BILL ANALYSIS
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|SENATE RULES COMMITTEE | SB 1246|
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UNFINISHED BUSINESS
Bill No: SB 1246
Author: Negrete McLeod (D)
Amended: 8/2/10
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 8-0,
4/12/10
AYES: Negrete McLeod, Wyland, Aanestad, Calderon, Correa,
Oropeza, Walters, Yee
NO VOTE RECORDED: Florez
SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8
SENATE FLOOR : 28-0, 5/28/10
AYES: Alquist, Ashburn, Calderon, Cedillo, Corbett,
Correa, DeSaulnier, Ducheny, Dutton, Florez,
Hollingsworth, Huff, Kehoe, Leno, Liu, Lowenthal, Negrete
McLeod, Padilla, Pavley, Price, Romero, Runner, Simitian,
Steinberg, Strickland, Wolk, Wyland, Yee
NO VOTE RECORDED: Aanestad, Cogdill, Cox, Denham, Hancock,
Harman, Oropeza, Walters, Wiggins, Wright, Vacancy,
Vacancy
ASSEMBLY FLOOR : 78-0, 8/12/10 (Consent) - See last page
for vote
SUBJECT : Naturopathic medicine
SOURCE : California Naturopathic Doctors Association
CONTINUED
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DIGEST : This bill includes naturopathic doctors in the
list of health care practitioners who could perform a
clinical laboratory test or examination classified as
waived and defines a naturopathic assistant for purposes of
the Naturopathic Doctors Act, and specifies certain
functions for naturopathic assistants.
Assembly Amendments make technical changes to the duties a
naturopathic assistant may perform.
ANALYSIS :
Existing law:
1. Establishes the Naturopathic Doctors Act, administered
by the Naturopathic Medicine Committee (Committee)
within the Osteopathic Medical Board of California to
regulate the practice of naturopathic medicine. Sunsets
the provisions of the Naturopathic Doctors Act on
January 1, 2013.
2. Defines naturopathic medicine as a distinct and
comprehensive system of primary health care practiced by
a naturopathic doctor for the diagnosis, treatment, and
prevention of human health conditions, injuries, and
disease.
3. Establishes in federal law, the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), which regulates
laboratories when performing testing on human specimens,
and includes laboratory standards for proficiency
testing, facility administration, personnel
qualifications, and quality control. Applies standards
to all settings, including commercial, hospital, or
physician office laboratories.
4. Defines under CLIA waived tests as simple laboratory
examinations and procedures that are cleared by the Food
and Drug Administration (FDA) for home use; employ
methodologies that are so 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.
5. Establishes within the Department of Public Health (DPH)
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the Laboratory Field Services which provides for
licensing and registration services for clinical
laboratories, as specified.
6. Requires a clinical laboratory that performs tests that
are of moderate or high complexity to be licensed by
DPH. Requires a clinical laboratory that performs tests
that are of low complexity, also referred to as "waived
tests," or that perform provider-performed microscopy,
which is microscopic analysis of a specimen by a health
care provider such as a physician, to be registered,
rather than licensed, by DPH.
7. Defines a clinical laboratory as any establishment or
institution operated for the performance of clinical
laboratory tests or examinations, or the practical
application of clinical laboratory sciences. Requires
clinical laboratories to pay fees, as specified, to DPH
for the purposes of initial and renewal licensure,
registration, or certification.
8. Prohibits anyone 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, and the test is performed by
specified persons, including physicians and surgeons,
podiatrists, dentists, physician assistant, or
respiratory care practitioner.
This bill:
1. Includes a licensed naturopathic doctor in the list of
persons who could perform a clinical laboratory test or
examination classified as waived under CLIA.
2. Includes a naturopathic assistant, as defined, to the
list of persons who could perform a clinical laboratory
test or examination classified as of moderate complexity
if the waived test is performed to a specific
authorization meeting specified requirements.
