BILL NUMBER: SB 100 ENROLLED
BILL TEXT
PASSED THE SENATE AUGUST 30, 2011
PASSED THE ASSEMBLY AUGUST 25, 2011
AMENDED IN ASSEMBLY JULY 12, 2011
AMENDED IN ASSEMBLY JUNE 23, 2011
AMENDED IN SENATE MAY 3, 2011
AMENDED IN SENATE APRIL 25, 2011
INTRODUCED BY Senator Price
JANUARY 11, 2011
An act to amend Section 2023.5 of the Business and Professions
Code, and to amend Sections 1248, 1248.15, 1248.2, 1248.25, 1248.35,
1248.5, 1248.7, and 1248.85 of the Health and Safety Code, relating
to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
SB 100, Price. Healing arts.
(1) Existing law provides for the licensure and regulation of
various healing arts practitioners by boards under the Department of
Consumer Affairs. Existing law requires the Medical Board of
California, in conjunction with the Board of Registered Nursing, 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 their respective licensees.
This bill would require the board to adopt regulations by January
1, 2013, regarding the appropriate level of physician availability
needed within clinics or other settings using certain laser or
intense pulse light devices for elective cosmetic procedures.
(2) Existing law requires the Medical Board of California, as
successor to the Division of Licensing of the Medical Board of
California, to adopt standards for accreditation of outpatient
settings, as defined, 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. Existing law makes a willful violation of these
and other provisions relating to outpatient settings a crime.
This bill would include, among those specified aspects, the
submission for approval by an accreditation 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. This bill would, as part of the
accreditation process, authorize the accrediting agency to conduct a
reasonable investigation, as defined, of the prior history of the
outpatient setting. The bill would also modify the definition of
"outpatient setting" to include facilities that offer in vitro
fertilization, as defined. By changing the definition of a crime,
this bill would impose a state-mandated local program.
Existing law also requires the Medical Board of California 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.
This bill would, instead, require the board to obtain and maintain
the list for all accredited outpatient settings, and to notify the
public, by placing the information on its Internet Web site, whether
the 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.
Existing law requires accreditation of an outpatient setting to be
denied if the setting does not meet specified standards. Existing
law authorizes an outpatient setting to reapply for accreditation at
any time after receiving notification of the denial.
This bill would require the accreditation agency to report within
3 business days to the Medical Board of California if the outpatient
setting's certificate for accreditation has been denied. Because a
willful violation of this requirement would be a crime, the bill
would impose a state-mandated local program. The bill would also
apply the denial of accreditation, or the revocation or suspension of
accreditation by one accrediting agency, to all other accrediting
agencies.
Existing law authorizes the Medical Board of California, as
successor to the Division of Medical Quality of the Medical Board of
California, or an accreditation agency to, upon reasonable prior
notice and presentation of proper identification, enter and inspect
any accredited outpatient setting to ensure compliance with, or
investigate an alleged violation of, any standard of the
accreditation agency or any provision of the specified law.
This bill would delete the notice and identification requirements.
The bill would require that every outpatient setting that is
accredited be inspected by the accreditation agency, as specified,
and would specify that it may also be inspected by the board and the
department, as specified. The bill would require the board to ensure
that accreditation agencies inspect outpatient settings.
Existing law authorizes the Medical Board of California to
evaluate the performance of an approved accreditation agency no less
than every 3 years, or in response to complaints against an agency,
or complaints against one or more outpatient settings accreditation
by an agency that indicates noncompliance by the agency with the
standards approved by the board.
This bill would make that evaluation mandatory.
Existing law authorizes the board or the local district attorney
to bring an action to enjoin a violation or threatened violation of
the licensing provisions for outpatient settings in the superior
court in and for the county in which the violation occurred or is
about to occur.
