BILL ANALYSIS �
SB 492
Page 1
Date of Hearing: June 24, 2014
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Susan A. Bonilla, Chair
SB 492 (Hernandez) - As Amended: June 16, 2014
SENATE VOTE : 25-5
SUBJECT : Optometrists: practice: licensure.
SUMMARY : Creates an advanced practice certificate, enabling
optometrists to perform a limited range of therapeutic laser
procedures for the eye and surgical procedures related to the
eyelid, as well as certain injections and immunizations, and
generally revises the Optometry Practice Act to clarify and
expand the range of an optometrist's scope of practice.
Specifically, this bill :
1)Includes the provision of habilitative optometric services in
the definition of the practice of optometry.
2)Authorizes an optometrist who is certified to use therapeutic
pharmaceutical agents (TPA) to diagnose and treat the human
eye or any of its appendages for all of the following
conditions:
a) The lacrimal gland, lacrimal drainage system and the
sclera in patients under the age of 12;
b) Ocular inflammation of the anterior segment and adnexa
nonsurgical in cause, except when co-managed with the
treating physician and surgeon. Removes limitations
relating to the treatment of ocular inflammation, referral
to an ophthalmologist, and the requirement that the
optometrist consult with an ophthalmologist or appropriate
physician in certain recurring cases;
c) Corneal surface disease and dry eyes, including
treatment with the use of mechanical lipid extraction of
meibomium glands using nonsurgical techniques; and,
d) Eyelid disorders, including hypotrichosis and
blepharitis.
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3)Deletes the requirement that optometrist use only a specified
list of TPAs, and instead authorizes an optometrist to use all
TPAs approved by the Food and Drug Administration (FDA) for
use in treating eye conditions with the scope of practice, ,
although the use of those agents shall be limited to a maximum
of five days.
4)Deletes requirements that optometrists who are certified to
use TPAs refer patients with certain conditions to
ophthalmologists only, as specified.
5)Revises consultation provisions related to the maintenance of
written records to apply to all physician and surgeons,
instead of only ophthalmologists.
6)Requires, in any case that an optometrist consults with a
physician, that the optometrist and the physician both
maintain a written record in the patient's file of the
information provided to the physician, the physician's
response, and any other relevant information. Upon the
request of the optometrist or physician and with the patient's
consent, a copy of the record shall be furnished to the
requesting party.
7)Allows TPA-certified optometrists to remove sutures, upon
notification of the treating physician, instead of upon prior
consultation.
8)Deletes the specific authorization for TPA-certified
optometrists to administer oral fluorescein to patients
suspected as having diabetic retinopathy.
9)Deletes the list of specific tests that TPA-certified
optometrists are permitted to order, and instead permits
optometrists to order any appropriate laboratory and
diagnostic imaging tests necessary to diagnose conditions of
the eye or adnexa.
10)
Clarifies that a TPA-certified optometrist may perform a clinical
laboratory test or examination necessary to diagnose
conditions of the eye or adnexa classified as waived under the
federal Clinical Laboratory Improvement Amendments of 1988
(CLIA), provided the tests are performed in compliance with
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both state and federal law, as specified, and that any
ancillary personnel utilized shall be in compliance with those
same requirements.
11)
Deletes the restriction on the use of needles in the removal of
foreign bodies from the eye.
12)
Requires the California Board of Optometry (Board) to certify any
optometrist who graduated from an accredited school of
optometry before May 1, 2000, to perform lacrimal irrigation
and dilation, excluding probing of the nasal lacrimal tract,
after submitting proof of satisfactory completion of 10
procedures under the supervision of a lacrimal irrigation and
dilation certified optometrist.
13)
Deletes obsolete language pertaining to glaucoma certification.
14)
Requires the Board to grant a glaucoma-certified optometrist a
certificate for the use of specified advanced procedures after
the optometrist meets the following applicable requirements:
a) For licensees who graduated from an accredited school of
optometry that includes satisfactory curriculum on advanced
procedures, as determined by the Board, on or after May 1,
2016, submission of proof of graduation from that
institution; or,
b) Licensees who graduated from an accredited school before
May 1, 2016, are required to submit proof of completion of
a Board-approved course that meets all of the following
requirements:
i) Provided by an accredited school of optometry;
ii) Taught by full-time or adjunct faculty members of an
accredited school of optometry;
iii) Sponsored by a continuing education organization, as
specified;
iv) Included all of the following didactic instruction:
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laser physics, hazards, and safety; biophysics of laser;
laser application in clinical optometry; laser tissue
interaction; laser indications, contraindications, and
potential complications; gonioscopy; laser therapy for
open angle glaucoma; laser therapy for angle closure
glaucoma; posterior capsulotomy; common complications:
lids, lashes, and lacrimal; medicolegal aspects of
anterior segment procedures; peripheral iridotomy; laser
trabeculoplasty; minor surgical procedures; overview of
surgical instruments, asepsis, and the federal
Occupational Safety and Health Administration; surgical
anatomy of the eyelids; emergency surgical procedures;
chalazion management; epilumeninesence microscopy; suture
techniques; local anesthesia: techniques and
complications; anaphylaxsis and other office emergencies;
radiofrequency surgery; and post-operative wound care;
v) Included all of the following clinical or laboratory
experience: video demonstration; a minimum of six
procedures involving the removal, destruction, or
drainage of eye lesions and 14 laser eye procedures
involving the removal, destruction, or drainage of
lesions of the eyelid and adnexa clinically evaluated to
be noncancerous; a formal clinical or laboratory
practical examination; and,
vi) Required passage of a written test utilizing the
National Board of Examiners in Optometry format.