3. Includes in the definition of laboratory director a duly
licensed naturopathic doctor for the purposes of a
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clinical laboratory test or examination classified as
waived.
4. Defines a naturopathic assistant as a person who may be
unlicensed, who performs basic administrative, clerical,
and technical supportive services, in compliance with
this bill, for a licensed naturopathic doctor or
naturopathic corporation and who is at least 18 years of
age, and who has had at least the minimum amount of
hours of appropriate training pursuant to standards
established by the MBC for a medical assistant, as
specified. Requires the naturopathic assistant to be
issued a certificate by the training institution or
instructor indicating satisfactory completion of the
required training. Requires a copy of the certificate
to be retained as a record by each employer or the
naturopathic assistant.
5. Defines naturopathic technical supportive services as
simple routine medical tasks and procedures that may be
safely performed by a naturopathic assistant who has
limited training and who functions under the supervision
of a licensed naturopathic doctor.
6. Defines specific authorization as specific written order
prepared by the supervising naturopathic doctor
authorizing the procedures to be performed on a patient,
which shall be placed in the patient's medical record,
or a standing order prepared by the supervising
naturopathic doctor authorizing the procedures to be
performed. Requires a notation of the standing order
shall be placed on the patient's medical record.
7. Defines supervision of a naturopathic assistant as the
supervision of procedures authorized by a naturopathic
doctor, within his/her scope of practice, as specified,
and who is physically present in the treatment facility
during the performance of those procedures.
8. Authorizes a naturopathic assistant to do all of the
following:
A. Administer medication only by intradermal,
subcutaneous, or intramuscular injections and perform
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skin tests and additional technical support services
upon the specific authorization and supervision of a
licensed naturopathic doctor. Authorizes a
naturopathic assistant to also perform these services
at licensed clinics, as specified.
B. Perform venipuncture or skin puncture for the
purposes of withdrawing blood upon specific
authorization and under the supervision of a licensed
naturopathic doctor after meeting existing
educational and training requirements for medical
assistants, as specified. Requires a copy of any
related certificates shall be retained as a record by
each employer of the assistant.
9. Authorizes a naturopathic assistant to perform the
following naturopathic technical support services:
A. Administer medications, as specified. Requires
that in every instance, prior to administration of
medication by the naturopathic assistant, the
naturopathic doctor shall verify the correct
medication and dosage.
B. Apply and remove bandages.
C. Collect by noninvasive techniques and preserve
specimens for testing, including urine, sputum,
semen, and stool.
D. Assist patients to and from patient examination
room or examination table.
E. As authorized by the naturopathic doctor, provide
patient information and instructions.
F. Collect and record patient data, including height,
weight, temperature, pulse, respiration rate, and
blood pressure, and basic information about the
presenting and previous conditions.
G. Perform simple laboratory and screening tests
customarily performed in a medical office.
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H. Perform additional naturopathic technical support
services under regulations and standards established
by the Committee. Requires the Committee, prior to
adopting any regulations request recommendations from
other public agencies, and professional associations.
10.States that nothing in this bill shall be construed to
do the following:
A. Authorize the licensure of naturopathic
assistants.
B. Authorize the administration of local anesthetic
agents by a naturopathic assistant.
C. Authorize the Naturopathic Medicine Committee to
adopt any regulations that violate the prohibition on
diagnosis or treatment, as specified.
11.States that a naturopathic assistant may not be employed
for inpatient care in a licensed general acute care
hospital.
Background
Scope of Practice, Education and Training Requirements of
Naturopathic Doctors . SB 907 (Burton), Chapter 485,
Statutes of 2003, established until July 1, 2009, the
Naturopathic Doctor Act (Act), to be administered by the
Bureau of Naturopathic Medicine within the Department of
Consumer Affairs to establish standards for licensure and
regulation of naturopathic medicine. AB 20 X4
(Strickland), Chapter 18, Statutes of 2009-10, Fourth
Extraordinary Session, abolished the Bureau of Naturopathic
Medicine and created the Naturopathic Medicine Committee
within the Osteopathic MBC and extended the sunset date of
the Act to January 1, 2013.
