Bill Text: CA SB674 | 2009-2010 | Regular Session | Enrolled
Bill Title: Healing arts.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Vetoed) 2010-01-19 - Stricken from Senate file. [SB674 Detail]
Download: California-2009-SB674-Enrolled.html
BILL NUMBER: SB 674 ENROLLED
BILL TEXT
PASSED THE SENATE SEPTEMBER 8, 2009
PASSED THE ASSEMBLY SEPTEMBER 2, 2009
AMENDED IN ASSEMBLY AUGUST 17, 2009
AMENDED IN ASSEMBLY JULY 23, 2009
AMENDED IN SENATE JUNE 1, 2009
AMENDED IN SENATE MAY 20, 2009
AMENDED IN SENATE APRIL 28, 2009
AMENDED IN SENATE APRIL 2, 2009
INTRODUCED BY Senator Negrete McLeod
FEBRUARY 27, 2009
An act to amend Sections 651 and 2023.5 of, and to add Section
2027.5 to, the Business and Professions Code, and to amend Sections
1248, 1248.15, 1248.2, 1248.25, 1248.35, 1248.5, 1248.55, and 1279 of
the Health and Safety Code, relating to healing arts.
LEGISLATIVE COUNSEL'S DIGEST
SB 674, Negrete McLeod. Healing arts.
(1) Existing law provides for the licensure and regulation of
various healing arts practitioners and requires certain of those
practitioners to use particular designations following their names in
specified instances. Existing law provides that it is unlawful for
healing arts licensees to disseminate or cause to be disseminated any
form of public communication, as defined, containing a false,
fraudulent, misleading, or deceptive statement, claim, or image to
induce the rendering of services or the furnishing of products
relating to a professional practice or business for which he or she
is licensed. Existing law authorizes advertising by these healing
arts licensees to include certain general information. A violation of
these provisions is a misdemeanor.
This bill would require certain healing arts licensees to include
in advertisements, as defined, certain words or designations
following their names indicating the particular educational degree
they hold or healing art they practice, as specified. By changing the
definition of a crime, this bill would impose a state-mandated local
program.
(2) 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, 2011, 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.
(3) Existing law requires the Medical Board of California to post
on the Internet specified information regarding licensed physicians
and surgeons.
This bill would require the board to post on its Internet Web
site an easy-to-understand factsheet to educate the public about
cosmetic surgery and procedures, as specified.
(4) 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. The bill would also modify the definition
of "outpatient setting" to include facilities that offer in vitro
fertilization, as defined.
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 require the board, absent inquiry, to notify the
public whether a setting is accredited, certified, or licensed, or
the setting's accreditation, certification, or license 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 immediately
report 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.
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, 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
terminate approval of an accreditation agency if the agency is not
meeting the criteria set by the board.
This bill would also authorize the board to issue a citation to
the agency, including an administrative fine, in accordance with a
specified system established by the board.
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.
(5) Existing law provides for the licensure and regulation of
health facilities by the State Department of Public Health and
requires the department to periodically inspect those facilities, as
specified.
This bill would state the intent of the Legislature that the
department, as part of its periodic inspections of acute care
hospitals, inspect the peer review process utilized by those
hospitals.
(6) 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 651 of the Business and Professions Code is
amended to read:
651. (a) It is unlawful for any person licensed under this
division or under any initiative act referred to in this division to
disseminate or cause to be disseminated any form of public
communication containing a false, fraudulent, misleading, or
deceptive statement, claim, or image for the purpose of or likely to
induce, directly or indirectly, the rendering of professional
services or furnishing of products in connection with the
professional practice or business for which he or she is licensed. A
"public communication" as used in this section includes, but is not
limited to, communication by means of mail, television, radio, motion
picture, newspaper, book, list or directory of healing arts
practitioners, Internet, or other electronic communication.
(b) A false, fraudulent, misleading, or deceptive statement,
claim, or image includes a statement or claim that does any of the
following:
(1) Contains a misrepresentation of fact.
