for assignment. To print. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 13, 2023 | Unfinished Business SB667 Dodd et al. Concurrence | Senate Floor |
Passed |
|
| Sep 12, 2023 | SB 667 Dodd Senate Third Reading By Schiavo | Assembly Floor |
Passed |
|
| Jul 12, 2023 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Jun 27, 2023 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
|
| May 31, 2023 | Senate 3rd Reading SB667 Dodd | Senate Floor |
Passed |
|
| Apr 17, 2023 | Do pass as amended, but first amend, and re-refer to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| 2020 Mom | ** Support | |
| American Association of Birth Centers | ** Support | |
| American Association Of University Women - California | ** Support | |
| American College of OB/GYNs District 9 | * Against Unless Amend | Apr 17, 2023 |
| American Nurses Association/California | ** Support | |
| Best Start Birth Center | ** Support | |
| Black Women For Wellness Action Project | ** Support | |
| California Academy Of Family Physicians | * Against Unless Amend | Apr 17, 2023 |
| California Association for Nurse Practitioners | ** Support | |
| California Association of Nurse Anesthetists | ** Support | |
| California Medical Association | * Against Unless Amend | Apr 17, 2023 |
| California Nurse-Midwives Association | ** Support | |
| Citizens for Choice | ** Support | |
| Maternal and Child Health Access | ** Support | |
| NARAL Pro-Choice California | ** Support | |
| National Health Law Program | ** Support | |
| Purchaser Business Group on Health | ** Support | |
| San Francisco Black, Jewish and Unity Group | ** Support | |
| Sutter Davis Hospital | * Support | Apr 17, 2023 |
| Training In Early Abortion For Comprehensive Healthcare | ** Support | |
| Women'S Foundation California | ** Support | |
| Women's Health Specialists | ** Support |
SENATE RULES COMMITTEE Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB 667 |
UNFINISHED BUSINESS
Bill No: SB 667
Author: Dodd (D), et al.
Amended: 9/7/23
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 12-0, 4/17/23
AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Becker, Dodd, Eggman, Niello, Smallwood-Cuevas, Wahab, Wilk
NO VOTE RECORDED: Glazer
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SENATE FLOOR: 40-0, 5/31/23
AYES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk
ASSEMBLY FLOOR: 79-0, 9/12/23 - See last page for vote
SUBJECT: Healing arts: pregnancy and childbirth
SOURCE: Author
DIGEST:
This bill clarifies a certified nurse midwife’s (CNM) authority to treat and provide care for common gynecologic conditions; permits a CNM to admit or discharge a patient if a CNM has privileges at a general acute care hospital, as specified; clarifies that a CNM is a practitioner for purposes of certifying disability; and includes a CNMs as a laboratory director for purposes of performing specified laboratory tests, among other technical changes.
Assembly Amendments
resolve chaptering conflicts with various bills.
ANALYSIS:
Existing law:
- States that the certificate to practice nurse-midwifery authorizes the holder (CNM) 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. (Business and Professions Code (BPC) § 2745.6(b))
- Permits a CNM to furnish or order drugs or devices, including controlled substances classified in schedule II III IV or V, under the California Uniform Controlled Substances Act when the drugs or devices are furnished or ordered incidentally to the care and services are authorized in the certificate to practice midwifery and when the furnishing or ordering of drugs or devices by a CNM for services that do not fall within the certificate to practice midwifery are in accordance with standardized procedures or protocols, as defined; or a patient-specific protocol approved by a physician and surgeon, as specified. (BPC §2746.51(a))
- Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health (CDPH), with specified exceptions. (BPC § 1200-1327)
- Prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) (CLIA) unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director 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 specified personnel. (BPC § 1206.5(a))
- Defines a “practitioner” for purposes of a claimant establishing medical eligibility for filing a claim for disability benefits supported by the certificate of a treating physician or practitioner. (Unemployment Insurance Code § 2708(a)(1) and 2708(e)(2).
This bill:
- Adds common gynecologic conditions to the practice of midwifery by a CNM.
- Permits a CNM who holds privileges in a general acute care hospital, as defined, to admit and discharge patients upon their own authority, within their scope of practice and in accordance with the organized medical staff bylaws of that facility, as specified.
- Deletes the requirement that a copy of standardized procedure or protocol relating to the furnishing or ordering of controlled substances by a CNM be provided upon request to any licensed pharmacist who is uncertain of the CNM to perform these functions.
- Clarifies that a CNM may dispense drugs, which are defined in the pharmacy law as not dangerous, as specified.
- Adds a CNM to the definition of “prescriber” in the pharmacy law, as specified.
- Adds low-risk pregnancy and childbirth or postpartum conditions consistent with the scope of a CNM’s or midwife’s professional license to the definition of “practitioner” for purposes of obtaining medical eligibility for disability, as specified.
- Adds a CNM to the definition of laboratory director as long as the CNM only performs clinical laboratory tests classified as waived or provider-performed microscopy authorized within the scope of the certificate to practice midwifery, as specified.
- Makes other technical and clarifying changes.
Background
CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. These individuals are licensed by the Board of Registered Nursing (BRN), have acquired additional training in the field of obstetrics, and are certified by the American College of Nurse Midwives. In order to obtain a certificate to practice as a CNM, the applicant must provide proof to the BRN that they have either graduated from a BRN approved program in nurse-midwifery or satisfied equivalence standards as set forth in the BRN’s regulations (Title 16 California Code of Regulations § 1460).
The nurse-midwifery certificate authorizes the CNM to attend cases of low-risk pregnancy and childbirth, as well as immediate care for the newborn along with family planning and interconception care. CNMs may furnish or order drugs and devices in certain healthcare settings. If a CNM orders or furnishes a drug or device that would be outside of the standard of care authorized by the certificate to practice midwifery, the CNM may only do so if they have established mutually agreed upon protocols with a physician and surgeon. Additionally, in order to furnish drugs or devices, the CNM must obtain a furnishing number from the BRN, and register with the United States Drug Enforcement Administration and the Controlled Substance Utilization Review and Enforcement System.
Prior to 2020, CNMs were required to practice under the supervision of a physician and surgeon under standardized procedures and protocols. SB 1237 (Dodd, Chapter, Statutes of 2019) eliminated the requirement for a CNM to practice midwifery according to standardized procedures or protocols with a physician in an effort to allow CNMs to practice independently of physician supervision. That bill revised provisions defining the practice of midwifery, authorized a CNM to attend cases of childbirth outside of a define hospital setting; authorized a CNM to furnish or order drugs or devices in accordance with standardized protocols with a physician; required a CNM to provide specified disclosures to a patient; and, established new reporting and data collection requirements. SB 1237 did not change the scope of work that a CMN could perform, but permitted a CNM to perform their work without physician supervision.
This bill adds CNMs to the definition of “practitioner” under the unemployment insurance code to ensure that CNMs can establish eligibility for disability purposes related to low-risk pregnancy, childbirth and postpartum conditions. This bill also adds the care of “common gynecological conditions” to the list of services that a CNM is able to provide based on a certificate to practice midwifery. If a CNM were to provide care for a gynecological condition that falls outside that normal parameter, they would subject themselves to potential enforcement by the BRN. This bill updates the pharmacy law to include CNMs in the definition of “prescriber”, among other provisions.
A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements. At the federal level and in California, anyone may perform a waived test in a licensed laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited.
Currently, CNMs who work independently at certain facilities including alternative birth centers, where there is not a physician and surgeon owner, and therefore no licensed laboratory director, report that they are unable to provide routine, standard tests unless they contract with a physician and surgeon who is willing to lend their license to the facility simply for oversight purposes. As specified in BPC Section 2746.51(f), a CNM may directly procure supplies and devices, obtain and administer diagnostic tests, directly obtain and administer nonscheduled drugs consistent with the provision of services that fall within the scope of services, as specified, order laboratory and diagnostic testing, and receive reports that are necessary to their practice as a certified nurse-midwife within their scope of practice as specified within the certificate to practice midwifery. However, the author and sponsor note difficulties in administering tests.
This bill adds a CNM to the current list of individuals who may be a laboratory director and eligible to perform clinical tests classified as waived and those very specific PPM tests that are permitted only under the CNM’s certificate to practice midwifery.
Comments
According to the author, “This bill removes unnecessary barriers and supervision rules for nurse-midwifery practice, consistent with what SB 1237 (Dodd) did in 2020. In the same way that a CNM can furnish/prescribe medications within the “CNM low-risk scope“ without a standardized procedure, this bill would allow controlled substances for treatment of conditions within the CNM low-risk scope to also be furnished without the administrative barrier of a standardized procedure.” The Author also noted that the various issues the measure sought to resolve “typically involve delays in patient care and treatment, and the ability of independent nurse-midwifery practices to exist, simply due to unnecessary administrative barriers or supervisory requirements that SB 1237 (Dodd, 2020) aimed to solve.”
The amendments to this bill taken on May 24 related to furnishing controlled substances revert to the model under current law, which this bill previously sought to update in order to ensure that CNMs have full independent practice authority, within the scope of their education and training, to provide care to their patients. Now, CNMs will still be required to have “mutually agreed upon policies and protocols” with a physician in order to furnish certain medication, and fully care for their patients.
The BRN states that it supports this bill if it amended to clarify that when a CNM is providing intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium, it be done with a physician and surgeon under mutually agreed upon policies and protocols.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
According to the Assembly Appropriations Committee, the bill will result in minor and absorbable costs to CDPH and will not result in costs to BRN and Medical Board of California.
SUPPORT: (Verified 9/8/23)
2020 Mom
American Association of Birth Centers
American Association of University Women - California
American Nurses Association/California
Best Start Birth Center
California Association for Nurse Practitioners
California Association of Nurse Anesthetists
California Nurse-Midwives Association
NARAL Pro-Choice California
National Health Law Program
Purchaser Business Group on Health
San Francisco Black, Jewish and Unity Group
Training in Early Abortion for Comprehensive Health Care
OPPOSITION: (Verified 9/8/23)
None received
ARGUMENTS IN SUPPORT: Supporters believe that this bill addresses the redundancies, and red tape revealed only through the everyday practice of midwives who continue to experience disruptive and unnecessary limitations to practice. According to supporters, this bill also strengthens continuity and access by clarifying the ability of CNMs to dispense drugs that are consistent with their scope of practice and current prescribing capabilities. It also reduces costly barriers that threaten the sustainability of birth centers and midwife-owned clinics by exempting these specific clinics from California rules that require a physician to be the laboratory director. This bill seeks to reduce geographic and economic barriers to reproductive health care by extending the ability of CNMs to manage common gynecologic conditions across the lifespan rather than only within the discrete periods of pregnancy and conception.
