BILL ANALYSIS �
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|SENATE RULES COMMITTEE | SB 100|
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THIRD READING
Bill No: SB 100
Author: Price (D)
Amended: 5/3/11
Vote: 21
SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE : 9-0, 5/2/11
AYES: Price, Emmerson, Corbett, Correa, Hernandez, Negrete
McLeod, Vargas, Walters, Wyland
SENATE APPROPRIATIONS COMMITTEE : 8-0, 5/26/11
AYES: Kehoe, Walters, Alquist, Lieu, Pavley, Price,
Runner, Steinberg
NO VOTE RECORDED: Emmerson
SUBJECT : Healing arts
SOURCE : Author
DIGEST : This bill 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; and revises the existing definition of
"outpatient settings" to include fertility clinics that
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offer in vitro fertilization.
ANALYSIS :
Existing law:
1. Requires the MBC in conjunction with the Board of
Registered Nursing (BRN), and in consultation with the
Physician Assistant 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 physicians and surgeons, nurses,
and physician assistants.
2. 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.
3. 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.
4. 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.
5. 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.
6. Authorizes the 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 the MBC.
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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 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
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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.
7. Requires the MBC to place the list of accredited
outpatient setting it currently maintains on its Web
site 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 three
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.
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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 three 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 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
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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 setting accreditation; and (c)
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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 : Appropriation: No Fiscal Com.: Yes
Local: Yes
According to the Senate Appropriations Committee:
Fiscal Impact (in thousands)
Major Provisions 2011-12 2012-13
2013-14 Fund
Outpatient facility up to $50
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annually Special*
* Medical Board of California Contingent Fund
SUPPORT : (Verified 5/26/11)
California Medical Association
California Society of Anesthesiologists
California Society of Dermatology and Dermatologic Society
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.
JJA:mw 5/26/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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