Bill Text: CA AB832 | 2009-2010 | Regular Session | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Ambulatory surgical clinics: workgroup.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced - Dead) 2010-02-02 - From committee: Filed with the Chief Clerk pursuant to Joint Rule 56. [AB832 Detail]

Download: California-2009-AB832-Introduced.html

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BILL NUMBER: AB 832	INTRODUCED
	BILL TEXT


INTRODUCED BY   Assembly Member Jones

                        FEBRUARY 26, 2009

   An act to amend Sections 1200, 1204, 1206, and 1248.1 of, and to
add Sections 1204.6, 1212.5, 1212.6, and 1212.7 to, the Health and
Safety Code, relating to public health.


	LEGISLATIVE COUNSEL'S DIGEST


   AB 832, as introduced, Jones. Clinic licensing.
   (1) Existing law establishes various programs for the prevention
of disease and the promotion of the public health under the
jurisdiction of the State Department of Public Health, including, but
not limited to, provisions for the licensing, with certain
exceptions, of clinics, as defined. A violation of these provisions
is a crime.
   This bill would exclude a place, establishment, or institution
that solely provides immunizations, or screenings for blood pressure,
cholesterol, or bone density, or a combination of those services,
from the definition of "clinic" for these purposes.
   (2) Existing law defines "surgical clinic" as a clinic that
provides ambulatory surgical care and is not part of a hospital or is
a place that is owned, leased, or operated as a clinic or office by
one or more physicians or dentists.
   This bill would recast that definition, would define "ambulatory
surgical care" for this purpose, and would delete the exemption for a
place that is owned, leased, or operated by one or more physicians
or dentists. The bill would require surgical clinics to be licensed
regardless of physician ownership, but would exclude a doctor's
office or other place that provides only prescribed services, and
would make conforming changes.
   This bill would require any person seeking licensure as a surgical
clinic to provide documentation of satisfactory completion of
prescribed structural building requirements.
   By changing the definition of an existing crime, this bill would
impose a state-mandated local program.
   This bill would declare the intent of the Legislature to
subsequently appropriate funds to the department as a loan to support
the licensing and certification program relating to surgical
clinics.
   (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.
   Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  This act shall be known, and may be cited, as the
California Outpatient Surgery Patient Safety and Improvement Act.
  SEC. 2.  Section 1200 of the Health and Safety Code is amended to
read:
   1200.  As used in this chapter, "clinic" means an organized
outpatient health facility  which   that 
provides direct medical, surgical, dental, optometric, or podiatric
advice, services, or treatment to patients who remain less than 24
hours, and which may also provide diagnostic or therapeutic services
to patients in the home as an incident to care provided at the clinic
facility. Nothing in this section shall be construed to prohibit the
provision of nursing services in a clinic licensed pursuant to this
chapter. In no case shall a clinic be deemed to be a health facility
subject to the provisions of Chapter 2 (commencing with Section 1250)
of this division. A place, establishment, or institution 
which   that  solely provides advice, counseling,
information, or referrals on the maintenance of health or on the
means and measures to prevent or avoid sickness, disease, or injury,
where such advice, counseling, information, or referrals does not
constitute the practice of medicine, surgery, dentistry, optometry,
or podiatry, shall not be deemed a clinic for purposes of this
chapter.  A place, establishment, or institution that solely
provides immunizations, or screenings for blood pressure,
cholesterol, or bone density, or any combination of these services,
shall not be deemed a clinic for purposes of this chapter. 
   References in this chapter to "primary care clinics" shall mean
and designate all the types of clinics specified in subdivision (a)
of Section 1204, including community clinics and free clinics.
References in this chapter to specialty clinics shall mean and
designate all the types of clinics specified in subdivision (b) of
Section 1204, including surgical clinics, chronic dialysis clinics,
and rehabilitation clinics.
  SEC. 3.  Section 1204 of the Health and Safety Code is amended to
read:
   1204.  Clinics eligible for licensure pursuant to this chapter are
primary care clinics and specialty clinics.
   (a) (1) Only the following defined classes of primary care clinics
shall be eligible for licensure:
   (A) A "community clinic" means a clinic operated by a tax-exempt
nonprofit corporation that is supported and maintained in whole or in
part by donations, bequests, gifts, grants, government funds or