ASSEMBLY FLOOR: 79-0, 9/12/23
AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Jones-Sawyer, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Wicks, Wilson, Wood, Zbur, Robert Rivas
NO VOTE RECORDED: Weber
Prepared by: Elissa Silva / B., P. & E.D. /
9/12/23 19:29:58
**** END ****
SENATE THIRD READING
STR Bill Id:SB 667
Author:(Dodd)
As Amended Ver:September 7, 2023
Majority vote
SUMMARY
Makes various clarifications and changes to the practice and supervision of certified nurse-midwives (CNMs).
Major Provisions
- Expands the definition of "laboratory director" to include CNMs for purposes of a clinical laboratory test or examination classified as waived or PPMP under CLIA.
- Expends the scope of practice for CNMs to include common gynecologic conditions.
- Clarifies that CNMs practicing under mutually agreed-upon policies and protocols with a physician and surgeon are not required to practice with a physician and surgeon.
- Authorizes CNMs to furnish or order Schedule II or III controlled substances under mutually agreed-upon policies and protocols with a physician and surgeon rather than patient-specific protocols approved by a physician and surgeon or standardized procedures.
- Authorizes CNMs to dispense drugs under mutually agreed-upon policies and protocols with a physician and surgeon rather than standardized procedures.
- Includes CNMs in the definition of "prescriber" under the Pharmacy Law.
- Expands the definition of "practitioner" for purposes of whether a CNM or licensed midwife may establish medical eligibility for disability benefits from "normal pregnancy or childbirth" to "pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure."
- Address chaptering conflicts with two bills that amend the same sections, AB 575 (Papan) and SB 345 (Skinner) of the current legislative session.
COMMENTS
Background. CNMs are licensed registered nurses (RNs) with additional training in the field of obstetrics and certification by the American Midwifery Certification Board or an equivalent program. As a result of their additional training, they are considered advanced practice RNs.
As a result of that training, CNMs are also specifically authorized to perform midwifery services and attend cases of low-risk pregnancies and childbirth. CNMs provide midwifery and nursing services in many settings, including the home, birth centers, clinics, and hospitals.
Midwifery. Midwifery is a healthcare profession dealing with maternal care, similar to obstetrics. According to the World Health Organization, midwifery includes the care of a person during pregnancy, labor, and the postpartum/postnatal period, including care of the newborn. Midwifery providers aim to prevent health problems in pregnancy, detect abnormal conditions, seek medical assistance when necessary, and provide emergency services when medical help is unavailable.
On its own, midwifery care is not technically the practice of medicine. While pregnancy may create additional physical and emotional stress, it is not an illness or ailment requiring medical treatment under normal circumstances. Instead, CNMs monitor for abnormal conditions and provide preventive care. A pregnancy without abnormal conditions is called a "low-risk" pregnancy, and CNMs are authorized to independently provide all services and care incidental to a low-risk pregnancy.
CNMs are also authorized to provide services in cases of "high-risk" pregnancies but must do so under mutually agreed-upon policies and procedures with a physician. According to the National Institutes of Health (NIH), "high-risk pregnancy refers to anything that puts the mother or fetus at increased risk for poor health during pregnancy or childbirth. A pregnancy is considered high risk if the mother has chronic health conditions such as high blood pressure or diabetes, or if she weighs too much or too little. Any pregnancy where complications are more likely than normal is considered a high-risk pregnancy." The mutually agreed-upon policies and protocols ensure that medical care can be provided if abnormal conditions or emergencies arise.
This bill would clarify that a CNM does not have to be in the same practice as a physician to establish mutually agreed-upon policies and protocols. This bill would also clarify that hospitals are allowed to grant admitting and discharge privileges to CNMs.
Furnishing or Ordering Drugs and Devices. Existing law authorizes CNMs to provide drugs and devices to patients as part of their midwifery care, but requires them to establish written standardized procedures with a physician or health system for certain drugs, even if they have mutually agreed-upon policies and procedures developed with and signed by a physician. This bill would delete the requirement for separate standardized procedures and allow for the furnishing of those drugs under mutually agreed-upon policies and protocols. It would also add CNMs to the definition of "prescriber" for purposes of the Pharmacy Law.
CLIA. Existing law generally limits the use of laboratory testing because the tests are used in the diagnostic process. The purpose of CLIA and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things.
At both the federal and state level, a facility that performs laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.
The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.
The United States Food and Drug Administration (FDA) determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk of incorrect results. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, the knowledge required, and the types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.
CNMs are currently authorized to perform provider-performed microscopy procedures (PPMP) under standardized procedures, as well as waived and moderate complexity tests under the overall operation and administration of the laboratory director, who is typically a physician or clinical laboratory scientist.
This bill would authorize CNMs to act as the laboratory director for purposes of independent midwifery care for waived and PPMP only. According to the sponsors, the waived tests performed by CNMs at birth centers include:
- Pregnancy tests.
- Hemoglobin by fingerstick.
- Urinalysis dipstick for ketones, nitrites, leukocytes, and nitrites.
- Glucose by finger stick.
- Fecal occult blood.
- Ovulation tests.
PPMP includes four simple tests:
- The Fern Tes, which involves looking at vaginal secretions under the microscope to diagnose that the water bag has broken.
- Looking at a "wet mount" (slide) of vaginal secretions under the microscope to diagnose a common vaginitis called bacterial vaginosis.
- Looking at a wet mount of vaginal secretions to diagnose a yeast infection.
- Looking at a wet mount of vaginal secretions to diagnose a sexually transmitted infection called trichomoniasis.
Medical Eligibility for Disability. Existing law authorizes CNMs to establish medical eligibility for disability in cases of "normal" pregnancy or childbirth. This bill would update the law to reflect the scope of practice of CNMs.
According to the Author
This bill "builds upon the recent efforts by the legislature to expand access to women's health care across the state by removing barriers and ensuring [CNMs] can practice to the full extent of their scope and training. [This] bill removes and streamlines redundant requirements and creates consistency for CNMs regardless of practice setting. There is a direct link between race, access, and maternity outcomes in minority communities. Improving access to nurse-midwifery care has been named by leading organizations, such as the March of Dimes and the World Health Organization, as one of the most innovative strategies in addressing racial disparities in communities of color. In the face of these persistent disparities in maternity care and ongoing provider shortages, [this bill] improves access to care for birthing people by ensuring CNMs can truly practice with full independence within their low-risk scope no matter the care setting and preserves the ability to collaborate with physicians to provide care to patients with more complex needs."
Arguments in Support
The California Nurse-Midwives Association (CNMA) and Black women for Wellness Action Project (co-sponsors) write in support, "This bill builds upon recent expansions to maternity care by Certified Nurse Midwives (CNMs) who can now practice fully independently for "normal," low-risk pregnancies and can also collaborate with physicians to provide care to patients with more complex medical needs. One piece of the solution is to allow these highly qualified providers to practice to the full extent of their scope as the original law establishing independent practice intended. The bill addresses redundancies and red tape revealed only through the everyday practice by midwives who experienced disruptive and unnecessary limitations to practice that SB 1237 (Dodd), Chaptered, 2020 intended to address…. For example, low-risk pregnant patients often need temporary disability certification for common pregnancy conditions that require them to take time off work, such as the RN in an Emergency Department whose back pain at 34 weeks keeps her from lifting patients, or a kindergarten teacher who has significant nausea and vomiting in the initial weeks of pregnancy. While these are typical conditions of pregnancy, the CNM cannot currently certify temporary disability for them. This unnecessary requirement disrupts and delays patient care, especially in health provider shortage areas, and burdens physicians with these approvals that otherwise fall within the scope and training of CNMs."
Arguments in Opposition
None on file
FISCAL COMMENTS
According to the Assembly Appropriations Committee:
- Minor and absorbable costs to the California Department of Public Health.
- No costs to the Board of Registered Nursing (BRN) and Medical Board of California.
VOTES
SENATE FLOOR: 40-0-0
YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk
ASM BUSINESS AND PROFESSIONS: 18-0-1
YES: Berman, Flora, Alanis, Alvarez, Bains, Bonta, Chen, Dixon, Gipson, Grayson, Irwin, Jackson, Lee, Lowenthal, McCarty, McKinnor, Stephanie Nguyen, Joe Patterson
ABS, ABST OR NV: Ting
ASM APPROPRIATIONS: 15-0-1
YES: Holden, Megan Dahle, Bonta, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Soria, Weber, Wilson
ABS, ABST OR NV: Bryan
UPDATED
VERSION: September 7, 2023
CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001959
SENATE THIRD READING
STR Bill Id:SB 667
Author:(Dodd)
As Amended Ver:May 24, 2023
Majority vote
SUMMARY
Makes various clarifications and changes to the practice and supervision of certified nurse-midwives (CNMs).
Major Provisions
- Expands the definition of "laboratory director" to include CNMs for purposes of a clinical laboratory test or examination classified as waived or PPMP under CLIA.
- Expends the scope of practice for CNMs to include common gynecologic conditions.
- Clarifies that CNMs practicing under mutually agreed-upon policies and protocols with a physician and surgeon are not required to practice with a physician and surgeon.
- Authorizes CNMs to furnish or order Schedule II or III controlled substances under mutually agreed-upon policies and protocols with a physician and surgeon rather than patient-specific protocols approved by a physician and surgeon or standardized procedures.
- Authorizes CNMs to dispense drugs under mutually agreed-upon policies and protocols with a physician and surgeon rather than standardized procedures.
- Includes CNMs in the definition of "prescriber" under the Pharmacy Law.
- Expands the definition of "practitioner" for purposes of whether a CNM or licensed midwife may establish medical eligibility for disability benefits from "normal pregnancy or childbirth" to "pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure."
COMMENTS
Background. CNMs are licensed registered nurses (RNs) with additional training in the field of obstetrics and certification by the American Midwifery Certification Board or an equivalent program. As a result of their additional training, they are considered advanced practice RNs.
As a result of that training, CNMs are also specifically authorized to perform midwifery services and attend cases of low-risk pregnancies and childbirth. CNMs provide midwifery and nursing services in many settings, including the home, birth centers, clinics, and hospitals.
Midwifery. Midwifery is a healthcare profession dealing with maternal care, similar to obstetrics. According to the World Health Organization, midwifery includes the care of a person during pregnancy, labor, and the postpartum/postnatal period, including care of the newborn. Midwifery providers aim to prevent health problems in pregnancy, detect abnormal conditions, seek medical assistance when necessary, and provide emergency services when medical help is unavailable.
On its own, midwifery care is not technically the practice of medicine. While pregnancy may create additional physical and emotional stress, it is not an illness or ailment requiring medical treatment under normal circumstances. Instead, CNMs monitor for abnormal conditions and provide preventive care. A pregnancy without abnormal conditions is called a "low-risk" pregnancy, and CNMs are authorized to independently provide all services and care incidental to a low-risk pregnancy.