15)
Defines the term "advanced procedures" as meaning any of the
following:
a) Therapeutic lasers used for posterior capsulotomy
secondary to cataract surgery;
b) Therapeutic lasers appropriate for treatment of glaucoma
and peripheral iridotomy for the prophylactic treatment of
angle closure glaucoma;
c) Removal, destruction, or drainage of lesions of the
eyelid and adnexa clinically evaluated to be noncancerous;
d) Closure of a wound resulting from the removal,
destruction, or drainage of lesions of the eyelid and
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adnexa clinically evaluated to be noncancerous; and,
e) Injections for the treatment of conditions of the eye
and adnexa that a TPA-certified optometrist may treat, as
specified, excluding intraorbital injections and injections
administered for cosmetic effect.
16)
Requires the Board to grant to a glaucoma-certified optometrist a
certificate to administer immunizations after the optometrist
meets all of the following applicable requirements:
a) For licensees who graduated from an accredited school of
optometry that includes satisfactory curriculum on
immunizations, as determined by the Board, on or after May
1, 2016, submission of proof of graduation from that
institution; and,
b) Licensees who graduated from an accredited school before
May 1, 2016, shall do all of the following:
i) Submit proof of completion of a Board-approved
immunization training program that, at a minimum,
includes hands-on injection technique, clinical
evaluation of indications and contraindications of
vaccines, and the recognition and treatment of emergency
reactions to vaccines, and shall maintain that training;
ii) Be certified in basic life support; and,
iii) Comply with all state and federal recordkeeping and
reporting requirements, including providing documentation
to the patient's primary care provider and entering
information in the appropriate immunization registry
designated by the immunization branch of the State
Department of Public Health.
17)
Authorizes the administration of immunizations for influenza,
Herpes Zoster Virus, and additional immunizations that may be
necessary to protect public health during a declared disaster
or public health emergency for individuals over the age of
eight.
18)
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Authorizes the Board to authorize optometrists to use any
noninvasive technology to treat any condition specified as
treatable by a TPA-certified optometrist, as specified.
19)
States that it is the intent of the Legislature that the Office of
Statewide Health Planning and Development (OSHPD), under the
Health Workforce Pilot Projects Program (HWPPP), designate a
pilot project intended to test, demonstrate, and evaluate
expanded roles for optometrists in the performance of
management and treatment of diabetes mellitus, hypertension,
and hypercholesterolemia.
20)
Specifies that an optometrist diagnosing other diseases shall be
held to the same standard of care to which physicians and
osteopathic physicians are held.
21)
Requires an optometrist to consult with, and if necessary, refer a
patient to a physician or other appropriate health care
provider if a situation or condition occurs that is beyond the
optometrist's scope of practice.
22)
Deletes from the definition of unprofessional conduct:
a) The commission of any act of sexual abuse, misconduct,
or relations with a patient, as specified; or
b) Conviction of a crime that currently requires the person
to register as a sex offender, as specified.
23)
Provides that no reimbursement is required by this act because the
only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime
or infraction, eliminates a crime or infraction, changes the
penalty for a crime or infraction, or changes the definition
of a crime.
24)
Makes other technical or nonsubstantive changes or deletions.
