BILL ANALYSIS �
-----------------------------------------------------------------------
|Hearing Date:May 2, 2011 |Bill No:SB |
| |100 |
-----------------------------------------------------------------------
SENATE COMMITTEE ON BUSINESS, PROFESSIONS
AND ECONOMIC DEVELOPMENT
Senator Curren D. Price, Jr., Chair
Bill No: SB 100Author:Price
As Amended:April 25, 2011 Fiscal:Yes
SUBJECT: Healing arts.
SUMMARY: Requires the Medical Board of California (MBC) to adopt
regulations on or before January 1, 2013, on the appropriate level
of physician availability necessary within clinics using laser or
intense pulse light devices for elective cosmetic surgery. Makes
a number of changes regarding the approval, oversight and
inspection of outpatient settings, as defined, by MBC and
accreditation agencies approved by the MBC, and in developing a
plan of corrective action for any deficiencies found by the
accreditation agencies or the MBC during inspections, or
otherwise. Revises the existing definition of "outpatient
settings" to include fertility clinics that offer in vitro
fertilization.
Existing law:
1)Requires the MBC in conjunction with the Board of Registered Nursing
(BRN), and in consultation with the Physician Assistant
Committee (PAC) and professionals in the field, to review issues
and problems relating to the use of laser or intense light pulse
devices for elective cosmetic procedures by physicians and
surgeons, nurses, and physician assistants.
2)Specifies that the review conducted by the MBC, the BRN and the PAC
shall include the appropriate level of physician supervision
needed, the appropriate level of training to ensure competency,
guidelines for standardized procedures and protocols that
address patient selection, education, instruction and informed
consent, use of topical agents, and procedures to be followed in
SB 100
Page 2
the event of complications or side effects from treatment and
procedures for governing emergency and urgent care situations.
3)Requires the MBC and the BRN to promulgate regulations to implement
changes determined to be necessary with regard to the use of
laser or intense pulse light devices for elective cosmetic
procedures by physicians and surgeons, nurses and physicians
assistants.
Existing law, the Health and Safety Code, Section 1248 et seq.:
1)Defines "outpatient setting" as any facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility where anesthesia is used.
2)Defines accreditation agency as a public or private organization
that is approved to issue certificates of accreditation to
outpatient settings by the MBC pursuant to specified
requirements.
3)Requires the MBC to adopt standards for accreditation of
outpatient settings, as defined, and in approving accreditation
agencies to perform accreditation of outpatient settings, ensure
that the certification program shall, at a minimum, include
standards for specified aspects of settings' operations.
4)Requires the MBC to obtain and maintain a list of all
accredited, certified, and licensed outpatient settings, and to
notify the public, upon inquiry, whether a setting is
accredited, certified, or licensed, or whether the setting's
accreditation, certification, or license has been revoked.
5)Requires accreditation of an outpatient setting to be denied by
the accreditation agency if the outpatient setting does not meet
specified standards and allows the outpatient setting to reapply
for accreditation at any time after receiving notification of
denial.
6)Authorizes the MBC or an accrediting agency to, upon reasonable
prior notice and presentation of proper identification, enter
and inspect any outpatient setting that is accredited by an
accreditation agency at any reasonable time to ensure compliance
with, or investigate an alleged violation of any standard of
accrediting agency or any provision of the specified law.
7)Authorizes the MBC to evaluate the performance of an approved
SB 100
Page 3
accreditation agency no less than every three years, or in
response to a complaint against an agency, or complaints against
one or more outpatient settings accreditation by an agency that
indicated noncompliance by the agency with standards approved by
the MBC.
8)Provides that before suspending or revoking a certificate of
accreditation, the accrediting agency shall provide the
outpatient setting with notice of deficiencies and reasonable
time to supply information demonstrating compliance with the
standards of the accrediting agency as well as the opportunity
for a hearing on the matter upon request of the outpatient
setting.