Under the Act, naturopathic doctors may order and perform
physical and laboratory examinations for diagnostic
purposes, including, but not limited to phlebotomy,
clinical laboratory tests, and speculum examinations. A
naturopathic doctor may also order diagnostic imaging
studies, dispense, administer, order, and prescribe or
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perform the following: food, extracts of food,
nutraceuticals, botanical medicines, homeopathic medicines,
all dietary supplements, and non-prescription drugs, as
specified; hot or cold hydrotherapy and other physical
medicine; devices; health education and health counseling;
repair and care incidental to superficial lacerations and
abrasions; and removal of foreign bodies located in the
superficial tissues. The Act also authorizes a
naturopathic doctor to furnish or order drugs when the
drugs are ordered in accordance with standardized
procedures or protocols developed by the naturopathic
doctor and his/her supervising physician; the naturopathic
doctor is functioning pursuant to standardized procedures
and protocols, as specified; the standardized procedure or
protocol specify among other things which naturopathic
doctor may furnish the drug, which drugs may be furnished;
and the furnishing or ordering of drugs occurs under
physician and surgeon supervision. The Act also specifies
that a physician and surgeon shall not supervise more than
four naturopathic doctors at one time.
The Act requires the Committee to approve a naturopathic
medical education program that has the following minimum
requirements: (1) Admission requirements that include a
minimum of three-quarters of the credit required for a
bachelor's degree, as specified, and (2) a minimum of 4,100
total hours in basic and clinical sciences, naturopathic
philosophy, naturopathic modalities, and naturopathic
medicine. Not less than 2,500 hours shall consist of
academic instruction, and not less than 1,200 hours of
supervised clinical training approved by the naturopathic
medical school.
FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes
Local: No
SUPPORT : (Verified 8/10/10)
California Naturopathic Doctors Association (source)
Osteopathic Physicians & Surgeons of California
ARGUMENTS IN SUPPORT : The bill's sponsor, the California
Naturopathic Doctors Association, states that a
naturopathic doctor's inability to perform CLIA waived
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tests compromises patient safety by delaying tests and
their results. This bill would designate naturopathic
doctors as laboratory directors for CLIA waived tests only.
The sponsor points out that naturopathic doctors in other
states are able to perform CLIA waived and moderate
complexity tests. Additionally, this bill includes
provisions allowing a naturopathic doctor to supervise an
assistant which will provide more time for naturopathic
doctors to see patients and run a more efficient practice.
Currently, private practice naturopathic doctors must
perform all simple patient related tasks, such as vitals,
taking blood and giving shots.
ASSEMBLY FLOOR :
AYES: Adams, Ammiano, Anderson, Arambula, Bass, Beall,
Bill Berryhill, Tom Berryhill, Blakeslee, Block,
Blumenfield, Bradford, Brownley, Buchanan, Caballero,
Charles Calderon, Carter, Chesbro, Conway, Cook, Coto,
Davis, De La Torre, De Leon, DeVore, Eng, Evans, Feuer,
Fletcher, Fong, Fuentes, Fuller, Furutani, Gaines,
Galgiani, Garrick, Gatto, Gilmore, Hagman, Hall, Harkey,
Hayashi, Hernandez, Hill, Huber, Huffman, Jeffries,
Jones, Knight, Lieu, Logue, Bonnie Lowenthal, Ma,
Mendoza, Miller, Monning, Nava, Nestande, Niello,
Nielsen, V. Manuel Perez, Portantino, Ruskin, Salas,
Saldana, Silva, Skinner, Smyth, Solorio, Audra
Strickland, Swanson, Torlakson, Torres, Torrico, Tran,
Villines, Yamada, John A. Perez
NO VOTE RECORDED: Norby, Vacancy
JJA:mw 8/16/10 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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