EXISTING LAW:
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1)Establishes the Board within the Department of Consumer
Affairs, which licenses optometrists and regulates the
practice of optometry. (Business and Professions Code (BPC)
Section 3010.5)
2)Authorizes the Board to establish educational and examination
requirements for licensure. (BPC 3041.2)
3)Defines the practice of optometry as follows:
a) The prevention and diagnosis of disorders and
dysfunctions of the visual system;
b) Treatment and management of certain disorders and
dysfunctions of the visual systems;
c) Provision of rehabilitative optometric services;
d) Examination of the human eyes;
e) Determination of the powers or range of human vision;
f) The prescribing or directing the use of any optical
device in connection with ocular exercises, visual
training, vision training or orthoptics;
g) Prescribing of contact lenses and glasses; and
h) The use of topical pharmaceutical agents for the purpose
of the examination of the human eye or eyes for any disease
or pathological condition. (BPC 3041)
4)Specifies that an optometrist who is certified to use
therapeutic pharmaceutical agents may also diagnose and treat
the human eye or eyes or any of its appendages for the
following conditions: infections; ocular allergies; ocular
inflammation, non-surgical in cause except when co-managed
with the treating physician and surgeon; traumatic or
recurrent conjunctival or corneal abrasions and erosions;
corneal surface disease and dry eyes; ocular pain,
non-surgical in cause except when co-managed with the treating
physician and surgeon; and glaucoma in patients over the age
of 18. (BPC 3041(b)(1))
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5)Permits optometrists to use specified therapeutic
pharmaceutical agents, including codeine with compounds and
hydrocodone with compounds provided that use does not exceed
three days. (BPC 3041(c))
6)Specifies that an optometrist who is certified to use
therapeutic pharmaceutical agents may also perform the
following:
a) Corneal scraping with cultures;
b) Debridement of corneal epithelia;
c) Mechanical epilation;
d) Venipuncture for testing patients suspected of having
diabetes;
e) Suture removal, with prior consultation with the
treating physician and surgeon;
f) Treatment or removal of sebaceous cysts by expression;
g) Administration of oral fluorescein to patients suspected
as having diabetic retinopathy;
h) Use of an auto-injector to counter anaphylaxis;
i) Ordering of smears, cultures, sensitivities, complete
blood count, mycobacterial culture, acid fast stain,
urinalysis, tear fluid analysis and X-rays necessary for
the diagnosis of conditions or diseases of the eye or
adnexa;
j) A clinical laboratory test or examination classified as
waived under CLIA necessary for the diagnosis of conditions
and diseases of the eye or adnexa;
aa) Punctal occlusion by plugs, excluding laser, diathermy,
cryotherapy or other means constituting surgery;
bb) The prescription of therapeutic contact lenses,
including lenses or devices that incorporate a medication
or therapy the optometrist is certified to prescribe or
provide;
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cc) Removal of foreign bodies from the cornea, eyelid and
conjunctiva with any appropriate instrument other than a
scalpel or needle; and
dd) Lacrimal irrigation and dilation, excluding probing of
the nasal lacrimal tract for patients over 12 years of age.
(BPC 3041(e))
FISCAL EFFECT : Unknown
COMMENTS :
1)Purpose of this bill . This bill would create an advanced
practice certificate which would enable an optometrist to
perform a limited range of therapeutic laser procedures for
the eye and certain surgical procedures related to the eyelid,
as well as related injections and specified immunizations. SB
492 also generally revises the Optometry Practice Act to
clarify and expand the range of the optometrist's scope of
practice as well as the drugs that may be prescribed and
diagnostic tests that may be ordered. This bill is sponsored
by the California Optometric Association.
2)Author's statement . According to the author, "[A]s a result of
implementation of the [Affordable Care Act] (ACA), about 4.7
million more Californians are now eligible for health
insurance and the newly insured will increase demand for
health care on an already strained system. Californians
deserve timely access to high quality care offered by a range
of safe, efficient, and regulated providers. In California we
have a robust network of providers that are well-trained,
evenly distributed throughout the state, regulated by the
Department of Consumer Affairs and well positioned to pay
particular attention to currently underserved areas.
Optometrists are one such provider group who receive a
doctorate level training preparing them to be primary eye care
providers, and independently diagnose and treat conditions of
the eye."
"SB 492 will remove restrictions in current law to permit
optometrists to examine, prevent, diagnose, and treat
conditions and disorders of the visual system and the human
eye to the full extent of their training. This includes the
use of two types of therapeutic lasers developed for treatment
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of glaucoma and post-surgical cataract care, conditions that
disproportionately affect patient groups that generally lack
sufficient access to physicians. The bill is especially needed
to ensure Medi-Cal patients can get their eye conditions
treated in a timely manner with the latest technology.
Optometry already provides 81 percent of eye care delivered in
this state under the Medi-Cal program.
"SB 492 is a limited expansion of scope for optometrists that
is consistent with their education and training, and is a
logical advancement of the profession that has been proven
safe in other states. Moreover, the educational requirements
contained in this bill are substantially greater than those
required of optometrists in other states and exceeds the
minimum number of these procedures required for
ophthalmologists by the Accreditation Council for Graduate
Medical Education."
3)The practice of optometry . An optometrist (Doctor of Optometry
or O.D.) is an independent primary health care professional
for the eye. Optometrists examine, diagnose, treat, and
manage diseases, injuries, and disorders of the visual system,
the eye, and associated structures, as well as identify
related systemic conditions affecting the eye. ODs prescribe
medications, low vision rehabilitation, vision therapy,
spectacle lenses, contact lenses, and perform certain surgical
procedures. Optometrists have a narrower scope of practice
than do ophthalmologists, but are held to the identical
standard of care for the same treatments they provide.
An O.D. degree requires both an undergraduate education in a
college or university and four years of professional education
at a college of optometry. Some optometrists also undertake
an optional one year non-surgical residency program to enhance
their experience in a particular area. Students graduate with
2,500-3,000 patient encounters; these include a mix of
post-surgical, medical and routine visits.
In order to be licensed to practice by the California Board of
Optometry, an individual must obtain an O.D. degree, pass the
three part National Board of Examiners in Optometry
examination, and the California Optometric State Law
Examination. There are currently 9,100 optometrists in
practice in California.
