BILL ANALYSIS Ó
SB 100
Page 1
Date of Hearing: July 5, 2011
ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER
PROTECTION
Mary Hayashi, Chair
SB 100 (Price) - As Amended: June 23, 2011
SENATE VOTE : 38-0
SUBJECT : Healing arts.
SUMMARY : Requires the Medical Board of California to make a
number of changes regarding the approval, oversight and
inspection of outpatient settings and accreditation agencies and
in developing a plan of corrective action for any deficiencies
found by the accreditation agencies or the MBC during
inspections, or otherwise, and revises the existing definition
of "outpatient settings" to include fertility clinics that offer
in vitro fertilization. Specifically, this bill :
1)Requires the Medical Board of California (MBC), on or before
January 1, 2013, to adopt regulations regarding the
appropriate level of physician availability needed within
clinics or other settings using laser or intense pulse light
devices for elective cosmetic procedures. These regulations
shall 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 nor shall be construed
to modify the prohibition against the unlicensed practice of
medicine.
2)Adds facilities that offer in vitro fertilization, as defined,
to the definition of "outpatient setting."
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:
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a) Notify the individual designated by the patient to be
notified in case of an 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
under the transfer is effectuated.
4)Requires outpatient setting with multiple service locations to
have all sites inspected.
5)Requires MBC to adopt standards it deems necessary for
outpatient settings that offer in vitro fertilization.
6)Authorizes 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.
7)Requires the accrediting agency, as part of the accreditation
process, to conduct a reasonable investigation, as defined, 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.
8)Requires an outpatient setting to comply with existing adverse
event reporting requirements and penalties that apply to
health facilities.
9)Requires MBC to notify the public, by placing information on
its website, whether an outpatient setting is accredited or
the setting's accreditation has been revoked, suspended, or
placed on probation, or the setting has received a reprimand
by the accreditation agency and requires the list of
outpatient settings to include all of the following:
a) Name, address, and telephone number of any owners and
their medical license numbers;
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b) Name and address of the facility;
c) Name and telephone number of the accrediting agency;
and,
d) The effective and expiration dates of the accreditation.
10)Requires accrediting agencies approved by MBC to notify and
update MBC on all outpatient settings that have been
accredited.
11)Requires the accreditation agency to report to MBC, within 3
business days, if the outpatient setting's certificate for
accreditation has been denied.
12)Requires the accreditation agency and authorizes MBC to
inspect every accredited outpatient setting. The frequency of
inspection shall depend upon the type and complexity of the
outpatient setting to be inspected and the inspection shall be
conducted no less than once every three years by the
accreditation agency and as often as necessary by MBC to
ensure the quality of care provided.
13)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. Failure to
comply shall result in the accrediting agency issuing a
reprimand, suspending, or revoking the outpatient setting's
accreditation.
14)Requires that prior to suspending or revoking a certificate
of accreditation, an outpatient setting agree with the
accreditation agency on a plan of correction, which includes
the deficiencies and shall be conspicuously posted in a
location accessible to public view.
15)Requires the accrediting agency, within 10 days after the
adoption of the plan of correction, send a list of
deficiencies and the corrective action to be taken to MBC.
16)Requires the accrediting agency to issue a reprimand if an
outpatient setting does not comply with a corrective action
plan within a timeframe specified by the accrediting agency,
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to either place the outpatient setting on probation or suspend
or revoke the accreditation, and to notify MBC. This 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.
17)Requires an accreditation agency, within 24 hours, to report
to 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.
18)Requires an accreditation agency, upon receipt of a complaint
from MBC that an outpatient setting poses an immediate risk to
public safety, to inspect an outpatient setting and report its
findings of inspection to MBC within 5 business days. If an
accrediting agency receives any other complaint from MBC, it
shall investigate the outpatient setting and report its
finding of investigation to MBC within 30 days.
19)Requires that reports on the results of inspection to be kept
on file with MBC and the accreditation agency along with the
plan of correction and the comments of the outpatient setting.
The inspection report may include a recommendation for
re-inspection. All inspection reports, list of deficiencies,
and plans of correction are public records open to public
inspection.
20)Applies the denial or revocation or suspension of an
outpatient setting's accreditation by one accrediting agency
to all other accrediting agencies.
21)Authorizes an outpatient setting to reapply for accreditation
with the same accrediting agency or with another accrediting
agency upon disclosure of the full accreditation report of the
accrediting agency that denied accreditation. The new
accrediting agency shall ensure that all deficiencies have
been corrected and conduct a new onsite inspection consistent
with standards, as specified.