(2) Is likely to mislead or deceive because of a failure to
disclose material facts.
(3) (A) Is intended or is likely to create false or unjustified
expectations of favorable results, including the use of any
photograph or other image that does not accurately depict the results
of the procedure being advertised or that has been altered in any
manner from the image of the actual subject depicted in the
photograph or image.
(B) Use of any photograph or other image of a model without
clearly stating in a prominent location in easily readable type the
fact that the photograph or image is of a model is a violation of
subdivision (a). For purposes of this paragraph, a model is anyone
other than an actual patient, who has undergone the procedure being
advertised, of the licensee who is advertising for his or her
services.
(C) Use of any photograph or other image of an actual patient that
depicts or purports to depict the results of any procedure, or
presents "before" and "after" views of a patient, without specifying
in a prominent location in easily readable type size what procedures
were performed on that patient is a violation of subdivision (a). Any
"before" and "after" views (i) shall be comparable in presentation
so that the results are not distorted by favorable poses, lighting,
or other features of presentation, and (ii) shall contain a statement
that the same "before" and "after" results may not occur for all
patients.
(4) Relates to fees, other than a standard consultation fee or a
range of fees for specific types of services, without fully and
specifically disclosing all variables and other material factors.
(5) Contains other representations or implications that in
reasonable probability will cause an ordinarily prudent person to
misunderstand or be deceived.
(6) Makes a claim either of professional superiority or of
performing services in a superior manner, unless that claim is
relevant to the service being performed and can be substantiated with
objective scientific evidence.
(7) Makes a scientific claim that cannot be substantiated by
reliable, peer reviewed, published scientific studies.
(8) Includes any statement, endorsement, or testimonial that is
likely to mislead or deceive because of a failure to disclose
material facts.
(c) Any price advertisement shall be exact, without the use of
phrases, including, but not limited to, "as low as," "and up,"
"lowest prices," or words or phrases of similar import. Any
advertisement that refers to services, or costs for services, and
that uses words of comparison shall be based on verifiable data
substantiating the comparison. Any person so advertising shall be
prepared to provide information sufficient to establish the accuracy
of that comparison. Price advertising shall not be fraudulent,
deceitful, or misleading, including statements or advertisements of
bait, discount, premiums, gifts, or any statements of a similar
nature. In connection with price advertising, the price for each
product or service shall be clearly identifiable. The price
advertised for products shall include charges for any related
professional services, including dispensing and fitting services,
unless the advertisement specifically and clearly indicates
otherwise.
(d) Any person so licensed shall not compensate or give anything
of value to a representative of the press, radio, television, or
other communication medium in anticipation of, or in return for,
professional publicity unless the fact of compensation is made known
in that publicity.
(e) Any person so licensed may not use any professional card,
professional announcement card, office sign, letterhead, telephone
directory listing, medical list, medical directory listing, or a
similar professional notice or device if it includes a statement or
claim that is false, fraudulent, misleading, or deceptive within the
meaning of subdivision (b).
(f) Any person so licensed who violates this section is guilty of
a misdemeanor. A bona fide mistake of fact shall be a defense to this
subdivision, but only to this subdivision.
(g) Any violation of this section by a person so licensed shall
constitute good cause for revocation or suspension of his or her
license or other disciplinary action.
(h) Advertising by any person so licensed may include the
following:
(1) A statement of the name of the practitioner.
(2) A statement of addresses and telephone numbers of the offices
maintained by the practitioner.
(3) A statement of office hours regularly maintained by the
practitioner.
(4) A statement of languages, other than English, fluently spoken
by the practitioner or a person in the practitioner's office.
(5) (A) A statement that the practitioner is certified by a
private or public board or agency or a statement that the
practitioner limits his or her practice to specific fields.