contributions, that may be in the form of money, goods, or services.
In a community clinic, any charges to the patient shall be based on
the patient's ability to pay, utilizing a sliding fee scale. No
corporation other than a nonprofit corporation, exempt from federal
income taxation under paragraph (3) of subsection (c) of Section 501
of the Internal Revenue Code of 1954 as amended, or a statutory
successor thereof, shall operate a community clinic; provided, that
the licensee of any community clinic so licensed on the effective
date of this section shall not be required to obtain tax-exempt
status under either federal or state law in order to be eligible for,
or as a condition of, renewal of its license. No natural person or
persons shall operate a community clinic.
   (B) A "free clinic" means a clinic operated by a tax-exempt,
nonprofit corporation supported in whole or in part by voluntary
donations, bequests, gifts, grants, government funds or
contributions, that may be in the form of money, goods, or services.
In a free clinic there shall be no charges directly to the patient
for services rendered or for drugs, medicines, appliances, or
apparatuses furnished. No corporation other than a nonprofit
corporation exempt from federal income taxation under paragraph (3)
of subsection (c) of Section 501 of the Internal Revenue Code of 1954
as amended, or a statutory successor thereof, shall operate a free
clinic; provided, that the licensee of any free clinic so licensed on
the effective date of this section shall not be required to obtain
tax-exempt status under either federal or state law in order to be
eligible for, or as a condition of, renewal of its license. No
natural person or persons shall operate a free clinic.
   (2) Nothing in this subdivision shall prohibit a community clinic
or a free clinic from providing services to patients whose services
are reimbursed by third-party payers, or from entering into managed
care contracts for services provided to private or public health plan
subscribers, as long as the clinic meets the requirements identified
in subparagraphs (A) and (B). For purposes of this subdivision, any
payments made to a community clinic by a third-party payer,
including, but not limited to, a health care service plan, shall not
constitute a charge to the patient. This paragraph is a clarification
of existing law.
   (b) The following types of specialty clinics shall be eligible for
licensure as specialty clinics pursuant to this chapter:
   (1) A "surgical clinic" means a clinic that is not part of a
hospital  or a primary care clinic that is either licensed
pursuant to this section   , or exempt pursuant to
subdivision (b) of Section 1206,  and that provides ambulatory
surgical care  as defined in Section 1204.6  for patients
who remain less than 24 hours.  A surgical clinic does not
include any place or establishment owned or leased and operated as a
clinic or office by one or more physicians or dentists in individual
or group practice, regardless of the name used publicly to identify
the place or establishment, provided, however, that physicians or
dentists may, at their option, apply for licensure.  
Surgical clinics shall be subject to licensure by the department
regardless of physician ownership. 
   (2) A "chronic dialysis clinic" means a clinic that provides less
than 24-hour care for the treatment of patients with end-stage renal
disease, including renal dialysis services.
   (3) A "rehabilitation clinic" means a clinic that, in addition to
providing medical services directly, also provides physical
rehabilitation services for patients who remain less than 24 hours.
Rehabilitation clinics shall provide at least two of the following
rehabilitation services: physical therapy, occupational therapy,
social, speech pathology, and audiology services. A rehabilitation
clinic does not include the offices of a private physician in
individual or group practice.
   (4) An "alternative birth center" means a clinic that is not part
of a hospital and that provides comprehensive perinatal services and
delivery care to pregnant women who remain less than 24 hours at the
facility. 
   (c) In accordance with subdivision (d) of Section 1248.1,
licensure as a surgical clinic shall satisfy the requirements of
Chapter 1.3 (commencing with Section 1248). 
  SEC. 4.  Section 1204.6 is added to the Health and Safety Code, to
read:
   1204.6.  (a) "Ambulatory surgical care" for purposes of licensure
as a surgical clinic, means the incision, partial or complete
excision, destruction, resection, or other structural alteration of
human tissue by any means except any of the following:
   (1) Minor skin repair procedures, including, but not limited to,
any of the following:
   (A) Repair of minor lacerations.
   (B) Excision of moles, warts, or other minor skin lesions.
   (C) Incision and drainage of superficial abscesses.
   (2) Procedures using only local anesthesia, topical anesthesia, or
no anesthesia.
   (3) Procedures not using general anesthesia or conscious sedation.