22)Requires the accreditation agency, if an outpatient setting's
accreditation has been suspended, revoked, or if the
accreditation has been denied, do all of the following:
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a) Notify MBC of the action;
b) Send a notification letter to the outpatient setting of
the action, which states that the setting is no longer
allowed to perform procedures that require outpatient
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.
23)Authorizes 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.
24)Requires MBC to evaluate the performance of accrediting
agencies no less than every three years, as specified.
25)Requires MBC to investigate all complaints concerning a
violation, as specified.
26)Requires 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. 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.
27)Deletes the requirement that MBC or the accrediting agency
give reasonable prior notice and present proper identification
prior to an inspection.
EXISTING LAW
1)Provides for the licensure and regulation of various healing
arts practitioners by boards under the Department of Consumer
Affairs.
2)Requires MBC, in conjunction with the Board of Registered
Nursing, and in consultation with the Physician Assistant
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Committee 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 their respective
licensees.
3)Requires MBC to adopt standards for accreditation of
outpatient settings and, in approving accreditation agencies
to perform this accreditation, to ensure that the
certification program shall, at a minimum, include standards
for specified aspects of the settings' operations.
4)Requires 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 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 MBC to evaluate the performance of an approved
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 MBC.
8)Requires the accrediting agency, before suspending or revoking
a certificate of accreditation, 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.
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9)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.
10)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.
11)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.
FISCAL EFFECT : Unknown
COMMENTS :
Purpose of the bill . According to the author's office, "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. 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.
"SB 100 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."
Background . Cosmetic surgery is gaining in popularity. The
American Society of Plastic Surgeons' Web site states that
approximately 13.1 million cosmetic procedures were performed in
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2010, representing a $10.1 billion industry.
Most cosmetic procedures occur in physician-owned clinics.
These clinics are accredited by one of four accreditation
agencies approved by the MBC (the American Association for
Accreditation of Ambulatory Surgery Facilities Inc.,
Accreditation Association for Ambulatory Health Care, the
Institute for Medical Quality or the Joint Commission) and are
commonly referred to as settings. A 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 life. These accrediting agencies
ensure that certification programs include standards for the
operation of settings, such as safety and emergency training
requirements, licensure or certification of allied health staff,
provision of onsite equipment, and medication and trained
personnel in a medical emergency. Settings permit surgery only
by a licensee who has admitting privileges at a local accredited
or licensed acute care hospital and require a system for patient
care and monitoring procedures.
Currently there are two organizations (the American Society of
Reproductive Medicine and the Society for Reproductive
Technology) to which physicians who practice reproductive
medicine generally belong. Both organizations provide practice
guidelines and minimum standards for assisted reproductive
technologies, including in vitro procedures. However, those
guidelines are not mandatory.
Previous legislation . SB 1150 (Negrete McLeod) of 2010 required
license designations on health care provider advertising,
required MBC to adopt regulations regarding the appropriate
level of physician availability needed within clinics or other
settings using laser or intense pulse light devices, required
MBC to post a factsheet on cosmetic surgery, required MBC to
adopt standards for settings that offer in vitro fertilization,
and made changes to MBC oversight of accreditation agencies.
This bill died in the Assembly Appropriations Committee.
SB 674 (Negrete McLeod) of 2009 required a health care
practitioner, as specified, include specific professional
designation following the health care practitioner's name in
advertisements; required the MBC to adopt regulations on the
appropriate level of physician availability necessary within
clinics or other settings using laser or intense pulse light
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devices for elective cosmetic surgery; required certain
healing arts licensees to include in advertisements certain
words or designations following their names indicating the
particular educational degree they hold or healing art they
practice, as specified; and, authorized the MBC to issue an
accreditation agency a citation, including an administrative
fine, in accordance with a specified system established by
the MBC if the agency is not meeting the criteria set by the
MBC.
This bill was vetoed by the Governor, who stated, "While some
provisions may provide marginal improvements to consumer
protection, I cannot support this bill when it fails to
address the need for stronger licensing and oversight of
outpatient surgical centers. The continued reliance by the
medical community on external accreditation agencies without
enforcement capability is an insufficient solution for
protecting patients. As outpatient surgeries continue to
increase in number and complexity, surgical centers cannot
continue to perform procedures in an unregulated and
unenforced environment."
REGISTERED SUPPORT / OPPOSITION :
Support
California Medical Association
California Society of Anesthesiologists
California Society of Dermatology and Dermatologic Surgery
Opposition
None on file.
Analysis Prepared by : Marina Wiant / B.,P. & C.P. / (916)
319-3301