(i) For the purposes of this section, a dentist licensed under
Chapter 4 (commencing with Section 1600) may not hold himself or
herself out as a specialist, or advertise membership in or specialty
recognition by an accrediting organization, unless the practitioner
has completed a specialty education program approved by the American
Dental Association and the Commission on Dental Accreditation, is
eligible for examination by a national specialty board recognized by
the American Dental Association, or is a diplomate of a national
specialty board recognized by the American Dental Association.
(ii) A dentist licensed under Chapter 4 (commencing with Section
1600) shall not represent to the public or advertise accreditation
either in a specialty area of practice or by a board not meeting the
requirements of clause (i) unless the dentist has attained membership
in or otherwise been credentialed by an accrediting organization
that is recognized by the board as a bona fide organization for that
area of dental practice. In order to be recognized by the board as a
bona fide accrediting organization for a specific area of dental
practice other than a specialty area of dentistry authorized under
clause (i), the organization shall condition membership or
credentialing of its members upon all of the following:
(I) Successful completion of a formal, full-time advanced
education program that is affiliated with or sponsored by a
university based dental school and is beyond the dental degree at a
graduate or postgraduate level.
(II) Prior didactic training and clinical experience in the
specific area of dentistry that is greater than that of other
dentists.
(III) Successful completion of oral and written examinations based
on psychometric principles.
(iii) Notwithstanding the requirements of clauses (i) and (ii), a
dentist who lacks membership in or certification, diplomate status,
other similar credentials, or completed advanced training approved as
bona fide either by an American Dental Association recognized
accrediting organization or by the board, may announce a practice
emphasis in any other area of dental practice only if the dentist
incorporates in capital letters or some other manner clearly
distinguishable from the rest of the announcement, solicitation, or
advertisement that he or she is a general dentist.
(iv) A statement of certification by a practitioner licensed under
Chapter 7 (commencing with Section 3000) shall only include a
statement that he or she is certified or eligible for certification
by a private or public board or parent association recognized by that
practitioner's licensing board.
(B) A physician and surgeon licensed under Chapter 5 (commencing
with Section 2000) by the Medical Board of California may include a
statement that he or she limits his or her practice to specific
fields, but shall not include a statement that he or she is certified
or eligible for certification by a private or public board or parent
association, including, but not limited to, a multidisciplinary
board or association, unless that board or association is (i) an
American Board of Medical Specialties member board, (ii) a board or
association with equivalent requirements approved by that physician
and surgeon's licensing board, or (iii) a board or association with
an Accreditation Council for Graduate Medical Education approved
postgraduate training program that provides complete training in that
specialty or subspecialty. A physician and surgeon licensed under
Chapter 5 (commencing with Section 2000) by the Medical Board of
California who is certified by an organization other than a board or
association referred to in clause (i), (ii), or (iii) shall not use
the term "board certified" in reference to that certification, unless
the physician and surgeon is also licensed under Chapter 4
(commencing with Section 1600) and the use of the term "board
certified" in reference to that certification is in accordance with
subparagraph (A). A physician and surgeon licensed under Chapter 5
(commencing with Section 2000) by the Medical Board of California who
is certified by a board or association referred to in clause (i),
(ii), or (iii) shall not use the term "board certified" unless the
full name of the certifying board is also used and given comparable
prominence with the term "board certified" in the statement.
For purposes of this subparagraph, a "multidisciplinary board or
association" means an educational certifying body that has a
psychometrically valid testing process, as determined by the Medical
Board of California, for certifying medical doctors and other health
care professionals that is based on the applicant's education,
training, and experience.
For purposes of the term "board certified," as used in this
subparagraph, the terms "board" and "association" mean an
organization that is an American Board of Medical Specialties member
board, an organization with equivalent requirements approved by a
physician and surgeon's licensing board, or an organization with an
Accreditation Council for Graduate Medical Education approved
postgraduate training program that provides complete training in a
specialty or subspecialty.
The Medical Board of California shall adopt regulations to
establish and collect a reasonable fee from each board or association
applying for recognition pursuant to this subparagraph. The fee
shall not exceed the cost of administering this subparagraph.