This bill would require the board to investigate all complaints
concerning a violation of these provisions and, with respect to any
complaints relating to a violation of a specified provision, or upon
discovery that an outpatient setting is not in compliance with that
specified provision, would require the board to investigate and,
where appropriate, the board, through or in conjunction with the
local district attorney, to bring an action to enjoin the outpatient
setting's operation, as specified.
(3) The California Constitution requires the state to reimburse
local agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 2023.5 of the Business and Professions Code is
amended to read:
2023.5. (a) The board, in conjunction with the Board of
Registered Nursing, and in consultation with the Physician Assistant
Committee and professionals in the field, shall review issues and
problems surrounding the use of laser or intense light pulse devices
for elective cosmetic procedures by physicians and surgeons, nurses,
and physician assistants. The review shall include, but need not be
limited to, all of the following:
(1) The appropriate level of physician supervision needed.
(2) The appropriate level of training to ensure competency.
(3) Guidelines for standardized procedures and protocols that
address, at a minimum, all of the following:
(A) Patient selection.
(B) Patient education, instruction, and informed consent.
(C) Use of topical agents.
(D) Procedures to be followed in the event of complications or
side effects from the treatment.
(E) Procedures governing emergency and urgent care situations.
(b) On or before January 1, 2009, the board and the Board of
Registered Nursing shall 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 physician assistants.
(c) On or before January 1, 2013, the board shall 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. However, 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.
(d) Nothing in this section shall be construed to modify the
prohibition against the unlicensed practice of medicine.
SEC. 2. Section 1248 of the Health and Safety Code is amended to
read:
1248. For purposes of this chapter, the following definitions
shall apply:
(a) "Division" means the Medical Board of California. All
references in this chapter to the division, the Division of Licensing
of the Medical Board of California, or the Division of Medical
Quality shall be deemed to refer to the Medical Board of California
pursuant to Section 2002 of the Business and Professions Code.
(b) (1) "Outpatient setting" means any facility, clinic,
unlicensed clinic, center, office, or other setting that is not part
of a general acute care facility, as defined in Section 1250, and
where anesthesia, except local anesthesia or peripheral nerve blocks,
or both, is used in compliance with the community standard of
practice, in doses that, when administered have the probability of
placing a patient at risk for loss of the patient's life-preserving
protective reflexes.
(2) "Outpatient setting" also means facilities that offer in vitro
fertilization, as defined in subdivision (b) of Section 1374.55.
(3) "Outpatient setting" does not include, among other settings,
any setting where anxiolytics and analgesics are administered, when
done so in compliance with the community standard of practice, in
doses that do not have the probability of placing the patient at risk
for loss of the patient's life-preserving protective reflexes.
(c) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to
outpatient settings by the board pursuant to Sections 1248.15 and
1248.4.
SEC. 3. Section 1248.15 of the Health and Safety Code is amended
to read:
1248.15. (a) The board shall adopt standards for accreditation
and, in approving accreditation agencies to perform accreditation of
outpatient settings, shall ensure that the certification program
shall, at a minimum, include standards for the following aspects of
the settings' operations:
(1) Outpatient setting allied health staff shall be licensed or
certified to the extent required by state or federal law.
(2) (A) Outpatient settings shall have a system for facility
safety and emergency training requirements.
(B) There shall be onsite equipment, medication, and trained
personnel to facilitate handling of services sought or provided and
to facilitate handling of any medical emergency that may arise in
connection with services sought or provided.
(C) In order for procedures to be performed in an outpatient
setting as defined in Section 1248, the outpatient setting shall do
one of the following:
(i) Have a written transfer agreement with a local accredited or
licensed acute care hospital, approved by the facility's medical
staff.
(ii) Permit surgery only by a licensee who has admitting
privileges at a local accredited or licensed acute care hospital,
with the exception that licensees who may be precluded from having
admitting privileges by their professional classification or other
administrative limitations, shall have a written transfer agreement
with licensees who have admitting privileges at local accredited or
licensed acute care hospitals.
