BILL ANALYSIS �
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UNFINISHED BUSINESS
Bill No: SB 100
Author: Price (D)
Amended: 7/12/11
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
SENATE FLOOR : 38-0, 6/1/11
AYES: Alquist, Anderson, Berryhill, Blakeslee, Calderon,
Cannella, Corbett, De Le�n, DeSaulnier, Dutton, Evans,
Fuller, Gaines, Hancock, Harman, Hernandez, Huff, Kehoe,
La Malfa, Leno, Lieu, Liu, Lowenthal, Negrete McLeod,
Padilla, Pavley, Price, Rubio, Runner, Simitian,
Steinberg, Strickland, Vargas, Walters, Wolk, Wright,
Wyland, Yee
NO VOTE RECORDED: Correa, Emmerson
ASSEMBLY FLOOR : 78-0, 8/25/11 (Consent) - See last page
for vote
SUBJECT : Healing arts
SOURCE : Author
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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
offer in vitro fertilization.
Assembly Amendments (1) require all outpatient setting with
multiple service locations to have all sites inspected, (2)
provide that all final inspection reports, which include
the lists of deficiencies, plans of correction or
requirements for improvements and correction, and
corrective action completed, shall be public records open
to public inspection, and (3) require, when an accrediting
agency denies an accreditation and the outpatient setting
applies to a different accrediting agency, the new
accrediting agency ensure that all previous deficiencies
have been corrected and conduct a new onsite inspection.
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.
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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.
This bill:
1. Requires 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/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
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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 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.
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
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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.
B. Name and address of the facility.
C. Name and telephone number of the accrediting
agency.
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 three 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
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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, 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 five 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
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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:
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.
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.
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25.Requires MBC to investigate all complaints concerning a
violation, as specified.
26.Requires MBC, upon discovery that an outpatient setting
is not complying with certification requirements to
investigate and, where appropriate, the MBC, through or
in conjunction with the local district attorney shall
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.
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
annually Special*
* Medical Board of California Contingent Fund
SUPPORT : (Verified 8/24/11)
California Medical Association
California Society of Anesthesiologists
California Society of Dermatology and Dermatologic Society
Medical Board of California
ARGUMENTS IN SUPPORT : The California Medical Association
(CMA) states that this bill will enhance the safety of
patients who obtain procedures in outpatient surgery
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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.
ASSEMBLY FLOOR : 78-0, 8/25/11
AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Beall,
Bill Berryhill, Block, Blumenfield, Bradford, Brownley,
Buchanan, Butler, Charles Calderon, Campos, Carter,
Cedillo, Chesbro, Conway, Cook, Davis, Dickinson,
Donnelly, Eng, Feuer, Fletcher, Fong, Fuentes, Furutani,
Beth Gaines, Galgiani, Garrick, Gatto, Gordon, Grove,
Hagman, Halderman, Hall, Harkey, Hayashi, Roger
Hern�ndez, Hill, Huber, Hueso, Huffman, Jeffries, Jones,
Knight, Lara, Logue, Bonnie Lowenthal, Ma, Mansoor,
Mendoza, Miller, Mitchell, Monning, Morrell, Nestande,
Nielsen, Norby, Olsen, Pan, Perea, V. Manuel P�rez,
Portantino, Silva, Skinner, Smyth, Solorio, Swanson,
Torres, Valadao, Wagner, Wieckowski, Williams, Yamada,
John A. P�rez
NO VOTE RECORDED: Bonilla, Gorell
JJA:mw 8/26/11 Senate Floor Analyses
SUPPORT/OPPOSITION: SEE ABOVE
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