9)Defines treatment for infertility as procedures consistent with
established medical practices in the treatment of infertility by
licensed physicians and surgeons including, but not limited to,
diagnosis, diagnostic tests, medication, surgery, and gamete
intrafallopian transfer. Defines in vitro fertilization as the
laboratory medical procedures involving the actual in vitro
fertilization process.
10)Requires a health facility, as defined, to report an adverse
event to the Department of Public Health (DPH) no later than
five days after the adverse event has been detected, or, if that
even is an ongoing urgent or emergent threat to the welfare,
health, or safety of patients, personnel, or visitors, not later
than 24 hours after the adverse event has been detected.
Defines adverse event for purposes of reporting. Specifies that
a health facility that fails to report an adverse event may be
assessed by the DPH a civil penalty in an amount not to exceed
$100 for each day that the adverse event is not reported, as
specified.
This bill:
1)Requires the MBC to adopt regulations on or before January 1,
2013 regarding the appropriate level of physician availability
needed within clinics or other settings using laser or intense
pulse light devices for elective cosmetic procedures. Specifies
that the regulations to be adopted will not apply to laser or
intense pulse light devices approved by the federal Food and
Drug Administration for over-the-counter use by a health care
practitioner or by an unlicensed person on himself or herself.
2)Includes in the existing law definition of outpatient setting
SB 100
Page 4
facilities that offer in vitro fertilization procedures. Requires
the MBC to adopt standards for outpatient settings that offer in
vitro fertilization.
3)Requires an outpatient setting to submit for approval by an
accrediting agency at the time of accreditation, a detailed plan,
standardized procedures, and protocols to be followed in the event
of serious complications or side effects from surgery that would
place a patient at high risk for injury or harm or to govern
emergency or urgent care situations. Specifies that the plan shall
include, at a minimum, that if a patient is being transferred to a
local accredited or licensed acute care hospital, the outpatient
setting shall do all of the following:
a) Notify the individual designated by the patient to be notified
in case of emergency;
b) Ensure that the mode of transfer is consistent with the
patient's medical condition;
c) Ensure that all relevant clinical information is documented
and accompanies the patient at the time of transfer; and,
d) Continue to provide appropriate care to the patient until the
transfer is effectuated.
4)Allows the MBC to adopt regulations it deems necessary to specify
procedures that should be performed in an accredited outpatient
setting for facilities or clinics that are outside the definition
outpatient setting, as specified.
5)Requires the accrediting agency, as part of the accreditation
process, to conduct a reasonable investigation of the prior history
of the outpatient setting, including all physicians and surgeons who
have an ownership interest, to determine whether there have been any
adverse accreditation decisions, as specified. States that
conducting a reasonable investigation means querying the MBC and the
Osteopathic Medical Board of California to ascertain if either the
outpatient setting has, or, it its owners are licensed physicians
and surgeons, and if those physicians and surgeons have been subject
to an adverse accreditation decision.
6)Requires an outpatient setting to comply with existing adverse event
reporting requirements and penalties that apply to health
facilities.
SB 100
Page 5
7)Requires the MBC to place the list of accredited outpatient setting
it currently maintains on its Website on whether an outpatient
setting is accredited or the accreditation has been revoked,
suspended, or placed or probation, or the setting has received a
reprimand by the accrediting agency. Specifies that the list shall
include the name, address and telephone number of any owners and
their medical license numbers, name and address of the facility,
name and telephone number of the accreditation agency, and the
effective and expiration dates of the accreditation. Requires
accrediting agencies to provide and update the MBC on all outpatient
settings that are accredited.
8)Requires an accrediting agency to report within 3 business days to
the MBC if an outpatient setting's certificate for accreditation has
been denied for failure to meet the standards approved by the MBC,
as specified.
9)States that every outpatient setting shall be inspected by
accrediting agencies and may be inspected by the MBC. Includes the
following requirements in the inspection: a) The frequency of
inspection shall depend upon the type and complexity of the
outpatient setting to be inspected; and, b) inspections shall be
conducted no less than once every 3 years by the accrediting agency
and as often as necessary by the MBC to ensure quality of care
provided.