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Optometrists are trained to diagnose mild to severe eye
problems such as serious eye infections, inflammations of the
eye, trauma, foreign bodies and glaucoma (pressure inside the
eyeball). They also examine the eye for vision prescription
and corrective lenses. Optometrists may also pursue any of
five additional state certifications to perform certain
advanced procedures: use of diagnostic pharmaceutical agents
(DPA); use of therapeutic pharmaceutical agents (TPA);
lacrimal irrigation and dilation for individuals over the age
of 12 + TPA (TPL); diagnosis and treatment of open angle
glaucoma for adults + TPA (TPG); and a combination of TPA, TPL
and TPG.
4)The practice of ophthalmology . An ophthalmologist is a
physician and surgeon (M.D.) who has specialty training in the
anatomy, function and diseases of the eye. The central focus
of ophthalmology is surgery and management of complex eye
diseases. An ophthalmologist specializes in the refractive,
medical and surgical care of the eyes and visual system, and
in the prevention of disease and injury.
To become an ophthalmologist, an individual must obtain an
undergraduate degree, complete four years of graduate
education at an accredited medical school and earn a Medical
Degree, complete a one year internship, and a three or four
year residency. Many ophthalmologists pursue additional
fellowship training in specialized areas such as the retina,
glaucoma treatment or the cornea. Ophthalmologists may become
certified by the American Board of Ophthalmology, which
requires serving as primary surgeon or first assistant to the
primary surgeon on a minimum of 364 eye surgeries.
There are currently 1,800-2,100 ophthalmologists in California,
not all of whom are in active practice.
5)2013-14 negotiations between optometry and ophthalmology . In
August 2013, the author declined to take up this bill during
its scheduled hearing, and instead asked the Chair and
Committee to hold a series of meetings to pursue negotiations
between optometry and medicine (ophthalmology). The aim was
to use a data-driven process to search for an objective and
defensible set of requirements towards the creation of an
optometric advanced practice certification.
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In response to the author's request, the Committee convened six
separate meetings during 2013 to hear expert testimony and
discuss key components of advanced practice: laser procedures,
surgical procedures, immunizations, and injections. The
Committee also conducted a tour of the UC Berkeley School of
Optometry. Formal discussions concluded in January without
consensus, although the working group had significantly
reduced the range of open issues.
Additional discussions between optometry and medicine continued
from January 2014 through June 2014, often, but not always,
with the Committee's involvement. By June, the parties had
largely narrowed down the range of procedures under
discussion, and were primary concerned with the minimum number
of supervised procedures required perform the procedures
safely and achieve certification. Unfortunately, the parties
were unable to find a mutually-agreeable objective standard to
bridge the remaining distance. Having failed to reach
consensus, this bill was amended on June 16, 2014 into its
current form to reflect the preferred position of the author
and the sponsor, the California Optometric Association.
6)Key components of this bill . SB 492 amends the Optometric
Practice Act in five significant ways:
a) Laser procedures : This bill lays out specified
educational and clinical experience requirements for
advanced practice certification in three therapeutic laser
procedures: posterior capsulotomy after cataract surgery;
trabeculoplasty for treatment of glaucoma; and peripheral
iridotomy for the preventative treatment of acute angle
closure glaucoma.
As a prerequisite, this bill would require a
glaucoma-certified optometrist to either have studied
specified content related to the laser procedures during
optometry school or have taken a Board-approved course on
the topic. The optometrist must also perform a minimum of
14 laser procedures of any of the three types to establish
certificate eligibility.
b) Surgical procedures : SB 492 specifies educational and
clinical experience requirements for advanced practice
certification for a limited set of surgical procedures:
removal, destruction, or drainage of non-cancerous lesions
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of the eyelid and adnexa (area immediately around the eye);
closure of a wound resulting from that removal, destruction
or drainage; and injections for the treatment of any
condition within scope of practice except intraorbital and
cosmetic injections.
As a prerequisite, this bill would require a
glaucoma-certified optometrist to either have studied
specified content related to the surgical procedures during
optometry school or have taken a Board-approved course on
the topic. The optometrist must also perform a minimum of
six procedures involving removal, destruction or drainage
of eye lesions to establish certificate eligibility.
c) Immunizations : This bill would authorize a
glaucoma-certified optometrist to administer immunization
shots to persons eight years of age and older for
influenza, Herpes Zoster Virus (shingles), and additional
immunizations that may be necessary to protect public
health during a declared disaster or public health
emergency. As a prerequisite, the optometrist must have
studied the topic of immunizations during optometry school
or have taken a Board-approved course on the topic of
indeterminate length, and also be certified in basic life
support.
d) Primary care : While this bill previously contained
language that would grant optometrists authority to test
and diagnose diabetes mellitus, hypertension and
hypercholesterolism, the current language simply states
that it is the intent of the Legislature that the OSHPD,
under the HWPPP, designate a pilot project intended to
test, demonstrate, and evaluate expanded roles for
optometrists in the management and treatment of diabetes
mellitus, hypertension, and hypercholesterolemia.