CNMs are also authorized to provide services in cases of "high-risk" pregnancies but must do so under mutually agreed-upon policies and procedures with a physician. According to the National Institutes of Health (NIH), "high-risk pregnancy refers to anything that puts the mother or fetus at increased risk for poor health during pregnancy or childbirth. A pregnancy is considered high risk if the mother has chronic health conditions such as high blood pressure or diabetes, or if she weighs too much or too little. Any pregnancy where complications are more likely than normal is considered a high-risk pregnancy." The mutually agreed-upon policies and protocols ensure that medical care can be provided if abnormal conditions or emergencies arise.
This bill would clarify that a CNM does not have to be in the same practice as a physician to establish mutually agreed-upon policies and protocols. This bill would also clarify that hospitals are allowed to grant admitting and discharge privileges to CNMs.
Furnishing or Ordering Drugs and Devices. Existing law authorizes CNMs to provide drugs and devices to patients as part of their midwifery care, but requires them to establish written standardized procedures with a physician or health system for certain drugs, even if they have mutually agreed-upon policies and procedures developed with and signed by a physician. This bill would delete the requirement for separate standardized procedures and allow for the furnishing of those drugs under mutually agreed-upon policies and protocols. It would also add CNMs to the definition of "prescriber" for purposes of the Pharmacy Law.
CLIA. Existing law generally limits the use of laboratory testing because the tests are used in the diagnostic process. The purpose of CLIA and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things.
At both the federal and state level, a facility that performs laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.
The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.
The United States Food and Drug Administration (FDA) determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk of incorrect results. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, the knowledge required, and the types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.
CNMs are currently authorized to perform provider-performed microscopy procedures (PPMP) under standardized procedures, as well as waived and moderate complexity tests under the overall operation and administration of the laboratory director, who is typically a physician or clinical laboratory scientist.
This bill would authorize CNMs to act as the laboratory director for purposes of independent midwifery care for waived and PPMP only. According to the sponsors, the waived tests performed by CNMs at birth centers include:
- Pregnancy tests.
- Hemoglobin by fingerstick.
- Urinalysis dipstick for ketones, nitrites, leukocytes, and nitrites.
- Glucose by finger stick.
- Fecal occult blood.
- Ovulation tests.
PPMP includes four simple tests:
- The Fern Tes, which involves looking at vaginal secretions under the microscope to diagnose that the water bag has broken.
- Looking at a "wet mount" (slide) of vaginal secretions under the microscope to diagnose a common vaginitis called bacterial vaginosis.
- Looking at a wet mount of vaginal secretions to diagnose a yeast infection.
- Looking at a wet mount of vaginal secretions to diagnose a sexually transmitted infection called trichomoniasis.
Medical Eligibility for Disability. Existing law authorizes CNMs to establish medical eligibility for disability in cases of "normal" pregnancy or childbirth. This bill would update the law to reflect the scope of practice of CNMs.
According to the Author
This bill "builds upon the recent efforts by the legislature to expand access to women's health care across the state by removing barriers and ensuring [CNMs] can practice to the full extent of their scope and training. [This] bill removes and streamlines redundant requirements and creates consistency for CNMs regardless of practice setting. There is a direct link between race, access, and maternity outcomes in minority communities. Improving access to nurse-midwifery care has been named by leading organizations, such as the March of Dimes and the World Health Organization, as one of the most innovative strategies in addressing racial disparities in communities of color. In the face of these persistent disparities in maternity care and ongoing provider shortages, [this bill] improves access to care for birthing people by ensuring CNMs can truly practice with full independence within their low-risk scope no matter the care setting and preserves the ability to collaborate with physicians to provide care to patients with more complex needs."
Arguments in Support
The California Nurse-Midwives Association (CNMA) and Black women for Wellness Action Project (co-sponsors) write in support, "This bill builds upon recent expansions to maternity care by Certified Nurse Midwives (CNMs) who can now practice fully independently for "normal," low-risk pregnancies and can also collaborate with physicians to provide care to patients with more complex medical needs. One piece of the solution is to allow these highly qualified providers to practice to the full extent of their scope as the original law establishing independent practice intended. The bill addresses redundancies and red tape revealed only through the everyday practice by midwives who experienced disruptive and unnecessary limitations to practice that SB 1237 (Dodd, Chaptered, 2020) intended to address…. For example, low-risk pregnant patients often need temporary disability certification for common pregnancy conditions that require them to take time off work, such as the RN in an Emergency Department whose back pain at 34 weeks keeps her from lifting patients, or a kindergarten teacher who has significant nausea and vomiting in the initial weeks of pregnancy. While these are typical conditions of pregnancy, the CNM cannot currently certify temporary disability for them. This unnecessary requirement disrupts and delays patient care, especially in health provider shortage areas, and burdens physicians with these approvals that otherwise fall within the scope and training of CNMs."
Arguments in Opposition
None on file
FISCAL COMMENTS
According to the Assembly Appropriations Committee:
- Minor and absorbable costs to the California Department of Public Health.
- No costs to the Board of Registered Nursing (BRN) and Medical Board of California.
VOTES
SENATE FLOOR: 40-0-0
YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk
ASM BUSINESS AND PROFESSIONS: 18-0-1
YES: Berman, Flora, Alanis, Alvarez, Bains, Bonta, Chen, Dixon, Gipson, Grayson, Irwin, Jackson, Lee, Lowenthal, McCarty, McKinnor, Stephanie Nguyen, Joe Patterson
ABS, ABST OR NV: Ting
ASM APPROPRIATIONS: 15-0-1
YES: Holden, Megan Dahle, Bonta, Wendy Carrillo, Dixon, Mike Fong, Hart, Lowenthal, Mathis, Papan, Pellerin, Sanchez, Soria, Weber, Wilson
ABS, ABST OR NV: Bryan
UPDATED
VERSION: May 24, 2023
CONSULTANT: Vincent Chee / B. & P. / (916) 319-3301 FN: 0001221
Date of Hearing: July 12, 2023
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Chris Holden, Chair
SBPCA Bill Id:SB 667
Author:(Dodd) – As Amended Ver:May 24, 2023
Policy Committee: | Business and Professions | Vote: | 18 - 0 |
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Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill expands and clarifies the scope of practice of certified nurse-midwives (CNMs).
Specifically, this bill:
- Clarifies that CNMs practicing under mutually agreed-upon policies and protocols with a physician are not required to practice with a physician.
- Authorizes CNMs to furnish or order Schedule II or III controlled substances under mutually agreed-upon policies and protocols with a physician rather than patient-specific protocols approved by a physician or standardized procedures.
- Authorizes CNMs to dispense drugs under mutually agreed-upon policies and protocols with a physician rather than standardized procedures.
- Includes CNMs in the definition of “prescriber” under the Pharmacy Law.
- Expands the definition of “laboratory director” to include CNMs for purposes of a clinical laboratory test or examination classified as waived or provider-performed microscopy procedures (PPMP) under the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA).
FISCAL EFFECT:
- Minor and absorbable costs to the California Department of Public Health.
- No costs to the Board of Registered Nursing (BRN) and Medical Board of California.
COMMENTS:
- Purpose. This bill is co-sponsored by the California Nurse-Midwives Association and Black Women for Wellness Action Project. According to the author:
SB 667 builds upon the recent efforts by the legislature to expand access to women’s health care across the state by removing barriers and ensuring Certified Nurse Midwives (CNMs) can practice to the full extent of their scope and training. The bill removes and streamlines redundant requirements and creates consistency for CNMs regardless of practice setting. There is a direct link between race, access, and maternity outcomes in minority communities. Improving access to nurse-midwifery care has been named by leading organizations, such as the March of Dimes and the World Health Organization, as one of the most innovative strategies in addressing racial disparities in communities of color. In the face of these persistent disparities in maternity care and ongoing provider shortages, SB 667 improves access to care for birthing people by ensuring CNMs can truly practice with full independence within their low-risk scope no matter the care setting and preserves the ability to collaborate with physicians to provide care to patients with more complex needs.
- Background.
CNMs. CNMs are licensed registered nurses (RNs) with additional training in obstetrics and certification by the American Midwifery Certification Board or an equivalent program. CNMs provide midwifery and nursing services in many settings, including the home, birth centers, clinics, and hospitals. CNMs are considered advanced practice RNs. CNMs are also specifically authorized to perform midwifery services and attend cases of low-risk pregnancies and childbirth. CNMs monitor for abnormal conditions and provide preventive care. A pregnancy without abnormal conditions is called a low-risk pregnancy, and CNMs are authorized to independently provide all services and care incidental to a low-risk pregnancy.
CNMs are authorized to provide services for high-risk pregnancies under mutually agreed-upon policies and procedures with a physician. Any pregnancy where complications are more likely than normal, such as when the mother has high blood pressure or diabetes, or is overweight or underweight, is considered a high-risk pregnancy. Mutually agreed-upon policies and protocols ensure that medical care can be provided if abnormal conditions or emergencies arise.
Midwifery. Midwifery is a maternal health profession that includes care during pregnancy, labor, and the postpartum/postnatal period, including care of the newborn. Midwifery providers aim to prevent health problems in pregnancy, detect abnormal conditions, seek medical assistance when necessary, and provide emergency services when medical help is unavailable. Midwifery care is not technically the practice of medicine, as pregnancy is not an illness or ailment requiring medical treatment under normal circumstances.
Laboratory Testing. CNMs are authorized to perform PPMP under standardized procedures, as well as waived and moderate complexity tests under the overall operation and administration of the laboratory director. This bill authorizes CNMs to act as the laboratory director for purposes of independent midwifery care for waived tests and PPMP. According to the sponsors, the waived tests performed by CNMs at birth centers include: pregnancy tests; hemoglobin by fingerstick; urinalysis dipstick for ketones, nitrites, leukocytes, and nitrites; glucose by finger stick; fecal occult blood; and ovulation tests. PPMP includes four simple tests, all of which are microscopic examinations of vaginal secretions: the fern test, to detect rupture of the membranes (“water breaking”); diagnosis of bacterial vaginosis; diagnosis of yeast infection; and diagnosis of trichomoniasis, a sexually transmitted infection.
- Prior Legislation.
- SB 1237 (Dodd), Chapter 88, Statutes of 2020, authorized CNMs to attend to low-risk pregnancies and perform related incidental functions without physician supervision; replaced the supervision requirement for higher-risk pregnancies with mutually agreed-upon policies and protocols; required the BRN to establish a Nurse-Midwifery Advisory Committee; established a disclosure and informed consent requirement; and established reporting and data collection requirements.
- AB 2682 (Burke), of the 2017-18 Legislative Session, would have authorized a CNM to attend cases of normal pregnancy and childbirth without the supervision of a physician, required the BRN to establish a nurse-midwifery practice committee, and made conforming changes to childbirth attendance requirements for naturopathic doctors. AB 2682 died pending a hearing in the Senate Business, Professions and Economic Development Committee.