Notwithstanding Section 2 of Chapter 1660 of the Statutes of 1990,
this subparagraph shall become operative July 1, 1993. However, an
administrative agency or accrediting organization may take any action
contemplated by this subparagraph relating to the establishment or
approval of specialist requirements on and after January 1, 1991.
(C) A doctor of podiatric medicine licensed under Chapter 5
(commencing with Section 2000) by the Medical Board of California may
include a statement that he or she is certified or eligible or
qualified for certification by a private or public board or parent
association, including, but not limited to, a multidisciplinary board
or association, if that board or association meets one of the
following requirements: (i) is approved by the Council on Podiatric
Medical Education, (ii) is a board or association with equivalent
requirements approved by the California Board of Podiatric Medicine,
or (iii) is a board or association with the Council on Podiatric
Medical Education approved postgraduate training programs that
provide training in podiatric medicine and podiatric surgery. A
doctor of podiatric medicine licensed under Chapter 5 (commencing
with Section 2000) by the Medical Board of California who is
certified by a board or association referred to in clause (i), (ii),
or (iii) shall not use the term "board certified" unless the full
name of the certifying board is also used and given comparable
prominence with the term "board certified" in the statement. A doctor
of podiatric medicine licensed under Chapter 5 (commencing with
Section 2000) by the Medical Board of California who is certified by
an organization other than a board or association referred to in
clause (i), (ii), or (iii) shall not use the term "board certified"
in reference to that certification.
For purposes of this subparagraph, a "multidisciplinary board or
association" means an educational certifying body that has a
psychometrically valid testing process, as determined by the
California Board of Podiatric Medicine, for certifying doctors of
podiatric medicine that is based on the applicant's education,
training, and experience. For purposes of the term "board certified,"
as used in this subparagraph, the terms "board" and "association"
mean an organization that is a Council on Podiatric Medical Education
approved board, an organization with equivalent requirements
approved by the California Board of Podiatric Medicine, or an
organization with a Council on Podiatric Medical Education approved
postgraduate training program that provides training in podiatric
medicine and podiatric surgery.
The California Board of Podiatric Medicine shall adopt regulations
to establish and collect a reasonable fee from each board or
association applying for recognition pursuant to this subparagraph,
to be deposited in the State Treasury in the Podiatry Fund, pursuant
to Section 2499. The fee shall not exceed the cost of administering
this subparagraph.
(6) A statement that the practitioner provides services under a
specified private or public insurance plan or health care plan.
(7) A statement of names of schools and postgraduate clinical
training programs from which the practitioner has graduated, together
with the degrees received.
(8) A statement of publications authored by the practitioner.
(9) A statement of teaching positions currently or formerly held
by the practitioner, together with pertinent dates.
(10) A statement of his or her affiliations with hospitals or
clinics.
(11) A statement of the charges or fees for services or
commodities offered by the practitioner.
(12) A statement that the practitioner regularly accepts
installment payments of fees.
(13) Otherwise lawful images of a practitioner, his or her
physical facilities, or of a commodity to be advertised.
(14) A statement of the manufacturer, designer, style, make, trade
name, brand name, color, size, or type of commodities advertised.
(15) An advertisement of a registered dispensing optician may
include statements in addition to those specified in paragraphs (1)
to (14), inclusive, provided that any statement shall not violate
subdivision (a), (b), (c), or (e) or any other section of this code.
(16) A statement, or statements, providing public health
information encouraging preventative or corrective care.
(17) Any other item of factual information that is not false,
fraudulent, misleading, or likely to deceive.
(i) (1) Advertising by the following licensees shall include the
designations as follows:
(A) Advertising by a chiropractor licensed under Chapter 2
(commencing with Section 1000) shall include the designation "DC" or
the word "chiropractor" immediately following the chiropractor's
name.
(B) Advertising by a dentist licensed under Chapter 4 (commencing
with Section 1600) shall include the designation "DDS" or "DMD"
immediately following the dentist's name.
