BILL ANALYSIS
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|Hearing Date:April 12, 2010 |Bill No:SB |
| |1246 |
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SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Gloria Negrete McLeod, Chair
Bill No: SB 1246Author:Negrete McLeod
As Amended:April 5, 2010 Fiscal: Yes
SUBJECT: Naturopathic medicine.
SUMMARY: 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.
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
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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) the
Laboratory Field Services (LFS) 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 (PPM), 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.
9)Defines laboratory director as any person who is duly licensed
physician and surgeon, or is licensed to direct a clinical
laboratory and who meets specified qualifications under CLIA for
the type and complexity of tests being offered by the
laboratory. States that the laboratory director is responsible
for the overall operation and administration of a clinical
laboratory, as specified.
10)Defines a medical assistant 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
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amount of hours of training as specified. Defines technical
supportive services as simple routine medical tasks and
procedures that may be safely performed by medical assistants
who has limited training and who functions under the
supervision.
11)Authorizes medical assistants 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.
12)Requires the MBC to adopt and administer regulations that
establish standards for technical supportive services that may
be performed by medical assistants.
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 clinical licensing 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
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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 or 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 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 and dressings.
c) Collect by noninvasive techniques and preserve specimens for
testing, including urine, sputum, semen, and stool.
d) Assist patients in ambulation and transfers.
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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.
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.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. The California Naturopathic Doctors Association is the
Sponsor of this measure. The Sponsor states that a naturopathic
doctor's inability to perform CLIA waived 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
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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.
2.Background.
a) 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 X4 20
(Strickland) Chapter 18, Statutes of 2008, 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 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 or 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
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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.
b) Clinical Laboratories. This measure would revise the
definition of a clinical laboratory director to include a
naturopathic doctor for purposes of a clinical examination
classified as waived. According to DPH, 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 12,000 are registered
labs performing waived tests and/or provider-performed
microscopy. California clinical laboratories are subject to both
federal and state oversight.
Federal CLIA requirements establish standards for laboratories to
ensure the accuracy, reliability, and timeliness of patient test
results, and specify numerous quality standards, including those
for facility administration, personnel qualifications, quality
control, and proficiency testing, a process used by laboratories
to verify the accuracy and reliability of their test results.
CLIA standards apply to laboratory testing in all states, and in
all settings, including commercial, hospital, or physician office
laboratories. CLIA standards are based on the complexity of the
testing (waived, moderate, or high complexity).
A clinical laboratory performing clinical laboratory tests or
examinations subject to a certificate of waiver or a certificate
of provider-performed miscroscopy under CLIA is required to
register with DPH. DPH requires that an application for a
clinical laboratory license or registration must include certain
information, including the name of the owner, the name of the
laboratory director, 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.
c) CLIA Waived Tests. This bill would include naturopathic
doctors in the list of health care practitioners who could
perform a clinical laboratory test or examination classified as
waived. CLIA defines 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
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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. Waived tests
include dipstick or Tablet reagent urinalysis (use to test
glucose, hemoglobin, and protein among other things); Fecal
occult blood; Ovulation tests; Urine pregnancy tests; Erythrocyte
sedimentation rate-non-automated; Blood glucose by glucose
monitoring devices cleared by the FDA specifically for home use.
Amendments adopted for CLIA states that tests approved by the FDA
for home use automatically qualify for CLIA waiver. Professional
use versions of home use tests are not automatically waived.
However, such professional versions do qualify for expedited
waiver review since only the differences between the home use and
professional use versions need to be examined to determine
whether the professional version qualifies for waiver.
d) Naturopathic Assistants Practice and Training Requirements
Will be Similar to Medical Assistants. This bill establishes a
definition of a naturopathic assistant for purposes of the Act,
and would authorize those assistants to perform certain medical
procedures under the supervision of a naturopathic doctor.
Similarly, the Medical Practice Act defines a medical assistant
as a person who may be unlicensed, who performs basic
administrative, clerical and technical supportive services to a
number of health care practitioners including physicians and
surgeons, podiatrists, nurse practitioner or a physician
assistant. According to the Center for Health Professions at the
University of California San Francisco (Center), medical
assistants 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. The Center points out that medical assistants are
responsible for the smooth flow of patients or "throughput" of a
medical practice. Administrative or "front office" duties are
clerical in nature and include appointment scheduling, medical
record management, insurance billing, telephoning pharmacy
refills, and transcribing. Clinical or "back office" duties
relate to patient care, and include obtaining vital signs and
assisting with medical examinations. They 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 medical assistants and responsibility for
supervision occurs at the physician level in small practices or
operations management level in larger practices. Medical
assistants are authorized to administer medications by
intramuscular, subcutaneous and intradermal injections, to
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perform skin tests, or to perform venipuncture or skin puncture
for purposes of withdrawing blood after undergoing minimum
training prescribed by the MBC
It is anticipated that with establishment of the new category of
naturopathic assistant, that the functions performed would be
similar to medical assistants and that the oversight and
responsibility for the supervision and training of the
naturopathic assistant would be consistent with that provided to
medical assistants.
3.Author's Technical Amendments. The Author proposes to amend this
bill to clarify that the provisions including a naturopathic
assistant to the list of persons who could perform a clinical
laboratory test or examination classified as waived, as specified,
be included in the provisions that applies to waived tests, instead
of its current placement in the subsection dealing with clinical
laboratory tests or examinations classified as of moderate
complexity.
On page 2, line 18, insert:
(14) 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.
On page 4, strike out lines 12 - 15.
(11) A naturopathic assistant, as defined in Sections 3613 and
3640.2, if the waived test is performed pursuant to a specific
authorization meeting the requirements of Sections 3613 and 3640.2.
SUPPORT AND OPPOSITION:
Support:
California Naturopathic Doctors Association (Sponsor)
Opposition:
None on file as of April 6, 2010
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Consultant:Rosielyn Pulmano