- AB 1612 (Burke), of the 2017-18 Legislative Session, would have substantially expanded the scope of practice for a CNM related to drugs and devices, procurement of supplies and devices, obtaining and administering drugs and diagnostic tests, and authorized a CNM to perform and repair episiotomies and to repair first-degree and second-degree lacerations of the perineum, as specified. AB 1612 died pending a hearing in the Assembly Appropriations Committee.
- SB 457 (Bates), of the 2017-18 Legislative Session, would have revised the requirements for physicians, licensed midwives, and CNMs who attend cases of pregnancy and out-of-hospital childbirth by specifying risk factors, referral requirements, and settings. SB 457 died pending hearing in the Senate Business, Professions and Economic Development Committee.
- AB 1306 (Burke), of the 2015-16 Legislative Session, would have removed specified physician supervision requirements for CNMs, increased educational requirements, modified practice parameters, established a Nurse-Midwifery Advisory Committee within the BRN, among other changes. AB 1306 failed on concurrence on the Assembly floor.
- SB 1237 (Dodd), Chapter 88, Statutes of 2020, authorized CNMs to attend to low-risk pregnancies and perform related incidental functions without physician supervision; replaced the supervision requirement for higher-risk pregnancies with mutually agreed-upon policies and protocols; required the BRN to establish a Nurse-Midwifery Advisory Committee; established a disclosure and informed consent requirement; and established reporting and data collection requirements.
Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081
Date of Hearing: June 27, 2023
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Marc Berman, Chair
SBPCA Bill Id:SB 667
Author:(Dodd) – As Amended Ver:May 24, 2023
SENATE VOTE: 40-0
SUBJECT: Healing arts: pregnancy and childbirth
SUMMARY: Makes various clarifications and changes to the practice and supervision of certified nurse-midwives (CNMs).
EXISTING LAW:
- Regulates and licenses the practice of nursing under the Nursing Practice Act, which is administered and enforced by the Board of Registered Nursing (BRN). (Business and Professions Code (BPC) §§ 2700-2838.4)
- Establishes the following related to nursing scope of practice:
- Defines “the practice of nursing” as those functions, including basic health care, that help people cope with difficulties in daily living that are associated with their actual or potential health or illness problems or the relevant treatment, and that require a substantial amount of scientific knowledge or technical skill, including all of the following:
- Direct and indirect patient care services that ensure the safety, comfort, personal hygiene, and protection of patients; and the performance of disease prevention and restorative measures. (BPC § 2725(b)(1))
- Direct and indirect patient care services, including, but not limited to, the administration of medications and therapeutic agents, necessary to implement a treatment, disease prevention, or rehabilitative regimen ordered by and within the scope of licensure of a physician, dentist, podiatrist, or clinical psychologist, as defined. (BPC § 2725(b)(2))
- The performance of skin tests, immunization techniques, and the withdrawal of human blood from veins and arteries. (BPC § 2725(b)(3))
- Observation of signs and symptoms of illness, reactions to treatment, general behavior, or general physical condition, and (A) determination of whether the signs, symptoms, reactions, behavior, or general appearance exhibit abnormal characteristics, and (B) implementation, based on observed abnormalities, of appropriate reporting, or referral, or standardized procedures, or changes in treatment regimen in accordance with standardized procedures, or the initiation of emergency procedures. (BPC § 2725(b)(4))
- Defines “standardized procedures” as either of the following:
- Policies and protocols developed by a licensed health facility through collaboration among administrators and health professionals including physicians and nurses. (BPC § 2725(c)(1))
- Policies and protocols developed through collaboration among administrators and health professionals, including physicians and nurses, by an organized health care system which is not a licensed health facility, subject to any guidelines for standardized procedures established by the Medical Board of California and the BRN. (BPC § 2725(c)(2))
- Establishes standardized procedure guidelines jointly promulgated by the Medical Board of California and the BRN. (California Code of Regulations (CCR), Title 16, § 1474)
- Requires standardized procedures to include a written description of the method used during development and approval. (CCR, tit. 16, § 1474(a))
- Specifies the required form and content of standardized procedures, including that they be in writing and signed, specify the authorized functions, establish procedure protocols, detail education and training requirements, provide for evaluation and of authorized nurses, provide for the maintenance of records of authorized nurses, establish the scope of physician supervision, set forth circumstances requiring physician consultation, state limitations on settings, specify patient record keeping requirements, and provide for periodic review of the standardized procedures. (CCR, tit. 16, § 1474(b))
- Defines “the practice of nursing” as those functions, including basic health care, that help people cope with difficulties in daily living that are associated with their actual or potential health or illness problems or the relevant treatment, and that require a substantial amount of scientific knowledge or technical skill, including all of the following:
- Requires the BRN to issue a certificate to practice nurse-midwifery to anyone who meets the statutory requirements for CNMs and meets the BRN’s educational standards. (BPC §§ 2746, 2746.1, 2746.2(a))
- Establishes the following related to CNM scope of practice:
- Authorizes a CNM 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, 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 BRN. (BPC § 2746.5(a))
- Defines “low-risk pregnancy” as a pregnancy in which all of the following conditions are met:
- There is a single fetus. (BPC § 2746.5(a)(1))
- There is a cephalic presentation at onset of labor. (BPC § 2746.5(a)(2))
- 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. (BPC § 2746.5(a)(3))
- Labor is spontaneous or induced. (BPC § 2746.5(a)(4))
- The patient has no preexisting disease or condition, whether arising out of the pregnancy or otherwise, that adversely affects the pregnancy and that the CNM is not qualified to independently address. (BPC § 2746.5(a)(5))
- Authorizes a CNM to provide specified services in cases of non-low-risk pregnancy and childbirth under 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 CNM and a physician and surgeon and specifies various conditions and requirements when providing those services. (BPC §§ 2746.5(b)-(c))
- Authorizes a CNM to order, furnish, and dispense drugs or devices incidental to the provision of care and services for low-risk pregnancy and childbirth and specifies the conditions under which standardized procedures are required. (BPC §§ 2746.51, 4170)
- Defines “CLIA” as the federal Clinical Laboratory Improvement Amendments of 1988 and the relevant regulations adopted by the federal Health Care Financing Administration that are also adopted by the California Department of Public Health (CDPH). (BPC § 1202.5(a))
- Regulates clinical laboratories and the performance of clinical laboratory tests through the licensing of clinical laboratories and laboratory directors, scientists, and other laboratory personnel under the CDPH and CLIA. (BPC §§ 1200-1327)
- Requires every clinical laboratory to have a laboratory director who is responsible for the overall operation and administration of the clinical laboratory, including (1) 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 state clinical laboratory laws and CLIA, (2) the proper performance of all laboratory work of all subordinates, and (3) employing 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 state clinical laboratory laws. (BPC § 1209(d)(1))
- Defines “laboratory director,” for purposes of a clinical laboratory test or examination classified as waived, as any of the following:
- A duly licensed clinical laboratory scientist. (BPC § 1209(a)(2)(A))
- A duly licensed limited clinical laboratory scientist. (BPC § 1209(a)(2)(B))
- A duly licensed naturopathic doctor. (BPC § 1209(a)(2)(C))
- A duly licensed optometrist serving as the director of a laboratory that only performs specified clinical laboratory tests. (BPC § 1209(a)(2)(D))
- 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. (BPC § 1209(a)(2)(E))
- A pharmacist-in-charge of a pharmacy serving as the director of a laboratory that only performs waived tests. (BPC § 1209(a)(2)(F))
- Authorizes a licensed nurse to perform clinical laboratory tests classified as waived or of moderate complexity. (BPC § 1206.5)
- Authorizes a CNM, nurse practitioner, or physician assistant to perform clinical laboratory examinations classified as provider-performed microscopy procedures (PPMP) under CLIA to be personally performed using a brightfield or phase/contrast microscope under physician supervision or protocols 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 CNM, licensed nurse practitioner, or licensed physician assistant is an employee. (BPC § 1206.5(d)(3))
- Defines “prescriber,” for purposes of the pharmacy law, to mean 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, or a certificate to practice as a nurse practitioner without standardized procedures, 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. (BPC § 4170(c))
- Defines “practitioner,” for purposes of establishing medical eligibility for unemployment insurance, to include a midwife or CNM in cases of normal pregnancy or childbirth. (Unemployment Insurance Code § 2708(e)(2)(A))
THIS BILL:
- Expands the definition of “laboratory director” to include CNMs for purposes of a clinical laboratory test or examination classified as waived or PPMP under CLIA.
- Expends the scope of practice for CNMs to include common gynecologic conditions.
- Clarifies that CNMs practicing under mutually agreed-upon policies and protocols with a physician and surgeon are not required to practice with a physician and surgeon.
- Authorizes CNMs to furnish or order Schedule II or III controlled substances under mutually agreed-upon policies and protocols with a physician and surgeon rather than patient-specific protocols approved by a physician and surgeon or standardized procedures.
- Authorizes CNMs to dispense drugs under mutually agreed-upon policies and protocols with a physician and surgeon rather than standardized procedures.
- Includes CNMs in the definition of “prescriber” under the Pharmacy Law.
- Expands the definition of “practitioner” for purposes of whether a CNM or licensed midwife may establish medical eligibility for disability benefits from “normal pregnancy or childbirth” to “pregnancy, childbirth, or postpartum conditions consistent with the scope of their professional licensure.”
FISCAL EFFECT: According to the Senate Appropriations Committee, pursuant to Senate Rule 28.8, no significant state costs anticipated.
COMMENTS:
Purpose. This bill is co-sponsored by the California Nurse-Midwifes Association and Black Women for Wellness Action Project. According to the author, this bill “builds upon the recent efforts by the legislature to expand access to women’s health care across the state by removing barriers and ensuring [CNMs] can practice to the full extent of their scope and training. [This] bill removes and streamlines redundant requirements and creates consistency for CNMs regardless of practice setting. There is a direct link between race, access, and maternity outcomes in minority communities. Improving access to nurse-midwifery care has been named by leading organizations, such as the March of Dimes and the World Health Organization, as one of the most innovative strategies in addressing racial disparities in communities of color. In the face of these persistent disparities in maternity care and ongoing provider shortages, [this bill] improves access to care for birthing people by ensuring CNMs can truly practice with full independence within their low-risk scope no matter the care setting and preserves the ability to collaborate with physicians to provide care to patients with more complex needs.”
Background. CNMs are licensed registered nurses (RNs) with additional training in the field of obstetrics and certification by the American Midwifery Certification Board or an equivalent program. As a result of their additional training, they are considered advanced practice RNs.
As a result of that training, CNMs are also specifically authorized to perform midwifery services and attend cases of low-risk pregnancies and childbirth. CNMs provide midwifery and nursing services in many settings, including the home, birth centers, clinics, and hospitals.