(iii) Submit for approval by an accrediting agency a detailed
procedural plan for handling medical emergencies that shall be
reviewed at the time of accreditation. No reasonable plan shall be
disapproved by the accrediting agency.
(D) In addition to the requirements imposed in subparagraph (C),
the outpatient setting shall submit for approval by an accreditation
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 and urgent
care situations. 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:
(i) Notify the individual designated by the patient to be notified
in case of an emergency.
(ii) Ensure that the mode of transfer is consistent with the
patient's medical condition.
(iii) Ensure that all relevant clinical information is documented
and accompanies the patient at the time of transfer.
(iv) Continue to provide appropriate care to the patient until the
transfer is effectuated.
(E) All physicians and surgeons transferring patients from an
outpatient setting shall agree to cooperate with the medical staff
peer review process on the transferred case, the results of which
shall be referred back to the outpatient setting, if deemed
appropriate by the medical staff peer review committee. If the
medical staff of the acute care facility determines that
inappropriate care was delivered at the outpatient setting, the acute
care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body or in accordance with existing
law.
(3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of Division 2 of the Business and
Professions Code or physician and surgeon, osteopathic physician and
surgeon, or podiatrist acting within his or her scope of practice
under Chapter 5 (commencing with Section 2000) of Division 2 of the
Business and Professions Code or the Osteopathic Initiative Act. The
outpatient setting may, in its discretion, permit anesthesia service
by a certified registered nurse anesthetist acting within his or her
scope of practice under Article 7 (commencing with Section 2825) of
Chapter 6 of Division 2 of the Business and Professions Code.
(4) Outpatient settings shall have a system for maintaining
clinical records.
(5) Outpatient settings shall have a system for patient care and
monitoring procedures.
(6) (A) Outpatient settings shall have a system for quality
assessment and improvement.
(B) Members of the medical staff and other practitioners who are
granted clinical privileges shall be professionally qualified and
appropriately credentialed for the performance of privileges granted.
The outpatient setting shall grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
(C) Clinical privileges shall be periodically reappraised by the
outpatient setting. The scope of procedures performed in the
outpatient setting shall be periodically reviewed and amended as
appropriate.
(7) Outpatient settings regulated by this chapter that have
multiple service locations shall have all of the sites inspected.
(8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
(9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
(10) Outpatient settings shall have a written discharge criteria.
(b) Outpatient settings shall have a minimum of two staff persons
on the premises, one of whom shall either be a licensed physician and
surgeon or a licensed health care professional with current
certification in advanced cardiac life support (ACLS), as long as a
patient is present who has not been discharged from supervised care.
Transfer to an unlicensed setting of a patient who does not meet the
discharge criteria adopted pursuant to paragraph (10) of subdivision
(a) shall constitute unprofessional conduct.
(c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the board to protect the public health and safety.
(d) No accreditation standard adopted or approved by the board,
and no standard included in any certification program of any
accreditation agency approved by the board, shall serve to limit the
ability of any allied health care practitioner to provide services
within his or her full scope of practice. Notwithstanding this or any
other provision of law, each outpatient setting may limit the
privileges, or determine the privileges, within the appropriate scope
of practice, that will be afforded to physicians and allied health
care practitioners who practice at the facility, in accordance with
credentialing standards established by the outpatient setting in
compliance with this chapter. Privileges may not be arbitrarily
restricted based on category of licensure.
(e) The board shall adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
(f) The board may 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 of
outpatient setting as specified in Section 1248.
(g) As part of the accreditation process, the accrediting agency
shall conduct a reasonable investigation of the prior history of the
outpatient setting, including all licensed physicians and surgeons
who have an ownership interest therein, to determine whether there
have been any adverse accreditation decisions rendered against them.
For the purposes of this section, "conducting a reasonable
investigation" means querying the Medical Board of California and the
Osteopathic Medical Board of California to ascertain if either the
outpatient setting has, or, if its owners are licensed physicians and
surgeons, if those physicians and surgeons have, been subject to an
adverse accreditation decision.