10)Requires, if an accreditation agency determines as a result of its
inspection that an outpatient setting is not in compliance with
standards, as specified, correction of any identified deficiencies
within a set timeframe. States that failure to comply would result
in the accrediting agency issuing a reprimand, suspending or
revoking the outpatient setting's accreditation.
11)Requires that prior to suspending or revoking a certificate of
accreditation, an outpatient setting must agree with the
accreditation agency on a plan of correction. Specifies that the
plan of correction, which includes the deficiencies, shall be
conspicuously posted in a location accessible to public view.
Provides that within 10 days after the adoption of the plan of
correction, the accrediting agency shall send a list of deficiencies
and the corrective action to be taken to the MBC.
12)States that if an outpatient setting does not comply with a
corrective action plan within a timeframe specified by the
accrediting agency, the accrediting agency shall issue a reprimand,
and may either place the outpatient setting on probation, suspend or
SB 100
Page 6
revoke the accreditation of an outpatient setting, and to notify the
MBC of this action. Provides that this provision shall not be
deemed to prohibit an outpatient setting that is unable to correct
the deficiencies, as specified in the plan of correction, for
reasons beyond its control, from voluntarily surrendering its
accreditation prior to initiation of any suspension or revocation
proceeding.
13)Requires an accreditation agency, within 24 hours, to report to the
MBC if an outpatient setting has been issued a reprimand or if the
outpatient setting's certification of accreditation has been
suspended or revoked or if the outpatient setting has been placed on
probation.
14)Requires an accreditation agency, upon receipt of a complaint from
the MBC that an outpatient setting poses an immediate risk to public
safety, to inspect an outpatient setting and report its findings of
inspection to the MBC within 5 business days. Provides that if an
accrediting agency receives any other complaint from the MBC, it
shall investigate the outpatient setting and report its finding of
investigation to the MBC within 30 days.
15)Requires that reports on the results of inspection to be kept on
file with the MBC and the accreditation agency along with the plan
of correction and the comments of the outpatient setting. Indicates
that the inspection report may include a recommendation for
re-inspection, and that all inspection reports, list of
deficiencies, and plans of correction are public records open to
public inspection.
16)Provides that if one accrediting agency denies accreditation, or
revokes or suspends the accreditation of an outpatient setting, this
action shall apply to all other accrediting agencies. Allows an
outpatient setting to reapply for accreditation with another
accrediting agency upon disclosure of the full accreditation report
of the accrediting agency that denied accreditation. Indicates that
any outpatient setting that has been denied accreditation shall
disclose the accreditation report to any other accrediting agency to
which it submits an application.
17)Requires that if an outpatient setting's accreditation has been
suspended, revoked, or if the accreditation has been denied, the
accreditation agency shall do all of the following: a) notify the
MBC of this action; b) send a notification letter to the outpatient
setting, and the notification letter should state that the setting
is no longer allowed to perform procedures that require outpatient
SB 100
Page 7
setting accreditation; and, c) require the outpatient setting to
remove its accreditation certification and to post the notification
letter in a conspicuous location, accessible to public view.
18)Allows the MBC to take any appropriate action it deems necessary,
as specified, if the outpatient setting's certification of
accreditation has been suspended, revoked, or if the accreditation
has been denied.
19)Requires, instead of allows, the MBC to evaluate the performance of
accrediting agencies no less than every three years, as specified.
20)Requires the MBC to investigate all complaints concerning a
violation, as specified. Requires the MBC or the local district
attorney, upon discovery that an outpatient setting is not complying
with certification requirements, to bring an action to enjoin the
outpatient setting's accreditation, as specified. States that if an
outpatient setting is operating without a certificate of
accreditation, this shall be prima facie evidence that a violation
has occurred, as specified, and additional proof shall not be
necessary to enjoin an outpatient setting's operation.
21)Clarifies that a survey does not constitute an inspection for
purposes of outpatient settings.