Midwifery. Midwifery is a healthcare profession dealing with maternal care, similar to obstetrics. According to the World Health Organization, midwifery includes the care of a person during pregnancy, labor, and the postpartum/postnatal period, including care of the newborn. Midwifery providers aim to prevent health problems in pregnancy, detect abnormal conditions, seek medical assistance when necessary, and provide emergency services when medical help is unavailable.
On its own, midwifery care is not technically the practice of medicine. While pregnancy may create additional physical and emotional stress, it is not an illness or ailment requiring medical treatment under normal circumstances. Instead, CNMs monitor for abnormal conditions and provide preventive care. A pregnancy without abnormal conditions is called a “low-risk” pregnancy, and CNMs are authorized to independently provide all services and care incidental to a low-risk pregnancy.
CNMs are also authorized to provide services in cases of “high-risk” pregnancies but must do so under mutually agreed-upon policies and procedures with a physician. According to the National Institutes of Health (NIH), “high-risk pregnancy refers to anything that puts the mother or fetus at increased risk for poor health during pregnancy or childbirth. A pregnancy is considered high risk if the mother has chronic health conditions such as high blood pressure or diabetes, or if she weighs too much or too little. Any pregnancy where complications are more likely than normal is considered a high-risk pregnancy.” The mutually agreed-upon policies and protocols ensure that medical care can be provided if abnormal conditions or emergencies arise.
This bill would clarify that a CNM does not have to be in the same practice as a physician to establish mutually agreed-upon policies and protocols. This bill would also clarify that hospitals are allowed to grant admitting and discharge privileges to CNMs.
Furnishing or Ordering Drugs and Devices. Existing law authorizes CNMs to provide drugs and devices to patients as part of their midwifery care, but requires them to establish written standardized procedures with a physician or health system for certain drugs, even if they have mutually agreed-upon policies and procedures developed with and signed by a physician. This bill would delete the requirement for separate standardized procedures and allow for the furnishing of those drugs under mutually agreed-upon policies and protocols. It would also add CNMs to the definition of “prescriber” for purposes of the Pharmacy Law.
CLIA. Existing law generally limits the use of laboratory testing because the tests are used in the diagnostic process. The purpose of CLIA and the California requirements is to minimize the risk of incorrect or unreliable results, patient harm during testing, and improper diagnoses, among other things.
At both the federal and state level, a facility that performs laboratory tests on human specimens for diagnostic or assessment purposes must be certified under CLIA. While CLIA establishes the minimum standards under federal law, it allows states to establish more stringent requirements.
The requirements for CLIA certification vary depending on the complexity of the laboratory tests performed. Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director.
The FDA determines the complexity of laboratory tests under CLIA. Waived tests are simple tests with a low risk of incorrect results. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for a waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, the knowledge required, and the types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process.
CNMs are currently authorized to perform provider-performed microscopy procedures (PPMP) under standardized procedures, as well as waived and moderate complexity tests under the overall operation and administration of the laboratory director, who is typically a physician or clinical laboratory scientist.
This bill would authorize CNMs to act as the laboratory director for purposes of independent midwifery care for waived and PPMP only. According to the sponsors, the waived tests performed by CNMs at birth centers include:
- Pregnancy tests.
- Hemoglobin by fingerstick.
- Urinalysis dipstick for ketones, nitrites, leukocytes, and nitrites.
- Glucose by finger stick.
- Fecal occult blood.
- Ovulation tests.
PPMP includes four simple tests:
- The Fern Tes, which involves looking at vaginal secretions under the microscope to diagnose that the water bag has broken.
- Looking at a "wet mount" (slide) of vaginal secretions under the microscope to diagnose a common vaginitis called bacterial vaginosis.
- Looking at a wet mount of vaginal secretions to diagnose a yeast infection.
- Looking at a wet mount of vaginal secretions to diagnose a sexually transmitted infection called trichomoniasis.
Medical Eligibility for Disability. Existing law authorizes CNMs to establish medical eligibility for disability in cases of “normal” pregnancy or childbirth. This bill would update the law to reflect the scope of practice of CNMs.
Prior Related Legislation. SB 1237 (Dodd), Chapter 88, Statutes of 2020, authorized CNMs to attend to low-risk pregnancies and perform related incidental functions without physician supervision; replaces the supervision requirement for higher-risk pregnancies with mutually agreed-upon policies and protocols; required the Board of Registered Nursing to establish a Nurse-Midwifery Advisory Committee; established a disclosure and informed consent requirement; and established reporting and data collection requirements.
AB 2682 (Burke) of 2018 would have authorized a CNM to attend cases of normal pregnancy and childbirth without the supervision of a physician and surgeon, required BRN to establish a nurse-midwifery practice committee, and made conforming changes to childbirth attendance requirements for naturopathic doctors. AB 2682 died pending a hearing in the Senate Business, Professions and Economic Development Committee.
SB 457 (Bates) of 2017 would have revised the requirements for physicians and surgeons, LMs, and CNMs who attend cases of pregnancy and out-of-hospital childbirth, including specifying risk factors, referral requirements, and settings. SB 457 died pending hearing in the Senate Business, Professions and Economic Development Committee.
AB 1612 (Burke) of 2017 would have: authorized a CNM to furnish and order drugs and devices related to care rendered in a home under standardized procedures and protocols; authorized a CNM to directly procure supplies and devices, to obtain and administer drugs and diagnostic tests, to order laboratory and diagnostic testing, and to receive reports that are necessary to their practice and consistent with nurse-midwifery education preparation; authorized a CNM to perform and repair episiotomies and to repair first-degree and second degree lacerations of the perineum, in a licensed acute care center, as specified, in a home setting and in a birth center accredited by a national accrediting body approved by the BRN; required a CNM when performing those procedures, to ensure that all complications are referred to a physician and surgeon immediately. AB 1612 died pending a hearing in the Assembly Appropriations Committee.
AB 1306 (Burke) of 2016 would have removed specified physician and surgeon supervision requirements for CNMs, increased educational requirements, modified practice parameters, established a Nurse-Midwifery Advisory Committee within the Board of Registered Nursing BRN, and subjected CNMs to the ban on the corporate practice of medicine, as specified, among other changes. AB 1306 failed on concurrence on the Assembly floor.
ARGUMENTS IN SUPPORT:
The California Nurse-Midwives Association (CNMA) and Black women for Wellness Action Project (co-sponsors) write in support, “This bill builds upon recent expansions to maternity care by Certified Nurse Midwives (CNMs) who can now practice fully independently for “normal,” low-risk pregnancies and can also collaborate with physicians to provide care to patients with more complex medical needs. One piece of the solution is to allow these highly qualified providers to practice to the full extent of their scope as the original law establishing independent practice intended. The bill addresses redundancies and red tape revealed only through the everyday practice by midwives who experienced disruptive and unnecessary limitations to practice that SB 1237 (Dodd, Chaptered, 2020) intended to address…. For example, low-risk pregnant patients often need temporary disability certification for common pregnancy conditions that require them to take time off work, such as the RN in an Emergency Department whose back pain at 34 weeks keeps her from lifting patients, or a kindergarten teacher who has significant nausea and vomiting in the initial weeks of pregnancy. While these are typical conditions of pregnancy, the CNM cannot currently certify temporary disability for them. This unnecessary requirement disrupts and delays patient care, especially in health provider shortage areas, and burdens physicians with these approvals that otherwise fall within the scope and training of CNMs.”
ARGUMENTS IN OPPOSITION:
None on file
REGISTERED SUPPORT:
California Nurse Midwives Association (co-sponsor)
Black Women for Wellness Action Project (co-sponsor)
2020 Mom
American Association of Birth Centers
American Association of University Women California
American Nurses Association/California
Best Start Birth Center
California Association for Nurse Practitioners
California Association of Nurse Anesthetists
Citizens for Choice
Maternal and Child Health Access
NARAL Pro-choice California
National Health Law Program
Purchaser Business Group on Health
San Francisco Black, Jewish and Unity Group
Training in Early Abortion for Comprehensive Health Care
Women's Foundation California
Women's Health Specialists
REGISTERED OPPOSITION:
None on file
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301
SENATE RULES COMMITTEE Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | SB 667 |
THIRD READING
Bill No: SB 667
Author: Dodd (D)
Amended: 5/24/23
Vote: 21
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 12-0, 4/17/23
AYES: Roth, Nguyen, Alvarado-Gil, Archuleta, Ashby, Becker, Dodd, Eggman, Niello, Smallwood-Cuevas, Wahab, Wilk
NO VOTE RECORDED: Glazer
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SUBJECT: Healing arts: pregnancy and childbirth
SOURCE: California Nurse-Midwives Association
DIGEST:
This bill clarifies a certified nurse midwife’s (CNM) authority to treat and provide care for common gynecologic conditions; permits a CNM to admit or discharge a patient if a CNM has privileges at a general acute care hospital, as specified; clarifies that a CNM is a practitioner for purposes of certifying disability; and includes a CNMs as a laboratory director for purposes of performing specified laboratory tests, among other technical changes.
Senate Floor Amendments of 5/24/23 maintain existing law for purposes of furnishing or ordering controlled substances, as specified, and make other technical and clarifying changes.
ANALYSIS:
Existing law:
- States that the certificate to practice nurse-midwifery authorizes the holder (CNM) 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. (Business and Professions Code (BPC) § 2745.6(b))
- Permits a CNM to furnish or order drugs or devices, including controlled substances classified in schedule II III IV or V, under the California Uniform Controlled Substances Act when the drugs or devices are furnished or ordered incidentally to the care and services are authorized in the certificate to practice midwifery and when the furnishing or ordering of drugs or devices by a CNM for services that do not fall within the certificate to practice midwifery are in accordance with standardized procedures or protocols, as defined; or a patient-specific protocol approved by a physician and surgeon, as specified. (BPC §2746.51(a))
- Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by the California Department of Public Health, with specified exceptions. (BPC § 1200-1327)
- Prohibits a person from performing a clinical laboratory test or examination classified as waived under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) (CLIA) unless the clinical laboratory test or examination is performed under the overall operation and administration of the laboratory director 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 specified personnel. (BPC § 1206.5(a))
- Defines a “practitioner” for purposes of a claimant establishing medical eligibility for filing a claim for disability benefits supported by the certificate of a treating physician or practitioner. (Unemployment Insurance Code § 2708(a)(1) and 2708(e)(2).
This bill:
- Adds common gynecologic conditions to the practice of midwifery by a CNM.
- Permits a CNM who holds privileges in a general acute care hospital, as defined, to admit and discharge patients upon their own authority, within their scope of practice and in accordance with the organized medical staff bylaws of that facility, as specified.
- Deletes the requirement that a copy of standardized procedure or protocol relating to the furnishing or ordering of controlled substances by a CNM be provided upon request to any licensed pharmacist who is uncertain of the CNM to perform these functions.
- Clarifies that a CNM may dispense drugs, which are defined in the pharmacy law as not dangerous, as specified.
- Adds a CNM to the definition of “prescriber” in the pharmacy law, as specified.