(h) An outpatient setting shall be subject to the reporting
requirements in Section 1279.1 and the penalties for failure to
report specified in Section 1280.4.
SEC. 4. Section 1248.2 of the Health and Safety Code is amended to
read:
1248.2. (a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the board under this chapter.
(b) The board shall obtain and maintain a list of accredited
outpatient settings from the information provided by the
accreditation agencies approved by the board, and shall notify the
public, by placing the information on its Internet Web site, 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.
(c) The list of outpatient settings shall include all of the
following:
(1) Name, address, and telephone number of any owners, and their
medical license numbers.
(2) Name and address of the facility.
(3) The name and telephone number of the accreditation agency.
(4) The effective and expiration dates of the accreditation.
(d) Accrediting agencies approved by the board shall notify the
board and update the board on all outpatient settings that are
accredited.
SEC. 5. Section 1248.25 of the Health and Safety Code is amended
to read:
1248.25. If an outpatient setting does not meet the standards
approved by the board, accreditation shall be denied by the
accreditation agency, which shall provide the outpatient setting
notification of the reasons for the denial. An outpatient setting may
reapply for accreditation at any time after receiving notification
of the denial. The accreditation agency shall report within three
business days to the board if the outpatient setting's certificate
for accreditation has been denied.
SEC. 6. Section 1248.35 of the Health and Safety Code is amended
to read:
1248.35. (a) Every outpatient setting which is accredited shall
be inspected by the accreditation agency and may also be inspected by
the Medical Board of California. The Medical Board of California
shall ensure that accreditation agencies inspect outpatient settings.
(b) Unless otherwise specified, the following requirements apply
to inspections described in subdivision (a).
(1) The frequency of inspection shall depend upon the type and
complexity of the outpatient setting to be inspected.
(2) Inspections shall be conducted no less often than once every
three years by the accreditation agency and as often as necessary by
the Medical Board of California to ensure the quality of care
provided.
(3) The Medical Board of California or the accreditation agency
may 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 the
accreditation agency or any provision of this chapter.
(c) If an accreditation agency determines, as a result of its
inspection, that an outpatient setting is not in compliance with the
standards under which it was approved, the accreditation agency may
do any of the following:
(1) Require correction of any identified deficiencies within a set
timeframe. Failure to comply shall result in the accrediting agency
issuing a reprimand or suspending or revoking the outpatient setting'
s accreditation.
(2) Issue a reprimand.
(3) Place the outpatient setting on probation, during which time
the setting shall successfully institute and complete a plan of
correction, approved by the board or the accreditation agency, to
correct the deficiencies.
(4) Suspend or revoke the outpatient setting's certification of
accreditation.
(d) (1) Except as is otherwise provided in this subdivision,
before suspending or revoking a certificate of accreditation under
this chapter, the accreditation agency shall provide the outpatient
setting with notice of any deficiencies and the outpatient setting
shall agree with the accreditation agency on a plan of correction
that shall give the outpatient setting reasonable time to supply
information demonstrating compliance with the standards of the
accreditation agency in compliance with this chapter, as well as the
opportunity for a hearing on the matter upon the request of the
outpatient setting. During the allotted time to correct the
deficiencies, the plan of correction, which includes the
deficiencies, shall be conspicuously posted by the outpatient setting
in a location accessible to public view. 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
board. The accreditation agency may immediately suspend the
certificate of accreditation before providing notice and an
opportunity to be heard, but only when failure to take the action may
result in imminent danger to the health of an individual. In such
cases, the accreditation agency shall provide subsequent notice and
an opportunity to be heard.
(2) If an outpatient setting does not comply with a corrective
action within a timeframe specified by the accrediting agency, the
accrediting agency shall issue a reprimand, and may either place the
outpatient setting on probation or suspend or revoke the
accreditation of the outpatient setting, and shall notify the board
of its action. This section 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.