(C) Advertising by a physician and surgeon licensed under Chapter
5 (commencing with Section 2000) shall include the designation "MD"
immediately following the physician and surgeon's name.
(D) Advertising by an osteopathic physician and surgeon certified
under Article 21 (commencing with Section 2450) shall include the
designation "DO" immediately following the osteopathic physician and
surgeon's name.
(E) Advertising by a podiatrist certified under Article 22
(commencing with Section 2460) of Chapter 5 shall include the
designation "DPM" immediately following the podiatrist's name.
(F) Advertising by a registered nurse licensed under Chapter 6
(commencing with Section 2700) shall include the designation "RN"
immediately following the registered nurse's name.
(G) Advertising by a licensed vocational nurse under Chapter 6.5
(commencing with Section 2840) shall include the designation "LVN"
immediately following the licensed vocational nurse's name.
(H) Advertising by a psychologist licensed under Chapter 6.6
(commencing with Section 2900) shall include the designation "Ph.D."
immediately following the psychologist's name.
(I) Advertising by an optometrist licensed under Chapter 7
(commencing with Section 3000) shall include the applicable
designation or word described in Section 3098 immediately following
the optometrist's name.
(J) Advertising by a physician assistant licensed under Chapter
7.7 (commencing with Section 3500) shall include the designation "PA"
immediately following the physician assistant's name.
(K) Advertising by a naturopathic doctor licensed under Chapter
8.2 (commencing with Section 3610) shall include the designation "ND"
immediately following the naturopathic doctor's name. However, if
the naturopathic doctor uses the term or designation "Dr." in an
advertisement, he or she shall further identify himself by any of the
terms listed in Section 3661.
(2) For purposes of this subdivision, "advertisement" includes
communication by means of mail, television, radio, motion picture,
newspaper, book, directory, Internet, or other electronic
communication.
(3) Advertisements do not include any of the following:
(A) A medical directory released by a health care service plan or
a health insurer.
(B) A billing statement from a health care practitioner to a
patient.
(C) An appointment reminder from a health care practitioner to a
patient.
(4) This subdivision shall not apply until January 1, 2011, to any
advertisement that is published annually and prior to July 1, 2010.
(5) This subdivision shall not apply to any advertisement or
business card disseminated by a health care service plan that is
subject to the requirements of Section 1367.26 of the Health and
Safety Code.
(j) Each of the healing arts boards and examining committees
within Division 2 shall adopt appropriate regulations to enforce this
section in accordance with Chapter 3.5 (commencing with Section
11340) of Part 1 of Division 3 of Title 2 of the Government Code.
Each of the healing arts boards and committees and examining
committees within Division 2 shall, by regulation, define those
efficacious services to be advertised by businesses or professions
under their jurisdiction for the purpose of determining whether
advertisements are false or misleading. Until a definition for that
service has been issued, no advertisement for that service shall be
disseminated. However, if a definition of a service has not been
issued by a board or committee within 120 days of receipt of a
request from a licensee, all those holding the license may advertise
the service. Those boards and committees shall adopt or modify
regulations defining what services may be advertised, the manner in
which defined services may be advertised, and restricting advertising
that would promote the inappropriate or excessive use of health
services or commodities. A board or committee shall not, by
regulation, unreasonably prevent truthful, nondeceptive price or
otherwise lawful forms of advertising of services or commodities, by
either outright prohibition or imposition of onerous disclosure
requirements. However, any member of a board or committee acting in
good faith in the adoption or enforcement of any regulation shall be
deemed to be acting as an agent of the state.
(k) The Attorney General shall commence legal proceedings in the
appropriate forum to enjoin advertisements disseminated or about to
be disseminated in violation of this section and seek other
appropriate relief to enforce this section. Notwithstanding any other
provision of law, the costs of enforcing this section to the
respective licensing boards or committees may be awarded against any
licensee found to be in violation of any provision of this section.
This shall not diminish the power of district attorneys, county
counsels, or city attorneys pursuant to existing law to seek
appropriate relief.