- Adds low-risk pregnancy and childbirth or postpartum conditions consistent with the scope of a CNM’s or midwife’s professional license to the definition of “practitioner” for purposes of obtaining medical eligibility for disability, as specified.
- Adds a CNM to the definition of laboratory director as long as the CNM only performs clinical laboratory tests classified as waived or provider-performed microscopy authorized within the scope of the certificate to practice midwifery, as specified.
- Makes other technical and clarifying changes.
Background
CNMs are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. These individuals are licensed by the BRN, have acquired additional training in the field of obstetrics, and are certified by the American College of Nurse Midwives. In order to obtain a certificate to practice as a CNM, the applicant must provide proof to the BRN that they have either graduated from a BRN approved program in nurse-midwifery or satisfied equivalence standards as set forth in the BRN’s regulations (Title 16 California Code of Regulations § 1460).
The nurse-midwifery certificate authorizes the CNM to attend cases of low-risk pregnancy and childbirth, as well as immediate care for the newborn along with family planning and interconception care. CNMs may furnish or order drugs and devices in certain healthcare settings. If a CNM orders or furnishes a drug or device that would be outside of the standard of care authorized by the certificate to practice midwifery, the CNM may only do so if they have established mutually agreed upon protocols with a physician and surgeon. Additionally, in order to furnish drugs or devices, the CNM must obtain a furnishing number from the BRN, and register with the United States Drug Enforcement Administration and the Controlled Substance Utilization Review and Enforcement System.
Prior to 2020, CNMs were required to practice under the supervision of a physician and surgeon under standardized procedures and protocols. SB 1237 (Dodd, Chapter, Statutes of 2019) eliminated the requirement for a CNM to practice midwifery according to standardized procedures or protocols with a physician in an effort to allow CNMs to practice independently of physician supervision. That bill revised provisions defining the practice of midwifery, authorized a CNM to attend cases of childbirth outside of a define hospital setting; authorized a CNM to furnish or order drugs or devices in accordance with standardized protocols with a physician; required a CNM to provide specified disclosures to a patient; and, established new reporting and data collection requirements. SB 1237 did not change the scope of work that a CMN could perform, but permitted a CNM to perform their work without physician supervision.
This bill adds CNMs to the definition of “practitioner” under the unemployment insurance code to ensure that CNMs can establish eligibility for disability purposes related to low-risk pregnancy, childbirth and postpartum conditions. This bill would also add the care of “common gynecological conditions” to the list of services that a CNM is able to provide based on a certificate to practice midwifery. If a CNM were to provide care for a gynecological condition that falls outside that normal parameter, they would subject themselves to potential enforcement by the BRN. This bill updates the pharmacy law to include CNMs in the definition of “prescriber”, among other provisions.
A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements. At the federal level and in California, anyone may perform a waived test in a licensed laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited.
Currently, CNMs who work independently at certain facilities including alternative birth centers, where there is not a physician and surgeon owner, and therefore no licensed laboratory director, report that they are unable to provide routine, standard tests unless they contract with a physician and surgeon who is willing to lend their license to the facility simply for oversight purposes. As specified in BPC § 2746.51(f), a CNM may directly procure supplies and devices, obtain and administer diagnostic tests, directly obtain and administer nonscheduled drugs consistent with the provision of services that fall within the scope of services, as specified, order laboratory and diagnostic testing, and receive reports that are necessary to their practice as a certified nurse-midwife within their scope of practice as specified within the certificate to practice midwifery. However, the author and sponsor note difficulties in administering tests.
This bill adds a CNM to the current list of individuals who may be a laboratory director and eligible to perform clinical tests classified as waived and those very specific PPM tests that are permitted only under the CNM’s certificate to practice midwifery.
Comments
According to the author, “This bill removes unnecessary barriers and supervision rules for nurse-midwifery practice, consistent with what SB 1237 (Dodd) did in 2020. In the same way that a CNM can furnish/prescribe medications within the “CNM low-risk scope“ without a standardized procedure, this bill would allow controlled substances for treatment of conditions within the CNM low-risk scope to also be furnished without the administrative barrier of a standardized procedure.” The Author also noted that the various issues the measure sought to resolve “typically involve delays in patient care and treatment, and the ability of independent nurse-midwifery practices to exist, simply due to unnecessary administrative barriers or supervisory requirements that SB 1237 (Dodd, 2020) aimed to solve.”
The amendments to this bill taken on May 24 related to furnishing controlled substances revert to the model under current law, which this bill previously sought to update in order to ensure that CNMs have full independent practice authority, within the scope of their education and training, to provide care to their patients. Now, CNMs will still be required to have “mutually agreed upon policies and protocols” with a physician in order to furnish certain medication, and fully care for their patients.
The Board of Registered Nursing states that it supports this bill if it amended to clarify that when a CNM is providing intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium, it be done with a physician and surgeon under mutually agreed upon policies and protocols.
FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No
SUPPORT: (Verified 5/30/23)
California Nurse-Midwives Association (source)
2020 Mom
American Association of Birth Centers
American Association of University Women - California
American Nurses Association/California
Best Start Birth Center
California Association for Nurse Practitioners
California Association of Nurse Anesthetists
NARAL Pro-Choice California
National Health Law Program
Purchaser Business Group on Health
San Francisco Black, Jewish and Unity Group
Training in Early Abortion for Comprehensive Health Care
OPPOSITION: (Verified 5/30/23)
None received
ARGUMENTS IN SUPPORT: Supporters believe that this bill addresses the redundancies, and red tape revealed only through the everyday practice of midwives who continue to experience disruptive and unnecessary limitations to practice. According to supporters, this bill also strengthens continuity and access by clarifying the ability of CNMs to dispense drugs that are consistent with their scope of practice and current prescribing capabilities. It also reduces costly barriers that threaten the sustainability of birth centers and midwife-owned clinics by exempting these specific clinics from California rules that require a physician to be the laboratory director. This bill seeks to reduce geographic and economic barriers to reproductive health care by extending the ability of CNMs to manage common gynecologic conditions across the lifespan rather than only within the discrete periods of pregnancy and conception.
Prepared by: Elissa Silva / B., P. & E.D. / 916-651-4104
5/30/23 9:36:27
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SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Richard Roth, Chair
2023 - 2024 Regular
Bill No: Hearing Date: April 17, 2023
Author: | |||
Version: | April 11, 2023 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | Elissa Silva | ||
Subject:
SUMMARY:
Updates independence practice authority for Certified Nurse Midwives (CNM), and revises authority to furnish or order specified controlled substances within a CNM’s standard of care without a mutually agreed upon policies or procedures, clarifies a CNM’s authority to treat and provide care for common gynecologic conditions, permits a CNM to admit or discharge a patient if a CNM has privileges at a general acute care hospital, as specified, clarifies that a CNM is a practitioner for purposes of certifying disability, and establishes a registration program for alternative birth centers or primary care clinic at the California Department of Public Health (CDPH), to permit those centers to perform CLIA waived tests, as specified.
Existing law:
- Establishes the Board of Registered Nursing (BRN) to provide for the licensure and regulation of the practice of nursing and authorizes the BRN to issue a certificate to practice nurse-midwifery to a person who meets educational standards established by the BRN or the equivalent of those educational standards. (Business and Professions Code (BPC) §§ 2700 et seq.)
- States that the certificate to practice nurse-midwifery authorizes the holder 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.
- Defines “low-risk pregnancy” for purposes of 2) above to mean a pregnancy in which all of the following conditions are met;
- There is a single fetus;
- There is a cephalic presentation at onset of labor;
- 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.
- Labor is spontaneous or induced;
- The patient has no preexisting disease or condition, whether arising out of the pregnancy or otherwise, that adversely affects the pregnancy ad that the certified nurse-midwife is not qualified to independently address. (BPC § 2745.6(b))
- States that the certificate to practice nurse-midwifery authorizes the holder to practice with a physician and surgeon under 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 CNM and a physician and surgeon that do either of the following:
- Provide a patient with care that falls outside the scope of authorized services; and,
- Provide intrapartum care to a patient who has had a prior cesarean section or surgery that interrupts the myometrium. (BPC § 2746.5(b))
- States that the practice of midwifery does not include the assisting of childbirth by vacuum or forceps extraction or to perform any external cephalic version. (BPC § 2746.5(f))
- Permits a CNM to furnish or order drugs or devices, including controlled substances classified in schedule II III IV or V, under the California Uniform Controlled Substances Act when all of the following apply:
- The drugs or devices are furnished or ordered incidentally to the provision of any of the following:
- The care and services are authorized in the certificate to practice midwifery;
- Care rendered consistent with the CNM’s educational preparation or for which clinical competency has been established or maintained, to persons within a specified facility, and,
- Care rendered in an out-of-hospital setting as authorized in the midwifery practice act.
- The furnishing or ordering of drugs or devices by a CNM for services that do not fall within the certificate to practice midwifery are in accordance with standardized procedures or protocols, as defined; or a patient-specific protocol approved by a physician and surgeon, as specified. (BPC §2746.51(a))
- Makes the furnishing or ordering of drugs or devices by a CNM conditional on the issuance of a furnishing number by the BRN, as specified, and requires every CNM issued a BRN furnishing number to register with the United States Drug Enforcement Administration and the Controlled Substance Utilization Review and Enforcement System. (BPC § 2746.51(b)(1))
- Permits a CNM to perform and repair episiotomies, and to repair first-degree and second-degree lacerations of the perineum and must ensure that all complications are referred to a physician and surgeon and the immediate care of patients who are in need of care beyond the scope of practice of the CNM, or emergency care for times when a physician and surgeon is not on the premises. (BPC § 2746.52)
- Requires the collection of specified data, within 90 days, for all maternal or neonatal transfers to the hospital setting during the labor or the immediate postpartum period, for which the intended place of birth was an out-patient hospital setting at the onset of labor, or for any maternal, fetal, or neonatal death that occurred in the out-of-hospital setting during labor or the immediate postpartum period and for which the intended birth care provider is a CNM in the out-of-hospital. (BPC § 2746.55)
- Provides for the licensure, registration, and regulation of clinical laboratories and various clinical laboratory personnel by CDPH, with specified exceptions. (Business and Professions Code (BPC) § 1200-1327)
- Defines, for purposes of state regulation of clinical laboratories, the following:
- “CLIA” to mean the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a; P.L. 100-578) and the regulations adopted thereunder by the federal Health Care Financing Administration and effective on January 1, 1994, or any later date, when adopted in California pursuant to subdivision (b) of Section 1208. (BPC § 1202.5(a))
- “Clinical laboratory” to mean 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. (BPC § 1206(a)(8))
- Prohibits a person from performing 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 specified personnel. (BPC § 1206.5(a))
- States that 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, where the test is performed by one of the following:
- a licensed physician and surgeon holding an M.D. or D.O. degree;
- a licensed podiatrist or a licensed dentist, as specified;
- a person licensed to engage in clinical laboratory practice or to direct a clinical laboratory, as specified;
- a person who supports a public health laboratory in the examination of specimens from suspected cases of infections and environmental diseases, that may include milk products, waters, and the environment, as specified;
- a licensed physician assistant, as specified;
- a perfusionist, as specified;
- a respiratory care practitioner, as specified;
- a person performing nuclear medicine technology, as specified;
- a person if performing blood gas analysis, as specified;
- 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 a podiatrist who will: 1) ensure that the person is performing test methods as required for accurate and reliable tests; and 2) 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. (BPC § 1206.5(c) and Health and Safety Code (HSC) § 101150)
- Defines a “practitioner” for purposes of a claimant establishing medical eligibility for filing a claim for disability benefits supported by the certificate of a treating physician or practitioner. (Unemployment Insurance Code § 2708(a)(1) and 2708(e)(2).