e) Other provisions : This bill also generally revises the
practice act for optometry to expand the kinds of
conditions that a TPA-certified optometrist may treat,
expands his or her ability to order lab tests, allows the
prescription of codeine and hydrocodone for five days
instead of three, and clarifies that optometrists may use
or diagnose any indicated therapeutic pharmaceutical agent
for conditions within their scope of practice. It also
generally authorizes any other noninvasive therapy approved
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by the Board, and makes multiple technical or
nonsubstantive amendments.
f) Evidence : As stated above, this bill requires the
completion of a specified number of procedures as a
prerequisite to advanced certification. The author
justifies these numbers primarily by referring to the
practice of other states. According to a 2013 presentation
to the SB 492 working group by a University of Oklahoma
optometrist, Oklahoma and Kentucky currently permit
optometrists to perform certain laser procedures after a
16-hour certification course. Similarly, the states of
Oklahoma, Kentucky, New Mexico, Oregon and others permit
optometrists to perform minor surgical procedures after a
16-hour certification course.
The Board of Examiners in Optometry for the State of Oklahoma
states that optometrists in Oklahoma have had authority to
perform minor surgical procedures for 25 years, and have
had authority to use lasers for more than 10 years. In
that time, the Oklahoma Board states that it is has had no
formal or informal complaints from any party regarding the
use of any anterior segment surgical procedures or laser
surgery, and that there is no difference in the
complication rates (less than 1%) between ophthalmologists
and optometrists. However, repeated requests to the author
and sponsor for reports, studies or additional data yielded
no additional information regarding outcomes.
7)The alternative proposal from ophthalmology . As an outgrowth
of the discussions between optometry and ophthalmology over
the past nine months, the California Academy of Eye Physicians
and Surgeons (CAEPS) in June offered its own parallel proposal
for an optometric advanced practice designation. In order to
better highlight areas of agreement and disagreement between
the stakeholders, a summary of that proposal is provided
below.
a) Laser procedures : CAEPS recommended expanded authority
to perform two procedures (trabeculoplasty and posterior
capsulotomy), and that an optometrist should perform a
minimum of 16 capsulotomies, 12 trabeculoplasties, and
seven more of either type for a total of at least 35
procedures. CAEPS also recommended that each procedure must
be directly supervised and followed through to completion
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in order to count towards certification.
b) Surgical procedures : CAEPS recommended that
optometrists perform a minimum of 18 lid lesion removals,
11 lid lesion repairs, 10 chalazia/cysts drains, and 36
additional surgical procedures for a total of 75 surgical
procedures, along with 20 intravenous angiographies and at
least 75 anesthetic injections, as a basis for
certification. As with lasers, each procedure must be
complete and supervised.
c) Immunizations : While immunizations are more commonly
viewed as the domain of family physicians, authorization to
perform a small number of vaccinations after completing a
standard 20 hour Center for Disease Control-approved course
and life support certification had been discussed and
considered by a broader spectrum of physicians.
d) Primary care : CAEPS did not directly address the
question of involvement in primary care management of the
three chronic conditions, although the question was raised
as to whether it was appropriate for the Legislature to
even make statements of legislative intent regarding an
OSHPD study when such studies are generally approved or
denied regardless of outside influence.
e) Other provisions : CAEPS contends that oversight of the
certification program, approval of curricula, and even
advising on disciplinary matters, would require a board
comprised of members from both the Medical Board of
California and the Board. Joint oversight would transition
to the Board over the course of 7-10 years as the number of
certified optometrists with practice performing the
procedures in question grows.
f) Evidence : CAEPS states that the Residency Review
Committee for ophthalmology programs has published averages
and minimums for the training of ophthalmologists in
certain procedures. It notes that these minimums are
expected to be considered in the context of the hundreds or
even thousands of other procedures that require similar
skill sets and provide complimentary experience. Moreover,
these minimum numbers are also achieved within a process of
classroom and clinical training in diagnosis and management
of complex diseases, acquisition of suturing skills, and
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completion of in-hospital and outpatient clinic activities
with human patients that reinforce the training.
RRC currently reports an average of 67 laser retina
procedures during ophthalmological training, with a
"minimum being 24 procedures (posterior capsulotomy has an
average of 16 procedures with a minimum of five, and
trabeculoplasty has an average of 12 procedures and a
minimum of five)
RRC also reports an average of 400 surgical procedures and a
minimum of 140, with lid lesion removal averaging 18
procedures (no clearly specified minimum), lid repair
averages 11 procedures and a minimum of three, and at least
three chalazion removals. For injections, the average is
over 100 intravenous procedures, and roughly 400 anesthetic
injections.
8)Questions for the Committee . As with any bill of this scale
and complexity, there are a number of issues raised by this
bill in its current form, the most salient of which are
summarized below:
The core issue between medicine and optometry for advanced
practice optometry is the amount of practice necessary to
ensure that the optometrist can independently perform the
procedure safely. As noted above, this bill requires 14
procedures total to perform 3 laser therapies, without
individual requirements for each procedure. The last proposal
from CAEPS suggested a minimum 35 procedures total for 2 laser
therapies, with subset requirements for each.
CAEPS contends that "[w]ith regard to the numbers of procedures
required, we maintain our position as stated throughout our
conversations that the only way to learn to do procedures is
to actually do them. Repetition of the required steps and
activities develops surgical facility and acumen.