(l) A physician and surgeon or doctor of podiatric medicine
licensed pursuant to Chapter 5 (commencing with Section 2000) by the
Medical Board of California who knowingly and intentionally violates
this section may be cited and assessed an administrative fine not to
exceed ten thousand dollars ($10,000) per event. Section 125.9 shall
govern the issuance of this citation and fine except that the fine
limitations prescribed in paragraph (3) of subdivision (b) of Section
125.9 shall not apply to a fine under this subdivision.
SEC. 2. 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, 2011, 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. 3. Section 2027.5 is added to the Business and Professions
Code, to read:
2027.5. The board shall post on its Internet Web site an
easy-to-understand factsheet to educate the public about cosmetic
surgery and procedures, including their risks. Included with the
factsheet shall be a comprehensive list of questions for patients to
ask their physician and surgeon regarding cosmetic surgery.
SEC. 4. 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. 5. 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.
(D) The outpatient setting shall 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.
(E) The outpatient setting shall submit for approval by an
accreditation agency at the time accreditation of 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 and to govern emergency and
urgent care situations.
(F) 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, the Health Care Financing
Administration, the State Department of Public Health, and the
appropriate licensing authority.
(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 governed by the same standards may elect
to have all service sites surveyed on any accreditation survey.
Organizations that do not elect to have all sites surveyed shall have
a sample, not to exceed 20 percent of all service sites, surveyed.
The actual sample size shall be determined by the board. The
accreditation agency shall determine the location of the sites to be
surveyed. Outpatient settings that have five or fewer sites shall
have at least one site surveyed. When an organization that elects to
have a sample of sites surveyed is approved for accreditation, all of
the organizations' sites shall be automatically accredited.
(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.
SEC. 6. 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 all accredited,
certified, and licensed outpatient settings from the information
provided by the accreditation, certification, and licensing agencies
approved by the board, and shall notify the public whether a setting
is accredited, certified, or licensed, or the setting's
accreditation, certification, or license has been revoked, suspended,
or placed on probation, or the setting has received a reprimand by
the accreditation agency.
SEC. 7. 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 immediately report to
the board if the outpatient setting's certificate for accreditation
has been denied.
SEC. 8. 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) Issue a reprimand.
(2) 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.
(3) Suspend or revoke the outpatient setting's certification of
accreditation.
(d) 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 center. During that allotted time, a list of deficiencies
and the plan of correction shall be conspicuously posted in a clinic
location accessible to public view. 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.
(e) If the board determines that deficiencies found during an
inspection suggests that the accreditation agency does not comply
with the standards approved by the board, the board may conduct
inspections, as described in this section, of other settings
accredited by the accreditation agency to determine if the agency is
accrediting settings in accordance with Section 1248.15.
(f) Reports on the results of any inspection conducted pursuant to
subdivision (a) shall be kept on file with the board or the
accreditation agency along with the plan of correction and the
outpatient setting comments. The inspection report may include a
recommendation for reinspection. All inspection reports, lists of
deficiencies, and plans of correction shall be public records open to
public inspection.
(g) The accreditation agency shall immediately 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.
SEC. 9. 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. 10. Section 1248.55 of the Health and Safety Code is amended
to read:
1248.55. (a) If the accreditation agency is not meeting the
criteria set by the board, the board may terminate approval of the
agency or may issue a citation to the agency in accordance with the
system established under subdivision (b).
(b) The board may establish, by regulation, a system for the
issuance of a citation to an accreditation agency that is not meeting
the criteria set by the board. This system shall meet the
requirements of Section 125.9 of the Business and Professions Code,
as applicable, except that both of the following shall apply:
(1) Failure of an agency to pay an administrative fine assessed
pursuant to a citation within 30 days of the date of the assessment,
unless the citation is being appealed, may result in the board's
termination of approval of the agency. Where a citation is not
contested and a fine is not paid, the full amount of the assessed
fine shall be added to the renewal fee established under Section
1248.6. Approval of an agency shall not be renewed without payment of
the renewal fee and fine.