Existing Federal Law:
- Establishes CLIA under federal law, which regulates clinical laboratories that perform tests on human specimens and sets standards for facility administration, personnel qualifications and quality control. These standards apply to all settings, including commercial, hospital or physician office laboratories. (Code of Federal Regulations (CFR) Title 42 § 493)
- Defines CLIA waived tests as simple laboratory examinations and procedures that are approved by the Food and Drug Administration (FDA) for home use, employ methodologies that are simple and accurate as to render the likelihood of erroneous results negligible or pose no reasonable risk of harm to the patient if the test is performed incorrectly. (CFR Title 42 § 493)
This bill:
- Authorizes an alternative birth center or primary care clinic to 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 DPH complies with specified provisions, and the following requirements are specified:
- If performing tests classified as waived, the alternative birth center or primary care clinic must do both the following:
- The alternative birth center or primary care clinic obtains a valid CLIA certificate of waiver and complies with all other testing requirements for the performance of waived clinical laboratory tests under applicable federal regulations;
- For purposes of CLIA, the person identified as responsible for directing and supervising testing oversight and decision-making to be a CNM, a licensed midwife or a physician and surgeon.
- If performing a provider-performed microscopy, the alternative birth center or primary care clinic do both of the following:
- The alternative birth center or primary care clinic obtains a valid CLIA certificate for provider-performed microscopy and complies with specified requirements;
- For purposes of CLIA, the person identified as responsible for directing and supervising testing oversight and decision-making must be a CNM or a physician and surgeon, as specified.
- Defines for the purposes of 1) above:
- “Alternative birth center” to mean means a clinic that is not part of a hospital and that provides comprehensive perinatal services and delivery care to pregnant women who remain less than 24 hours at the facility, as currently defined in HSC 1204).
- “Primary care clinic” to mean a primary care clinic as defined in the HSC § 1204, that is established as a clinic or office for one or more CNMs or licensed midwives, as specified.
- Specifies that in the case of an alternative birth center that applies for registration from the DPH to perform specified waived tests, “laboratory director” means the person identified as the responsible party for directing and supervising testing oversight for the purpose of obtaining a CLIA certificate, as permitted by this bill.
- Adds common gynecologic conditions to the practice of midwifery by a CNM.
- Permits a CNM who holds privileges in a general acute care hospital, as defined, to admit and discharge patients upon their own authority, within their scope of practice and in accordance with the bylaws of that facility, as specified.
- Updates and revises the authority for CNMs to furnish and order controlled substances classified in schedule II, III, IV, and V,
- Deletes the requirement that a copy of standardized procedure or protocol relating to the furnishing or ordering of controlled substances by a CNM be provided upon request to any licensed pharmacist who is uncertain of the CNM to perform these functions.
- Clarifies that a CNM may dispense drugs, which are defined in the pharmacy law as not dangerous, as specified.
- Adds a CNM to the definition of “prescriber” in the pharmacy law, as specified.
- Adds low-risk pregnancy and childbirth or postpartum conditions consistent with the scope of a CNM’s or midwife’s professional license to the definition of “practitioner” for purposes of obtaining medical eligibility for disability, as specified.
- Makes other technical and clarifying changes.
FISCAL EFFECT:
Unknown. This bill is keyed fiscal by Legislative Counsel.
COMMENTS:
- Purpose. The California Nurse Midwives Association is the sponsor of this bill. According to the author, “After SB 1237 was passed in 2020, nurse-midwives across the state have noted various barriers to nurse-midwifery care, despite the intention of SB 1237 to solve these issues and allow for nurse-midwifery expansion and sustainability, especially in low-resource areas where the nurse-midwife is one of few providers, in community birth practice settings (such as freestanding birth centers), and where nurse-midwives care for patients with Medi-Cal. The various issues are noted in question #2 above and typically involve delays in patient care and treatment, and the ability of independent nurse-midwifery practices to exist, simply due to unnecessary administrative barriers or supervisory requirements that SB 1237 aimed to solve.”
- Background.
The practice of midwifery. In California, there are two distinct providers of care for those who attend to cases of low-risk pregnancy and childbirth, licensed midwives (LMs) and CNMs. LMs are authorized to attend cases of normal pregnancy and childbirth and to provide prenatal, intrapartum, and postpartum care, including family-planning care, for the mother and immediate care for the newborn. LMs can also directly obtain supplies and devices, obtain and administer drugs and diagnostic tests, order testing and receive reports that are necessary to his or her practice of midwifery and consistent with his or her scope of practice. LMs can practice in a home, birthing clinic or hospital environment. LMs are licensed by the Medical Board of California.
CNM are advanced practice registered nurses who have specialized education and training to provide primary care, prenatal, intrapartum, and postpartum care, including interconception care and family planning. These individuals are licensed by the BRN, have acquired additional training in the field of obstetrics, and are certified by the American College of Nurse Midwives. In order to obtain a certificate to practice as a CNM, the applicant must provide proof to the BRN that they have either graduated from a BRN approved program in nurse-midwifery or satisfied equivalence standards as set forth in the BRN’s regulations (Title 16 California Code of Regulations § 1460).
The nurse-midwifery certificate authorizes the CNM to attend cases of low-risk pregnancy and childbirth, as well as immediate care for the newborn along with family planning and interconception care. CNMs are permitted to furnish or order drugs and devices in certain healthcare settings, as permitted in the certificate to practice midwifery in California. If a CNM orders or furnishes a drug or device that would be outside of the standard of care authorized by the certificate to practice midwifery, the CNM may only do so if they have established mutually agreed upon protocols with a physician and surgeon. Additionally, in order to furnish drugs or devices, the CNM must obtain a furnishing number from the BRN, and register with the United States Drug Enforcement Administration and the Controlled Substance Utilization Review and Enforcement System.
In 2020, the Legislative Analyst’s Office conducted a study titled Analysis of California’s Physician-Supervision Requirement for Certified Nurse Midwives[1]. The study was conducted in response to a Legislator request, and analyzed the impact of the prior physician-supervision requirement for CNMs on health care outcomes and access to care for mothers and their infants. Ultimately, the report concluded, “The state’s physician‑supervision requirement for nurse midwives is intended to improve the safety and quality of women’s health care. Following our review of academic literature on the safety and quality of care by nurse midwives, however, we do not find sufficient evidence to justify this occupational restriction for two reasons. First, we do not find evidence that the safety and quality of maternal and infant health care by nurse midwives is inferior to that of physicians. Second, states with physician‑supervision or very similar requirements do not have superior maternal and infant health outcomes. Consequently, the supervision requirement for nurse midwives does not appear to positively affect safety and quality.”
The report did provide recommendations to ensure the appropriate care and safeguards for recipients of services including: maintaining referral and consultative relationships with physicians and other providers, practice as part of a health system, practice in an accredited facility, maintain medical malpractice, and meet clinical experience standards. As the report noted, the data for outcomes in birth centers was not as robust and drawing conclusions about services provided in those facilities are not as definitive.
SB 1237 and CNM Independent Practice Authorization. Prior to 2020, CNMs were required to practice under the supervision of a physician and surgeon under standardized procedures and protocols. Standardized procedures were developed collaboratively by nurses, physicians, and the administration of the organized health care system. The BRN and the Medical Board of California jointly promulgated guidelines for standardized procedures (CCR, tit. 16, § 1474), based on the competence of the nurses providing the procedures and include record, referral, and setting requirements, among other patient protections. While supervision by a physician was required for CNMs to provide patient care, that supervision did not require the physical presence of a physician and physicians are limited to supervising no more than 4 CNMs at a time. Meaning, a CNM would work miles away from the actual location of the physician, and as long as the standardized procedures are in place, the CNM would deliver babies and provide other authorized practices by a CNM.
SB 1237 (Dodd, Chapter, Statutes of 2019) revised the current practice authorization for CNMs. That bill eliminated the requirement for a CNM to practice midwifery according to standardized procedures or protocols with a physician in an effort to allow CNMs to practice independently of physician supervision.
That bill revised provisions defining the practice of midwifery, authorized a CNM to attend cases of childbirth outside of a define hospital setting; authorizes a CNM to furnish or order drugs or devices in accordance with standardized protocols with a physician; requires a CNM to provide specified disclosures to a patient; and, establishes new reporting and data collection requirements. SB 1237 did not change the scope of work that a CMN could perform, but permitted a CNM to perform their work without physician supervision. For example, prior to SB 1237, a CNM could only provide services under a standardized procedure and protocol established with a licensed physician and surgeon.
Current law, BPC §2746.5 permits a CNM to furnish order or furnish a drug or device that falls within the standard of care, as permitted in the certificate to practice midwifery without mutually agreed upon protocols. However, if the CNM seeks to order or furnish a drug or device that would fall outside of that services authorized in a certificate to practice midwifery, or if it is a controlled substance Schedule, they can only do so under mutually agreed upon protocols of a physician.
It appears that after three years of implementation of independent practice for CNMs, there are aspects of current law that hinder the CNM’s ability to fully practice independently as was the aim of SB 1237. This bill attempts to address these challenges by updating and revising a number of provisions related to the CNM’s practice authority. One of the more significant updates is the revisions to the CNM’s prescribing authority. As a result of SB 1237, CNMs were limited in prescribing certain controlled substances unless they had established mutually agreed upon protocols with a physician and surgeon. This bill revises that requirement and would permit a CNM to furnish or order a drug or device that is schedule II or III, as long as furnishing or prescribing that drug would fall within the standard of care of a CNM’s certificate to practice midwifery-if the prescribing would fall outside of those parameters, the CNM would be required to have a mutually agreed upon protocols.
This bill adds CNMs to the definition of “practitioner” under the unemployment insurance code to ensure that CNMs can establish eligibility for disability purposes related to low-risk pregnancy, childbirth and postpartum conditions. This bill would also add the care of “common gynecological conditions” to the list of services that a CNM is able to provide based on a certificate to practice midwifery. If a CNM were to provide care for a gynecological condition that falls outside that normal parameter, they would subject themselves to potential enforcement by the BRN. This bill updates the pharmacy law to include CNMs in the definition of “prescriber”, among other provisions.