Furthermore, increased numbers provide greater opportunity to
monitor response and see and address complications under
supervision before independent practice. The numbers in the
bill are a small fraction of those recommended by Medicine's
proposal, and cannot credibly prepare someone for independent
practice." (emphasis removed) Additionally, the omission of
subset requirements means that an optometrist could be
certified to perform all of the listed procedures by
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repeatedly performing only one type of laser or surgical
procedure until the total minimum is met.
CAEPS also raises a concern that the bill contains no clear
standards for training of optometric students graduating in
2016, as it leaves to the Board the approval of a satisfactory
curriculum for the use of all advanced procedures.
Additionally, while the bill does specify course content for
classroom training of pre-2016 optometry school graduates,
this bill does not specify a minimum number of hours of
training, and leaves all other matters to the approval of the
Board.
The Committee may wish to inquire of the author and
stakeholders as to the evidentiary basis for the minimum
number of procedures sufficient to ensure patient safety, and
also what justification exists for not requiring specific
course content, a minimum number of training hours for
pre-2016 graduates, and minimum procedure subsets.
Finally, CAEPS raises a number of individual concerns about
the specificity of the scope expansion represented by this
bill. For surgery, there is no limit of location or depth of
the lesion removal, which is concerning because surgery on
lesions close to or on the tear duct or eyelid margin can be
difficult and have potential for serious complications. As
for the laser procedures, iridotomy was never discussed in
great length during negotiations and no subsets were
researched, meaning that the minimum safe number of laser
procedures should be even higher than the recommended 35
because that number encompassed only two laser procedures.
The bill language pertaining to injections is also concerning
because it appears to permit injections into the eyeball
itself, and does not contain standards for safe equipment
handling. SB 492 also does not limit vaccination to adults,
which raises the concern of family physicians because of the
potential to interrupt the regular vaccination schedule and
record keeping, and because it would supplant the normal
relationship between a child and their pediatrician. CAEPS
also believes that the program should be implemented by a
joint committee of optometrists and ophthalmologists, given
that there would be so few optometrists with experience
performing the procedures, at least initially. The Committee
may wish to inquire of the author and sponsor as to how these
concerns should be addressed.
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As noted above, this bill states the intent of the Legislature
that OSHPD, through HWPP, run a pilot project to study the
possibility of allowing optometrists to manage and treat
non-visual system conditions such as diabetes, high blood
pressure and high cholesterol.
The purpose of HWPP is to test, demonstrate and evaluate new
or expanded roles for healthcare professionals before changes
in licensing laws are made by the Legislature. An HWPP study
can take 2-3 years to complete, or sometimes longer, but can
lead to reliable data justifying substantial expansions to
scope of practice. For example, AB 154 (Atkins) (Chapter 662,
Statutes of 2013) authorized nurse practitioners, certified
nurse midwives, and physician assistants to perform an
abortion by aspiration techniques during the first trimester
of pregnancy - and began as a HWPP 171 pilot project in 2007.
To the extent that the procedures requested in this bill lack
sufficient objective data to demonstrate the proper minimum
level of training needed to be safely performed, the Committee
may consider whether additional provisions of this bill should
be considered for an HWPP study in the absence of consensus or
more determinative data.
Separately, this bill removes two provisions from the list
that defines unprofessional conduct by an optometrist:
commission of any act of sexual abuse, misconduct or relations
with a patient; and conviction of a crime that requires
registration as a sex offender. The bill retains a more
narrow provision related to conviction of a sexual crime if
related to the qualifications, functions, or duties of
optometric practice. The reason for this narrowing was not
provided by the author. The Committee may wish to inquire of
the author as to why a narrowing of the standard for sexual
misconduct is appropriate.
9)Arguments in support . According to the sponsor, the
California Optometric Association, "[t]his bill would allow
certified doctors of optometry to remove small lumps and bumps
from the eye lid and use two different kinds of lasers that
have very low complication rates. It would also create a
separate immunization certification that would authorize
doctors of optometry to administer two immunizations, flu and
shingles. This bill is a limited expansion of scope for
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optometrists that is consistent with their education and
training, and is a logical advancement of the profession that
has been proven safe in other states.
"Doctors of optometry can help fill the provider gap. There are
more than three times as many optometrists as they are
ophthalmologists practicing in California. Many optometrists
practice in rural and medically underserved areas. Doctors of
optometry provide 81 percent of the eye care in the Medi-Cal
program. As more Californians obtain health coverage, more
physicians retire and baby boomers age, SB 492 will ensure
patients have access to qualify eye care in their communities.
"Amendments were made to the bill to address many of the
concerns of the opposition. For example, SB 492 was amended on
June 16 to: Eliminate the express authority to diagnose
diabetes, high blood pressure and high cholesterol. The
ability to treat these conditions with medications was removed
earlier; specify the classroom and lab education required to
include a minimum of six procedures involving the removal,
destruction of draining of eye lesions and 14 laser eye
procedures; require a formal clinical or laboratory practical
examination and a written test; limit the scope authorized by
prohibiting suture or cauterization of a cut on the eye; and
require the same immunization record keeping and reporting
requirements as pharmacists.