(2) Administrative fines collected pursuant to the system shall be
deposited in the Outpatient Setting Fund of the Medical Board of
California established under Section 1248.6.
(c) Before terminating approval of an accreditation agency, the
board shall provide the accreditation agency with notice of any
deficiencies and reasonable time to supply information demonstrating
compliance with the requirements of this chapter, as well as the
opportunity for a hearing on the matter in compliance with Chapter 5
(commencing with Section 11500) of Part 1 of Division 3 of Title 2 of
the Government Code.
(d) (1) If approval of the accreditation agency is terminated by
the board, outpatient settings accredited by that agency shall be
notified by the board and, except as provided in paragraph (2), shall
be authorized to continue to operate for a period of 12 months in
order to seek accreditation through an approved accreditation agency,
unless the time is extended by the board for good cause.
(2) The board may require that an outpatient setting, that has
been accredited by an accreditation agency whose approval has been
terminated by the board, cease operations immediately if the board is
in possession of information indicating that continued operation
poses an imminent risk of harm to the health of an individual. In
such cases, the board shall provide the outpatient setting with
notice of its action, the reason underlying it, and a subsequent
opportunity for a hearing on the matter. An outpatient setting that
is ordered to cease operations under this paragraph may reapply for a
certificate of accreditation after six months and shall notify the
board promptly of its reapplication.
SEC. 11. Section 1279 of the Health and Safety Code is amended to
read:
1279. (a) Every health facility for which a license or special
permit has been issued shall be periodically inspected by the
department, or by another governmental entity under contract with the
department. The frequency of inspections shall vary, depending upon
the type and complexity of the health facility or special service to
be inspected, unless otherwise specified by state or federal law or
regulation. The inspection shall include participation by the
California Medical Association consistent with the manner in which it
participated in inspections, as provided in Section 1282 prior to
September 15, 1992.
(b) Except as provided in subdivision (c), inspections shall be
conducted no less than once every two years and as often as necessary
to ensure the quality of care being provided.
(c) For a health facility specified in subdivision (a), (b), or
(f) of Section 1250, inspections shall be conducted no less than once
every three years, and as often as necessary to ensure the quality
of care being provided.
(d) During the inspection, the representative or representatives
shall offer such advice and assistance to the health facility as they
deem appropriate.
(e) For acute care hospitals of 100 beds or more, the inspection
team shall include at least a physician, registered nurse, and
persons experienced in hospital administration and sanitary
inspections. During the inspection, the team shall offer advice and
assistance to the hospital as it deems appropriate.
(f) The department shall ensure that a periodic inspection
conducted pursuant to this section is not announced in advance of the
date of inspection. An inspection may be conducted jointly with
inspections by entities specified in Section 1282. However, if the
department conducts an inspection jointly with an entity specified in
Section 1282 that provides notice in advance of the periodic
inspection, the department shall conduct an additional periodic
inspection that is not announced or noticed to the health facility.
(g) Notwithstanding any other provision of law, the department
shall inspect for compliance with provisions of state law and
regulations during a state periodic inspection or at the same time as
a federal periodic inspection, including, but not limited to, an
inspection required under this section. If the department inspects
for compliance with state law and regulations at the same time as a
federal periodic inspection, the inspection shall be done consistent
with the guidance of the federal Centers for Medicare and Medicaid
Services for the federal portion of the inspection.
(h) The department shall emphasize consistency across the state
and in its district offices when conducting licensing and
certification surveys and complaint investigations, including the
selection of state or federal enforcement remedies in accordance with
Section 1423. The department may issue federal deficiencies and
recommend federal enforcement actions in those circumstances where
they provide more rigorous enforcement action.
(i) It is the intent of the Legislature that the department,
pursuant to its existing regulations, inspect the peer review process
utilized by acute care hospitals as part of its periodic inspection
of those hospitals pursuant to this section.
SEC. 12. 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.
