BILL ANALYSIS
SB 1246
Page 1
Date of Hearing: June 22, 2010
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 1246 (Negrete McLeod) - As Amended: June 15, 2010
SENATE VOTE : 28-0
SUBJECT : Naturopathic medicine.
SUMMARY : Permits naturopathic doctors (NDs) to perform waived
Clinical Laboratory Improvement Amendments (CLIA) tests, sets
parameters for naturopathic assistant (NA) employment, and
authorizes the Naturopathic Medicine Committee (committee) to
adopt regulations relating to NAs. Specifically, this bill :
1)Permits NDs and NAs, as specified, to perform a clinical
laboratory test or examination classified as waived under
CLIA.
2)Includes NDs in the definition of "laboratory director" for
purposes of clinical laboratory tests or examinations
classified as waived.
3)Permits NAs to do the following:
a) Administer medication only by intradermal, subcutaneous,
or intramuscular injections and perform skin tests and
additional technical support services upon the specific
authorization and supervision of a ND. An NA may also
perform all these tasks and services in a clinic upon the
specific authorization of a ND.
b) Perform venipuncture or skin puncture for the purposes
of withdrawing blood upon specific authorization and under
the supervision of a ND if prior thereto the NA has met the
educational and training requirements for medical
assistants, as specified. A copy of any related
certificates shall be retained as a record by each employer
of the NA.
c) Perform the following naturopathic technical support
services:
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i) Administer medications orally, sublingually,
topically, vaginally, or rectally, or by providing a
single dose to a patient for immediate
self-administration. Administer medication by inhalation
if the medications are patient-specific and have been or
will be repetitively administered to the patient. In
every instance, prior to administration of medication by
the NA, the ND shall verify the correct medication and
dosage;
ii) Apply and remove bandages;
iii) Collect by noninvasive techniques and preserve
specimens for testing, including urine, sputum, semen,
and stool;
iv) Assist patients to and from a patient exam room or
exam table;
v) As authorized by the ND, provide patient information
and instructions;
vi) Collect and record patient data, including height,
weight, temperature, pulse, respiration rate, blood
pressure, and basic information about the presenting and
previous conditions; and,
vii) Perform simple laboratory and screening tests
customarily performed in a medical office.
d) Perform additional naturopathic technical support
services under the regulations and standards established by
the committee.
4)Requires the committee to, prior to the adoption of any
regulations related to NAs, request recommendations regarding
standards from appropriate public agencies, including, but not
limited to, the Medical Board of California (MBC), the Board
of Registered Nursing, the Board of Vocational Nursing and
Psychiatric Technicians of the State of California, the
Laboratory Field Services division of the State Department of
Public Health, and the Physical Therapy Examining Committee.
The committee shall also request recommendations regarding
these standards from associations of medical assistants (MAs),
physicians, and others, as appropriate, including, but not
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limited to, the California Medical Association, the California
Society of Medical Assistants, and the California Medical
Assistants' Association.
5)States that nothing in this bill shall be construed as
authorizing:
a) The licensure of NAs;
b) NAs to administer local anesthetic agents;
c) The committee to adopt any regulations that violate the
prohibitions on diagnosis or treatment, as specified; or
d) NAs to perform any clinical laboratory test or
examination for which he or she is not authorized.
6)Prohibits an NA from employment in a licensed general acute
care hospital for inpatient care.
7)Defines the following:
a) "NA" means a person who may be unlicensed, who performs
basic administrative, clerical, and technical supportive
services, as specified, for a licensed ND or naturopathic
corporation, 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 MBC for a MA.
A NA shall be issued a certificate by the training
institution or instructor indicating satisfactory
completion of the required training. A copy of the
certificate shall be retained as a record by each employer
or the NA;
b) "Naturopathic technical supportive services" means
simple routine medical tasks and procedures that may be
safely performed by a NA who has limited training and who
functions under the supervision of a licensed ND;
c) "Specific authorization" means a specific written order
prepared by the supervising ND 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 ND authorizing the procedures to be
performed. A notation of the standing order shall be
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placed on the patient's medical record; and,
d) "Supervision" means the supervision of procedures
authorized, as specified, by a ND within his or her scope
of practice, who is physically present in the treatment
facility during the performance of those procedures.
EXISTING LAW :
1)Establishes the Naturopathic Doctors Act (Act),
administered by the committee within the Osteopathic
Medical Board of California (OMBC) to regulate the
practice of naturopathic medicine.
2)Defines naturopathic medicine as a distinct and
comprehensive system of primary health care practiced by
a ND for the diagnosis, treatment, and prevention of
human health conditions, injuries, and disease.
3)Establishes 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)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 assistants, or
respiratory care practitioners.
5)Defines a MA as a person who may be unlicensed, who
performs basic administrative, clerical and technical
supportive services for a licensed physician and surgeon
or a licensed podiatrist, physician assistants, nurse
practitioners, nurse-midwives or for a health care
service plan, who is at least 18 years of age, and who
has had at least the minimum amount of hours of training
as specified. Defines technical supportive services as
simple routine medical tasks and procedures that may be
safely performed by MAs who have limited training and who
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function under supervision.
6)Authorizes MAs to perform specified services relating to
administration of medication and performance of skin
tests and simple routine medical tasks and procedures
upon specific authorization from and under the
supervision of a licensed physician and surgeon or
podiatrist.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of this bill . According to the author's office, "NDs'
inability to perform CLIA waived tests can compromise patient
safety by delaying the testing and the results (for example,
needing to run a urine dipstick or a rapid strep culture in
suspected infections, or determining pregnancy status, which
could change the diagnosis and prescription).