"The additional training now required by SB 492 is much more
than any other state in the nation. It is also more than the
minimum number of procedures required for graduating residents
in ophthalmology developed by the Accreditation Council for
Graduate Medical Education (ACGME). Medicine's proposal for
optometrists to perform a minimum of 130 procedures is six
times the number of minimum procedures that ophthalmologists
must complete. What they have offered is so onerous that no
reasonable person could be expected to complete it and as a
result, California patients will continue to be without timely
access to much-needed care."
The California Pharmacists Association (CPhA) writes, "[t]his
bill would make important changes to update the Optometric
Practice Act reflecting optometrists' high level of training
and expertise. These changes will allow doctors of optometry
to improve access to needed services for health care consumers
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in California?"
"Optometrists are an important gateway into the healthcare
system. Many patients see optometrists before seeing other
healthcare providers. For this reason, it is beneficial to
patients and the health care delivery system as a whole to
utilize optometrists to the fullest extent of their training
and expertise. Optometrists are extensively trained and
educated pursuant to national standards and this bill's
educational requirements are substantially greater than those
required of optometrists in other states. The changes in this
bill will allow optometrists to safely provide valuable
services in their communities and improve access to health
care."
10)
Arguments in opposition . The California Medical Association writes
"SB 492 is a significant scope expansion that would allow
optometrists to perform eye surgery using scalpels and lasers
with very little additional training. In addition to allowing
optometrists to perform surgery the bill would allow
optometrists to prescribe and administer Latisse and Botox
which are generally cosmetic in nature."
"SB 492 provides the Board of Optometry with the authority to
determine whether or not the curriculum at an optometry school
addresses the advance procedures defined in the bill. In
addition, the '[B]oard approved' course does not specify the
length of the course or criteria for determining that the
criteria have been met. For both of these issues it is unclear
if regulations would be required or if it is within the
purview of the [B]oard to set criteria for approval.
"Another concern is that the bill is unclear about what is
noninvasive technology. There is currently authority for
treatment of conditions with therapeutic pharmaceutical
agents, however, it is unclear how adding noninvasive
technology further expands the scope of practice for
optometrist. SB 492 provides for an OSHPD study. It is
unclear whether the bill requires that OSHPD accept the study
because the legislature demands it or if it would go through
the normal process that includes public input before deciding
if OSHPD would accept the issue as a study.
According to the California Academy of Eye Physicians &
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Surgeons (CAEPS): "While we believe the proposal to be as
valid as it can be based on the recommendations of academic
people for whom we have great respect, given we proposed
ranges for the numbers of each type of surgery included in the
August 5, 2013 version of the bill, we are willing to admit
that some flexibility might exist. However, given the breadth
of potential complications?we feel this might be at most 10%
rather than the 60-90% reductions currently in the bill for
those graduating before May 1, 2016.
"We will point out that?there are no defined standards for
students graduating in 2016 and beyond other than the State
Board of Optometry deciding the school includes satisfactory
curriculum on advanced procedures, as determined by the
[B]oard. In fact, we estimate a typical optometry school will
be hard pressed to provide even ONE training case of each type
of procedure per student, meaning that the [B]oard could
'deem' such schools acceptable even though the experience was
far less than would be required of those in already practice.
In fact, the State Board of Optometry could (at its
discretion) consider ZERO cases with human experience to be
'adequate.'
"?we believe the strongest conclusion that can be drawn from
the data presented is that it is likely not possible for
everyone graduating from an optometry school to be credibly
trained in a way that would protect patient safety.
"Therefore, given the representatives of the COA were adamant
that every student who graduates on or after May 1, 2014 MUST
be able to be certified for the requested surgical procedures
upon graduation (as essentially part of the 'core' skills of
an optometry degree), it may be that optometry as a profession
needs to consider a paradigm shift of its own regarding that
part of their "model" in order to concentrate the available
training cases on those that they can actually train well,
rather than trying to reduce the needed training only ending
up with large numbers of people with inadequate training?.The
numbers in the bill are a small fraction of those recommended
by Medicine's proposal, and cannot credibly prepare someone
for independent practice." (emphasis removed)
The California Association for Medical Laboratory Technology
(CAMLT) writes: "CAMLT and the California Optometric
Association reached an accord on AB 761 (Roger Hern�ndez) in
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2012 which was signed into law and took effect January 1,
2013. This agreement was intended to ensure that there was no
future ambiguity about the scope of tests that optometrists
can perform. SB 492, as introduced on February 2013, undid
that agreement and the current version does not restore that
agreement?.The current version of SB 492 appears to extend the
scope of optometric laboratory testing and creates ambiguity
not only as to what is permitted, but their role as a
laboratory director. Clinical Laboratory Scientists themselves
(the very discipline trained in laboratory testing) only last
year received statutory authority to be a waived laboratory
director. CAMLT requests a return to the agreed upon language
in existing law."