22)Deletes the requirement that the MBC or the accrediting agency give
reasonable prior notice and present proper identification prior to
an inspection.
FISCAL EFFECT: Unknown. This bill has been keyed "fiscal" by
Legislative Counsel.
COMMENTS:
1.Purpose. The Author is the sponsor of this measure. The Author
points out that this bill provides for greater oversight and
regulation of surgical clinics, and other types of clinics such as
fertility and outpatient settings, and ensures that quality of care
standards are in place at these clinics and checked by the
appropriate credentialing agency. In California, cosmetic surgery
can be performed by any licensed physician, and many physicians, who
may or may not be trained in cosmetic procedures are conducting
increasingly complex procedures in settings outside of hospitals
such as outpatient surgery centers and doctors' offices. The Author
points out that there is a need to improve and strengthen the
SB 100
Page 8
oversight of these outpatient clinics. For example, there is a lack
of specific requirements at the clinics dealing with pre- and
post-operative procedures, and the standards are unclear as to the
regularity of inspections. This bill will improve and ensure the
quality and effectiveness of medical procedures conducted at these
outpatient settings.
2.Background.
a) Popularity of Plastic Surgery. The number of cosmetic
procedures performed in the United States is increasing at an
alarming rate. According to the American Society of Plastic
Surgeons ' (ASPS) Website, there were 13.1 million cosmetic
surgeries performed in the United States in 2010, up 5% from
2009. The ASPS indicates that the top 5 surgical procedures were
breast augmentation, nose reshaping, eyelid surgery, liposuction,
and tummy tuck. Moreover, ASPS points out that
minimally-invasive cosmetic procedures rose to over 11.5 million
procedures in 2009. The top 5 minimally-invasive procedures were
Botox, soft tissue fillers, chemical peel, laser hair removal,
and microdermabrasion.
b) Prior Efforts Dealing with Cosmetic Surgery Practices. In
California, cosmetic surgery can be performed by any licensed
physician; from a plastic surgeon to a pediatrician. Many
physicians, who may or may not be trained in cosmetic procedures,
are conducting increasingly complex procedures in settings
outside of hospitals such as outpatient surgery centers and
doctors' offices. It is also common for doctors performing
complex cosmetic surgeries to receive their only training from
weekend courses or instructional videos. Currently, there are no
uniform standards for physician training related to cosmetic
surgery, and the regulation of outpatient settings in which these
surgeries occur need to be strengthened to ensure public safety.
The Legislature attempted to regulate the practice of cosmetic
surgery in previous years with the introduction of several bills
including:
i) SB 1423 (Figueroa, Chapter 873, Statutes of 2006) required
the MBC in conjunction with the BRN to promulgate regulations
on or before January 1, 2009 to implement changes relating to
the use of laser or intense pulse light devices for cosmetic
procedures by physicians and surgeons, nurses, and physician
assistants.
ii) SB 835 (Figueroa, 1999) would have enacted the Cosmetic
SB 100
Page 9
Surgery Patient Disclosure Act, which would have required
physicians who perform cosmetic surgery, as defined, to provide
the MBC with specified information, including training, board
certifications, and number of procedures performed, and
requires the MBC to make this information available to the
public upon request and post the information on the internet.
SB 835 was vetoed by then Governor Davis who indicated that the
methods prescribed by the measure were unduly burdensome.
iii) SB 836 (Figueroa, Chapter 856, Statutes of 1999) expanded
and revised the prohibition against fraudulent advertising by
health practitioners.
iv) SB 837 (Figueroa, 1999) would have required cosmetic
surgery procedures to be performed in a licensed acute care
hospital or in a licensed or accredited outpatient surgery
setting. SB 837 died in the Assembly Appropriations Committee.
c) Accredited Outpatient Settings vs. Licensed Surgical Clinics.