"Additionally, NDs inability to hire staff to perform simple
tasks places an unnecessary burden on the doctors who are
required to perform all of these functions themselves. This
bill will create jobs by allowing NDs to hire NAs."
Background . CLIA specified that laboratory requirements be
based on the complexity of the test performed and established
provisions for categorizing a test as waived. Waived tests are
defined as simple laboratory examinations and procedures that
are cleared by the Food and Drug Administration for home use;
they must 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.
NDs may currently order and perform physical and laboratory
examinations for diagnostic purposes, including, but not limited
to phlebotomy, clinical laboratory tests, and speculum
examinations. A ND may also order diagnostic imaging studies,
dispense, administer, order, and prescribe or perform the
following: food, extracts of food, nutraceuticals, botanical
medicines, homeopathic medicines, dietary supplements, and
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non-prescription drugs, as specified; hot or cold hydrotherapy
and other physical medicine; devices; health education and
health counseling; repair and incidental care to superficial
lacerations and abrasions; and removal of foreign bodies located
in the superficial tissues.
The Act also authorizes a ND to furnish or order drugs when they
are ordered in accordance with standardized procedures or
protocols developed by the ND and his or her supervising
physician. The Act also specifies that a physician and surgeon
shall not supervise more than four NDs at one time.
This measure would revise the definition of a clinical
laboratory director to include a ND for purposes of a clinical
examination classified as waived. According to the Department
of Public Health, there are currently approximately 19,000
clinical laboratories in California, 3,000 of which are licensed
laboratories performing moderate and/or high complexity testing.
The remaining are registered labs performing waived tests
and/or provider-performed microscopy. California clinical
laboratories are subject to both federal and state oversight.
This bill establishes a definition of a NA for purposes of the
Act, and would authorize those NAs to perform certain medical
procedures under the supervision of a ND. Similarly, the
Medical Practice Act defines a MA as a person who may be
unlicensed, performs basic administrative, clerical and
technical supportive services to a number of health care
practitioners including physicians and surgeons, podiatrists,
nurse practitioners, or physician assistants. According to the
Center for Health Professions at the University of California
San Francisco, MAs are multi-skilled health care practitioners
trained to assist physicians; physician assistants, and nurse
practitioners with administrative and/or clinical duties in an
ambulatory care setting. NAs may also be trained to administer
immunizations, draw blood, run basic laboratory tests, and
perform electrocardiograms. There is no enforcement agency for
quality control of MAs and responsibility for supervision occurs
at the physician level in small practices, or at the operations
management level in larger practices.
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It is anticipated that the functions performed by NAs would be
similar to those of MAs, and the oversight and responsibility
for the supervision and training of NAs would be consistent with
those provided to MAs.
Arguments in support . California Naturopathic Doctors
Association writes, "Currently, patient safety is compromised
because naturopathic doctors cannot legally perform [CLIA
waived] tests during an office visit. The tests provide results
within minutes for a suspected urinary tract infection or strep
throat, for example - results which can otherwise take days.
This delay can lead to the worsening of a patient's condition or
unnecessary medication. Pregnancy status could also be
determined immediately. This is important because it can
significantly affect decisions about diagnosis or drug
treatment. This legislation would designate NDs as lab
directors for CLIA waived tests only (not for more complex
tests). Specifically, it adds NDs to the category of lab
directors that currently includes MDs and DOs. This bill does
not expand the type or number of tests that would be considered
waived."
Arguments in opposition . California Academy of Family
Physicians (CAFP) writes, "Given the recent changes in the
regulatory environment for both current and forthcoming NDs,
this bill seems premature. There is currently a bill being
considered by the legislature (SB 1050) with support from the
organization representing NDs which would reconstitute the
Naturopathic Medicine Committee with a majority of NDs holding
seats. [Because of] the newness of the ND's practice Act in
California and the rapid expansion of their profession, we would
recommend that a panel of experts be established to review
patient safety issues that could emerge from this expansion of
scope of practice. That panel should comprise representatives
of the medical community, the ND community, as well as
consumers. It should review the literature, as well as any
recent violations of the Act, and deliver recommendations for
both the use of assistants and any expansion of laboratory
services.
"Although the NDs argue that a misstep in applying waived tests
would not result in any serious consequences, this may not be
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the case in all circumstances. Simple tests, poorly done, may
not directly harm patient health. But they could invite error
and confusion into the treatment process and waste resources.
CAFP believes these potential issues should be examined more
comprehensively to avoid any inadvertent consequences."
Previous legislation . SB 907 (Burton), Chapter 485, Statutes of
2003, established the Naturopathic Doctor Act, to be
administered by the Bureau of Naturopathic Medicine (Bureau)
within the Department of Consumer Affairs. The Bureau would
establish standards for licensure and regulation of naturopathic
medicine.
Related legislation . SB 1050 (Yee) of 2010 revises the
membership of OMBC and the committee, and clarifies the duties
and responsibilities of the committee. This bill will be heard
in Assembly Health Committee on June 22, 2010.
REGISTERED SUPPORT / OPPOSITION :
Support
California Naturopathic Doctors Association (sponsor)
Opposition
California Academy of Family Physicians
California Clinical Laboratory Association
Analysis Prepared by : Sarah Weaver / B.,P. & C.P. / (916)
319-3301