The California Society of Plastic Surgeons writes "[SB 492]
will allow optometrists to perform elective cosmetic
procedures, including blepharoplasty procedures?Optometrists
do not have the training or education to perform complex
surgical procedures on the eyelid. Additionally, the
requirements for an optometrist to meet allowing them to
perform these surgical procedures?are nowhere near adequate to
ensure patient safety?.Surgical procedures on the eyelid are
complex and delicate procedures and if done incorrectly lead
to permanent disfigurement?.SB 492 sets a dangerous precedent
of allowing individuals with no training in doing injections
for cosmetic purposes."
The California Society of Anesthesiologists (CSA) states "CSA
believes this bill would greatly increase the potential for
patient harm and delayed diagnosis of serious blinding and
life threatening diseases?.Without a doubt, physician-led eye
care provides safe, efficacious and appropriate patient care.
However, eye physicians and surgeons are the ones who have
obtained nearly a decade of appropriate medical education and
training in the overall physical, clinical, imaging and
laboratory manifestations to evaluate, diagnose and treat all
eye diseases of the patient."
11)
Related legislation . SB 491 (Hern�ndez) of 2013 would delete the
requirement that Nurse Practitioners perform certain tasks
pursuant to standardized procedures and/or consultation with a
physician or surgeon and authorizes a Nurse Practitioner to
perform those tasks independently. This bill also requires,
after July 1, 2016, that Nurse Practitioners possess a
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certificate from a national certifying body in order to
practice. SB 491 was held under submission in the Assembly
Appropriations Committee.
SB 493 (Hern�ndez) (Chapter 469, Statutes of 2003) authorizes a
pharmacist to administer drugs and biological products that
have been ordered by a prescriber. This bill also expands
other functions pharmacists are authorized to perform, and
authorizes pharmacists to order and interpret tests for the
purpose of monitoring and managing the efficacy and toxicity
of drug therapies and to independently initiate and administer
routine vaccinations, and establishes Board recognition for an
advanced practice pharmacist.
12)Prior Legislation . SB 1406 (Correa) (Chapter 352, Statutes
of 2008) specified permissible procedures for certified
optometrists, and created the Glaucoma Diagnosis and Treatment
Advisory Committee to establish glaucoma certification
requirements.
SB 929 (Polanco) (Chapter 676, Statutes of 2000) expanded the
scope of lawful practice for optometrists by specifying
additional diseases and conditions that optometrists may treat
(in particular certain types of glaucoma) with specified
medications, and by specifying the extent of physician
involvement that is required under various circumstances.
SB 668 (Polanco) (Chapter 13, Statutes of 1996) expanded the
scope of practice of optometrists to provide for the diagnosis
and treatment of specified conditions or diseases of the human
eye or its appendages, and to use other therapeutic
pharmaceutical agents.
REGISTERED SUPPORT / OPPOSITION :
Support
California Optometric Association (sponsor)
California Pharmacists Association
Bay Area Council (7/19/2013)
Blue Shield of California (6/18/2013)
California Association of Nurse Practitioners (6/17/2013)
California Association of Public Hospitals and Health Systems
(8/1/2013)
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Californians for Patient Care (8/2/2013)
Dignity Health (8/5/2013)
St. Mary's Medical Center (8/9/2013)
United Nurses Association of California/Union of Health Care
Professionals (5/31/2013)
329 individuals
Opposition
Blind Childrens Center
California Academy of Eye Physicians and Surgeons (CAEPS)
California Academy of Family Physicians
California Association for Medical Laboratory Technology
California Diabetes Program
California Medical Association
California Right To Life Committee
California Society of Anesthesiologists
California Society of Plastic Surgeons
Diabetes Coalition of California
Let's Face It Together
Lighthouse for Christ Mission
Sansum Diabetes Research Institute
The Dream Machine Foundation
Alameda-Contra Costs Medical Association (7/23/2013)
American Academy of Pediatrics, California (7/30/2013)
American College of Emergency Physicians, California Chapter
(7/29/2013)
California Society of Dermatology and Dermatologic Surgery
(7/31/2013)
Engineers and Scientists of California, IFPTE (8/5/2013)
Here 4 Them, Inc. (6/19/2013)
Medical Board of California (7/25/2013)
Minority Health Institute, Inc. (7/23/2013)
Osteopathic Physicians and Surgeons of California (7/29/2013)
Professional Medical Clinic for Women Sacramento, Inc.
(7/25/2013)
South Central Family Health Center (6/10/2013)
Stanford University School of Medicine, Department of
Ophthalmology (7/30/2013)
The Aesthetic Institute (7/26/2013)
Time for Change Foundation (6/25/2013)
UC Davis Department of Ophthalmology and Vision Science
(7/29/2013)
UC Irvine Department of Ophthalmology
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UC San Francisco Department of Ophthalmology (7/30/2013)
Union of American Physicians and Dentists/AFSCME Local 206
(8/1/2013)
University of Southern California Department of Ophthalmology
(7/30/2013)
Ventura County American Chinese Medical Dental Association
(7/23/2013)
287 individuals
Analysis Prepared by : Hank Dempsey / B.,P. & C.P. / (916)
319-3301