The Health and Safety Code makes a distinction between clinics
licensed by the Department of Public Health (DPH) and outpatient
settings that are accredited by an outside accrediting agency
under the oversight of the MBC. Clinics licensed by the DPH are
non-physician owned, while clinics accredited by an accreditation
agency approved by the MBC are physician owned and operated.
DPH-licensed clinics include a clinic that is not part of a
hospital and provides ambulatory surgical care for patients who
remain less than 24-hours. As part of their licensure, clinics
under DPH's jurisdiction undergo inspection and must have in
place minimum standards of safety and staffing. On the other
hand, clinics that are physician-owned and are accredited by an
accreditation agency approved by the MBC are commonly referred to
as outpatient settings. Outpatient setting is defined as a
facility where anesthesia is used in doses that when administered
does not have the probability of placing the patient at risk for
loss of the patient's life. These clinics are accredited by one
of four accreditation bodies that are approved by the MBC. These
accrediting agencies must ensure that certification programs
include standards for the operation of outpatient settings such
as safety and emergency training requirements, licensure or
certification of allied health staff, provision of onsite
equipment, medication and trained personnel in a medical
emergency, permit surgery only by a licensee who has admitting
privileges at a local accredited or licensed acute care hospital,
as defined, and a system for patient care and monitoring
procedures The four accrediting agencies approved by the MBC are
SB 100
Page 10
the American Association for Accreditation of Ambulatory Surgery
Facilities Inc., Accreditation Association for Ambulatory Health
Care, the Institute for Medical Quality and the Joint Commission.
Existing law's distinction on which clinics are licensed by the DPH
and fall under the jurisdiction of the MBC is unclear and has
been the subject of litigation. In Capen v. Shewry (2007) 147
Cal.App.4th 680, the issue before the court was whether a
surgical clinic that is wholly owned and operated by a licensed
physician, in which non-owner, non-licensee, physicians will
practice, is required to obtain a license from DPH. The facts of
the case reveal that the plaintiff, Dr. Capen, is a licensed
physician who is building a surgical clinic that he will wholly
own and operate, in which non-owner, non-licensee physicians will
practice. He was informed by DPH (then DHS) that a license is
required of the clinic because of the physicians who do not share
in its ownership and operation. Dr. Capen sued DHS and argued
that the existing law provisions governing the authority of DPH
to license facilities is ambiguous. At issue in Capen was
Section 1204 (b)(1) of the Health and Safety Code which states
that "a surgical clinic is a clinic that is not part of a
hospital and that provides ambulatory surgical care for patients
who remain less than 24 hours. A surgical clinic does not
include any place or establishment owned or leased and operated
as a clinic or office by one or more physicians or dentists in
individual or group practice, regardless of the name used
publicly to identify the place or establishment, provided;
however, that physicians or dentists may, at their option, apply
for licensure." The Court indicated that the provisions of
Section 1204(b)(1) where clinics "owned or leased by one or more
physicians in individual or group practice" was ambiguous because
it could be interpreted to require an ownership or lease interest
either by one physician in group practice or by all of the
physicians in the group. As a result, the Court held that
Section 1204(b)(1) is void since it did not follow the
Administrative Procedure Act. The Court concluded that
physician-owned-and-operated surgical clinics are not subject to
licensing by DPH and are to be regulated by the MBC. In an
effort to clarify MBC's authority over outpatient settings after
Capen, MBC submitted a letter on October 18, 2007 to Judge
Coleman Blease, who issued the opinion in the Capen case. MBC
stated that "the law does not give the MBC the authority to
regulate clinics owned and operated by physicians. It just gives
the MBC the authority to approve accrediting agencies that are in
compliance with the standards set forth in Health and Safety Code
Section 1248 et.seq."