As part of AB 1237, the bill required established various reporting and data collection requirements related to labor and deliver services occurring in an out-of-hospital setting. Although a report of that data is currently underway, past data on the number of CNMs providing care is relevant. As report, in 2017, CNMs were recorded as attending almost 50,000 births in the state, or somewhat more than 10 percent of the 470,000 births in the state that year. Of that number approximately 781 provided births in birth centers.
Federal and State Regulation for Clinical Laboratory Testing. A facility that performs laboratory tests on human specimens for diagnosis or assessment must be certified under CLIA. CLIA certification requirements vary depending on the complexity of the laboratory tests performed.
Clinical laboratories or other testing sites need to know whether each test system used is waived, moderate, or high complexity. In general, the more complicated the test, the more stringent the requirements, including increased training and licensing of laboratory personnel. At a minimum, all laboratories must have a licensed clinical laboratory director. The FDA determines the complexity of CLIA laboratory tests. Waived tests are simple tests with a low risk for an incorrect result. They include tests listed in the CLIA regulations, tests cleared by the FDA for home use, and tests approved for waiver by the FDA using the CLIA criteria. Tests not classified as waived are assigned a moderate or high complexity category based on seven criteria given in the CLIA regulations, including ease of use, knowledge required, and types of materials tested. For commercially available FDA-cleared or approved tests, the test complexity is determined by the FDA during the pre-market approval process. While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements.
While CLIA establishes minimum federal standards, it allows states to enact more stringent state law requirements. At the federal level and in California, anyone may perform a waived test in a licensed laboratory or as part of a nondiagnostic health assessment program under the overall direction of a laboratory director, unless otherwise limited. In applying for a CLIA certificate of waiver, the laboratory director must list the types of analytes to be tested, the tests performed, and the test manufacturer.
Currently, CNMs who work independently at certain facilities including alternative birth centers, where there is not a physician and surgeon owner, and therefore no licensed laboratory director, report that they are unable to provide routine, standard tests unless they contract with a physician and surgeon who is willing to lend their license to the facility simply for oversight purposes. This can be costly for the CNM
As specified in BPC § 2746.51(f), A CNM may directly procure supplies and devices, obtain and administer diagnostic tests, directly obtain and administer nonscheduled drugs consistent with the provision of services that fall within the scope of services, as specified, order laboratory and diagnostic testing, and receive reports that are necessary to their practice as a certified nurse-midwife within their scope of practice as specified within the certificate to practice midwifery. However, the author and sponsor note difficulties in administering tests.
As noted by the author, “This bill reduces costly barriers to birth center sustainability and practice start-ups, by allowing certified nurse-midwives to perform specific tests within their birth center or independent midwifery practice, consistent with federal CLIA laboratory rules. California still requires physician laboratory directors for birth centers and midwife-led/midwife-owned practices. This is costly for midwifery practices, unsustainable, and misaligned with federal rules.” To remedy the concern that CNMs practicing within these facilities are not able to provide the necessary care and tests for clients, this bill seeks to establish a registration component for alternative birth centers and clinics.
- Arguments in Support. The California Nurse-Midwives Association writes in support, “This bill clarifies and expands upon several other aspects of CNM practice. It advances the integration and sustainability of midwifery care by clarifying that a CNM does not have to “be in the same practice with” a physician to collaborate and consult with that physician. The bill works to enhance continuity of care and improved safety for the patient by allowing hospitals, should they wish to do so, the ability to grant admitting and discharge privileges to CNMs. It also streamlines the current requirement to have both a “standardized procedure” and “mutually agreed upon policies and protocols” into one mandatory document. As mentioned above, it reduces unnecessary appointments and improves person-centered care by making temporary disability certification by CNMs consistent with the CNM scope of practice. This bill also strengthens continuity and access by clarifying the ability of CNMs to dispense drugs that are consistent with their scope of practice and current prescribing capabilities. It also reduces costly barriers that threaten the sustainability of birth centers and midwife-owned clinics by exempting these specific clinics from California rules that require a physician to be the laboratory director. This bill seeks to reduce geographic and economic barriers to reproductive health care by extending the ability of CNMs to manage common gynecologic conditions across the lifespan rather than only within the discrete periods of pregnancy and conception.”
Maternal Mental Health American Association of Birth Centers, American Nurses Association\ California, Best Start Birth Center, NARAL Pro-Choice California, National Health Law Program Purchaser Business Group on Health California Association of Nurse Anesthetists, San Francisco Black & Jewish Unity Coalition, and Training in Early Abortion for Comprehensive Healthcare write in support and notes, “SB 667 addresses the redundancies, and red tape revealed only through the everyday practice of midwives who continue to experience disruptive and unnecessary limitations to practice.”
California Association of Nurse Practitioners writes in support and notes, “In 2020, the Legislature passed SB 1237 (Dodd), which allowed for CNMs to practice independently of physicians for “normal,” low-risk pregnancies, as well as collaborate with physicians in caring for patients with more complex needs. SB 667 will further the goal of SB 1237. While SB 1237 was intended to address limitations to CNMs’ practice, in working to implement the bill, CNMs have discovered additional disruptive, unnecessary, and redundant limitations that ultimately disrupt and delay patients’ care. SB 667 will rectify these issues so that these highly qualified providers may practice to full extent of their training as SB 1237 intended.”
- Arguments in Opposition. The American College of Obstetricians and Gynecologists District IX writes in opposition and notes, “SB 667 would authorize nurse midwives to furnish any controlled substance, including narcotics, without mutually agreed upon policies and protocols with a physician. When SB 1237 was negotiated and nurse midwives were granted independence for low-risk pregnancies, both parties agreed nurse midwives would only furnish these drugs in collaboration with a physician. This resolution was an important element of SB 1237 that allowed ACOG to go neutral; an issue that remains important today. While physicians are working to reduce the utilization of narcotics in obstetric care, SB 667 goes the opposite direction by authorizing nurse-midwives who treat low risk conditions to use high risk, addictive drugs. Given the present scope of nurse-midwives, ACOG does not understand the utility of a blanket authorization and in those rare cases where a scheduled drug may be necessary, the procedure may very well be moving to high risk and per existing law (as establish in SB 1237), mutually agreed upon policies and protocols with a physician are warranted… while we appreciate and understand the nurse midwives desire to perform certain tests without needing a laboratory director, authorizing nurse-midwives to become laboratory directors, solely for that purpose, is problematic. ACOG is willing to discuss other options to address their issues involving certain tests but cannot support allowing nurse-midwives to be laboratory directors.”
The California Academy of Family Physicians writes in support, “SB 667 would authorize nurse midwives to furnish any controlled substance, including narcotics, without mutually agreed upon policies and protocols with a physician. While physicians are working to reduce the utilization of narcotics in obstetric care, SB 667 goes in the wrong direction by authorizing nurse-midwives who treat low risk conditions to use high risk, addictive drugs. Given the present scope of nurse-midwives, it is unclear the utility of a blanket authorization and in those rare cases where a scheduled drug may be necessary, the procedure may very well be moved to high risk and per existing law, mutually agreed upon policies and protocols with a physician are warranted.”
The California Medical Association writes in opposition and notes, “SB 667 would also authorize nurse midwives to be identified as laboratory directors. CMA understands the reason for this provision is to allow nurse midwives to perform specific CLIA waived tests within their scope without having supervision by a laboratory director. Laboratory directors remain ultimately responsible and must ensure that all the duties are properly performed and applicable CLIA regulations are met, ensuring the laboratory develops and uses a quality system approach to laboratory testing that provides accurate and reliable patient test results. While we appreciate and understand the nurse-midwives desire to perform certain tests without needing a laboratory director, authorizing nurse-midwives to become laboratory directors, solely for that purpose, is problematic. CMA is willing to discuss other options to address their issues involving certain tests but cannot support allowing nurse-midwives to be laboratory directors.”
- Policy Issues for Consideration and Suggested Amendment. As currently, drafted, this bill seeks to address the issue that CNMs who may own or practice at a birth center are not able to order and perform certain tests. Under current law, only designated providers may be a licensed clinical laboratory director, and only designated healthcare providers may perform certain waived and moderate complexity tests under the licensed clinical laboratory director. When CNMs were provided independent practice authority in SB 1237, this issue was not contemplated. Because CNMs are not licensed clinical laboratory directors as required under existing law, they are currently unable to conduct, what they consider routine tests in a birth center if they are unable contract with a physician and surgeon who lends their license as the laboratory director in order for the CNM to provide certain CLIA-waived and specified moderate-complexity tests that are applicable under the CNM’s authority under their certificate to practice.
In order to address this issue to providing care, this bill would establish a new registration program under the CDPH, for purposes of obtaining laboratory authority. Specifically, this bill would authorize an alternative birth center or primary care clinic, as defined, to perform testing and examinations classified as waived or a provider-performed microscopy consistent with services within the scope of the CNM’s license, if specified requirements were satisfied.
However, the authority to function as a laboratory director is provided to persons, not to facilities as this bill proposes, creating a lack of clarity and implementation issues. The more appropriate way to address this need for independently practicing CNMs to continue to safely serve their patients is to specifically authorize a CNM to become a laboratory director for purposes of conducting CLIA-waived tests or a provider-performed microscopy, consistent with the practice of CNMs, as referenced under the certificate to practice authority. CNMs are currently permitted to perform specified CLIA-waived tests under existing law, but only under the supervision of a physician and surgeon under the licensed clinical laboratory director. As such, the bill should be amended according to the following:
Amend BPC Section 1209 as follows:
(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 otherwise provided in subparagraph (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 nurse- midwife holding a certificate as specified by Section 2746.5 serving as the director of a laboratory that only performs clinical laboratory tests, inclusive of provider performed microscopy, authorized within the scope of the certificate to practice midwifery as specified in 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
SUPPORT AND OPPOSITION:
Support:
2020 Mom
American Association of Birth Centers
American Nurses Association/California
Best Start Birth Center
California Association for Nurse Practitioners
California Association of Nurse Anesthetists
California Nurse Midwives Association
NARAL Pro-choice California
National Health Law Program
Purchaser Business Group on Health
San Francisco Black, Jewish and Unity Group
Training in Early Abortion for Comprehensive Health Care
Opposition:
American College of Obstetricians and Gynecologists District IX
California Academy of Family Physicians
California Medical Association
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https://lao.ca.gov/Publications/Report/4197#Recommendations ↑
Discussed in Hearing
37SEC
Senate Floor
1MIN
Assembly Floor
32SEC
Assembly Floor
7MIN
Assembly Standing Committee on Business and Professions
1MIN
Senate Floor
16MIN
Senate Standing Committee on Business, Professions and Economic Development
Bill Author
Bill Co-Author(s):