(e) The accreditation agency shall, within 24 hours, report to the
board if the 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.
(f) The accreditation agency, upon receipt of a complaint from the
board that an outpatient setting poses an immediate risk to public
safety, shall inspect the outpatient setting and report its findings
of inspection to the board within five business days. If an
accreditation agency receives any other complaint from the board, it
shall investigate the outpatient setting and report its findings of
investigation to the board within 30 days.
(g) Reports on the results of any inspection shall be kept on file
with the board 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 reinspection. 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.
(h) 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. An outpatient setting
that is denied accreditation is permitted to reapply for
accreditation with the same accrediting agency. The outpatient
setting also may apply for accreditation from another accrediting
agency, but only if it discloses the full accreditation report of the
accrediting agency that denied accreditation. Any outpatient setting
that has been denied accreditation shall disclose the accreditation
report to any other accrediting agency to which it submits an
application. The new accrediting agency shall ensure that all
deficiencies have been corrected and conduct a new onsite inspection
consistent with the standards specified in this chapter.
(i) If an outpatient setting's certification of accreditation has
been suspended or revoked, or if the accreditation has been denied,
the accreditation agency shall do all of the following:
(1) Notify the board of the action.
(2) Send a notification letter to the outpatient setting of the
action. The notification letter shall state that the setting is no
longer allowed to perform procedures that require outpatient setting
accreditation.
(3) Require the outpatient setting to remove its accreditation
certification and to post the notification letter in a conspicuous
location, accessible to public view.
(j) The board may take any appropriate action it deems necessary
pursuant to Section 1248.7 if an outpatient setting's certification
of accreditation has been suspended or revoked, or if accreditation
has been denied.
SEC. 7. Section 1248.5 of the Health and Safety Code is amended to
read:
1248.5. The board shall evaluate the performance of an approved
accreditation agency no less than every three years, or in response
to complaints against an agency, or complaints against one or more
outpatient settings accreditation by an agency that indicates
noncompliance by the agency with the standards approved by the board.
SEC. 8. Section 1248.7 of the Health and Safety Code is amended to
read:
1248.7. (a) The board shall investigate all complaints concerning
a violation of this chapter. With respect to any complaints relating
to a violation of Section 1248.1, or upon discovery that an
outpatient setting is not in compliance with Section 1248.1, the
board shall investigate and, where appropriate, the board, through or
in conjunction with the local district attorney, shall bring an
action to enjoin the outpatient setting's operation. The board or the
local district attorney may bring an action to enjoin a violation or
threatened violation of any other provision of this chapter in the
superior court in and for the county in which the violation occurred
or is about to occur. Any proceeding under this section shall conform
to the requirements of Chapter 3 (commencing with Section 525) of
Title 7 of Part 2 of the Code of Civil Procedure, except that the
Division of Medical Quality shall not be required to allege facts
necessary to show or tending to show lack of adequate remedy at law
or irreparable damage or loss.
(b) With respect to any and all actions brought pursuant to this
section alleging an actual or threatened violation of any requirement
of this chapter, the court shall, if it finds the allegations to be
true, issue an order enjoining the person or facility from continuing
the violation. For purposes of Section 1248.1, if an outpatient
setting is operating without a certificate of accreditation, this
shall be prima facie evidence that a violation of Section 1248.1 has
occurred and additional proof shall not be necessary to enjoin the
outpatient setting's operation.
SEC. 9. Section 1248.85 of the Health and Safety Code is amended
to read:
1248.85. This chapter shall not preclude an approved
accreditation agency from adopting additional standards consistent
with Section 1248.15, establishing procedures for the conduct of
onsite inspections, selecting onsite inspectors to perform
accreditation onsite inspections, or establishing and collecting
reasonable fees for the conduct of accreditation onsite inspections.
SEC. 10. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution 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, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.