SB 100
Page 11
d) Recent Review by the MBC, BRN and PAC of Issues Involving Use
of Certain Cosmetic Procedures. SB 1423 (Figueroa, Chapter 873,
Statutes of 2006) required the MBC in conjunction with BRN to
promulgate regulations on or before January 1, 2009 to implement
changes relating to the use of laser or intense pulse light
devices for cosmetic procedures. The MBC and the BRN have held
meetings, discussions and heard testimony from a number of
organizations representing nurses, physicians, physician
assistants, patients and the laser industry. The discussions
included recommendations on training of personnel that use laser
equipment, the appropriate level of physician supervision at
these facilities, the appropriate advertising to inform patients
of the practitioners' credentials and degrees, who should own or
control these facilities, liability and establishing standardized
procedural rules. The discussions and meetings revealed that
there is frequent disregard of the law in the use of laser or
intense pulse light devices in the treatment of patients.
Two statements were approved by both boards in these discussions;
the first outlines the responsibilities of physicians in cosmetic
procedures, including the supervision of allied health staff
performing laser procedures, and the second is a revised
statement to better inform consumers on cosmetic procedures,
currently available on MBC's Website but includes the following:
"An appropriate examination must be conducted before treatments
are performed. This exam must be conducted by a physician, or
the doctor may delegate the examination to licensed nurse
practitioners or physician assistants. Physicians may not
delegate this examination to registered nurses."
e) Assisted Reproductive Technology. This bill would include
facilities that offer in vitro fertilization in the definition of
outpatient settings. According to the Centers for Disease
Control (CDC), ART includes all fertility treatments in which
both eggs and sperm are handled. In general, ART procedures
involve surgically removing eggs from a woman's ovaries,
combining them with sperm in the laboratory, and returning them
to the woman's body or donating them to another woman. CDC
points out that of the approximately 62 million women of
reproductive age in 2002, about 1.2 million, or 2%, had an
infertility-related medical appointment within the previous year,
and 8% had an infertility-related medical visit at some point in
the past. Infertility services include medical tests to diagnose
infertility, medical advice and treatments to help a woman become
pregnant, and services other than routine prenatal care to
SB 100
Page 12
prevent miscarriage. CDC also states that the number of infants
born after ART doubled in the United States from 1996-2004, and
in 2005, more than 134,000 ART procedures were performed and
approximately 52,000 infants were born as a result of these
procedures. According to a CDC 2008 report, infants conceived
with ART are two to four times more likely to have certain types
of birth defects than children conceived naturally.
Currently, there are two organizations that physicians who practice
reproductive medicine generally belong. One is the ASRM and the
other is the Society for Reproductive Technology, an affiliate of
ASRM. Both organizations provide practice guidelines and minimum
standards regarding assisted hatching, blastocyst transfer and
gamete and embryo donation. It should be noted that the
guidelines adopted by ASRM and SART are not mandatory guidelines.
In addition, it appears that about 20% of clinics that belong to
either organizations adhere to the guidelines, and usually the
only penalty for violating the guidelines is expulsion from the
professional organization.
3.Arguments in Support. The California Medical Association (CMA)
states that this bill will enhance the safety of patients who obtain
procedures in outpatient surgery settings. The CMA states that this
bill closes gaps and adds important safeguards, and brings important
new regulatory oversight over accredited outpatient settings and
improves the ability of accrediting agencies and the MBC to ensure
that the care provided to consumers in these settings is top notch,
and that any bad actors are immediately identified and remediated or
discipline.
The California Society of Dermatology and Dermatologic Society states
that this bill protects patient safety by increasing accreditation
requirements and oversight of outpatient surgery clinics.
4.Proposed Author's Amendment. The California Hospital Association
has requested an amendment regarding the reporting of inappropriate
care at an outpatient setting from the medical staff peer review
committee of an acute care facility. It is technical in nature and
just provides that the acute care facility shall report to
accrediting body and "in accordance with existing law."
On page 24, lines 12 through 14, strike, "the Health Care Financing
Administration, the State Department of Public Health, and the
appropriate licensing authority" and insert the following:
"and accordance with existing law."
SB 100
Page 13
SUPPORT AND OPPOSITION:
Support:
California Medical Association
California Society of Dermatology and Dermatologic Society
Opposition:
None on file as of April 26, 2011
Consultant:Rosielyn Pulmano