   (b) "General anesthesia" for purposes of licensure as a surgical
clinic, means a controlled state of depressed consciousness or
unconsciousness, accompanied by partial or complete loss of
protective reflexes, produced by a pharmacologic or nonpharmacologic
method, or a combination thereof.
   (c) "Conscious sedation" for purposes of licensure as a surgical
clinic, means a minimally depressed level of consciousness produced
by a pharmacologic or nonpharmacologic method, or a combination
thereof, that retains the patient's ability to maintain independently
and continuously an airway, and respond appropriately to physical
stimulation or verbal command. Conscious sedation does not include
the administration of oral medications or the administration of a
mixture of nitrous oxide and oxygen, whether administered alone or in
combination with each other.
   (d) A doctor's office or other place, establishment, or
institution that provides no surgical services other than those
described in paragraphs (1), (2), and (3) of subdivision (a) shall
not be required to obtain licensure as a surgical clinic.
  SEC. 5.  Section 1206 of the Health and Safety Code is amended to
read:
   1206.   This   The licensure and other
requirements of this  chapter  does   do
 not apply to  any of  the following:
   (a)  Except with respect to the option provided with
regard to surgical clinics in paragraph (1) of subdivision (b) of
Section 1204 and, further, with respect to specialty clinics
specified in paragraph (2) of subdivision (b) of Section 1204, any
  Any    place or establishment owned or
leased and operated as a clinic or office by one or more licensed
health care practitioners and used  by the practitioner  as
an office for the practice of  their   his or
her  profession, within the scope of  their 
 his or her  license  in any lawful form of
organization, so long as each licensed health care practitioner who
practices at the clinic has some ownership or leasehold interest in,
and some degree of control over and responsibility for   ,
the operation of the clinic  , regardless of the name used
publicly to identify the place or establishment.  The exemption
pursuant to this subdivision shall not apply to either of the
following:  
   (1) Any surgical clinic as described in paragraph (1) of
subdivision (b) of Section 1204, regardless of any health care
practitioner ownership interest in the clinic.  
   (2) Any chronic dialysis clinic as described in paragraph (2) of
subdivision (b) of Section 1204. 
   (b) Any clinic directly conducted, maintained, or operated by the
United States or by any of its departments, officers, or agencies,
and any primary care clinic specified in subdivision (a) of Section
1204 that is directly conducted, maintained, or operated by this
state or by any of its political subdivisions or districts, or by any
city. Nothing in this subdivision precludes the state department
from adopting regulations that utilize clinic licensing standards as
eligibility criteria for participation in programs funded wholly or
partially under Title XVIII or XIX of the federal Social Security
Act.
   (c) Any clinic conducted, maintained, or operated by a federally
recognized Indian tribe or tribal organization, as defined in Section
450 or 1601 of Title 25 of the United States Code, that is located
on land recognized as tribal land by the federal government.
   (d) Clinics conducted, operated, or maintained as outpatient
departments of hospitals.
   (e) Any facility licensed as a health facility under Chapter 2
(commencing with Section 1250).
   (f) Any freestanding clinical or pathological laboratory licensed
under Chapter 3 (commencing with Section 1200) of Division 2 of the
Business and Professions Code.
   (g) A clinic operated by, or affiliated with, any institution of
learning that teaches a recognized healing art and is approved by the
state board or commission vested with responsibility for regulation
of the practice of that healing art.  The exemption pursuant to
this subdivision shall not apply to any surgical clinic as described
in paragraph (1) of subdivision (b) of Section 1204. 
   (h) A clinic that is operated by a primary care community or free
clinic and that is operated on separate premises from the licensed
clinic and is only open for limited services of no more than 20 hours
a week. An intermittent clinic as described in this subdivision
shall, however, meet all other requirements of law, including
administrative regulations and requirements, pertaining to fire and
life safety.
   (i) The offices of physicians in group practice who provide a
preponderance of their services to members of a comprehensive group
practice prepayment health care service plan subject to Chapter 2.2
(commencing with Section 1340).
   (j) Student health centers operated by public institutions of
higher education.
   (k) Nonprofit speech and hearing centers, as defined in Section
1201.5. Any nonprofit speech and hearing clinic desiring an exemption
under this subdivision shall make application therefor to the
director, who shall grant the exemption to any facility meeting the
criteria of Section 1201.5. Notwithstanding the licensure exemption
contained in this subdivision, a nonprofit speech and hearing center
shall be deemed to be an organized outpatient clinic for purposes of
qualifying for reimbursement as a rehabilitation center under the
Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of
Division 9 of the Welfare and Institutions Code).
   (l) A clinic operated by a nonprofit corporation exempt from
federal income taxation under paragraph (3) of subsection (c) of
Section 501 of the Internal Revenue Code of 1954, as amended, or a
statutory successor thereof, that conducts medical research and
health education and provides health care to its patients through a
group of 40 or more physicians and surgeons, who are independent
contractors representing not less than 10 board-certified
specialties, and not less than two-thirds of whom practice on a
full-time basis at the clinic.
   (m) Any clinic, limited to in vivo diagnostic services by magnetic
resonance imaging functions or radiological services under the
direct and immediate supervision of a physician and surgeon who is
licensed to practice in California. This shall not be construed to
permit cardiac catheterization or any treatment modality in these
clinics.
   (n) A clinic operated by an employer or jointly by two or more
employers for their employees only, or by a group of employees, or
jointly by employees and employers, without profit to the operators
thereof or to any other person, for the prevention and treatment of
accidental injuries to, and the care of the health of, the employees
comprising the group.
   (o) A community mental health center, as defined in Section 5601.5
of the Welfare and Institutions Code.
   (p) (1) A clinic operated by a nonprofit corporation exempt from
federal income taxation under paragraph (3) of subsection (c) of
Section 501 of the Internal Revenue Code of 1954, as amended, or a
statutory successor thereof, as an entity organized and operated
exclusively for scientific and charitable purposes and that satisfied
all of the following requirements on or before January 1, 2005:
   (A) Commenced conducting medical research on or before January 1,
1982, and continues to conduct medical research.
   (B) Conducted research in, among other areas, prostatic cancer,
cardiovascular disease, electronic neural prosthetic devices,
biological effects and medical uses of lasers, and human magnetic
resonance imaging and spectroscopy.
   (C) Sponsored publication of at least 200 medical research
articles in peer-reviewed publications.
   (D) Received grants and contracts from the National Institutes of
Health.
   (E) Held and licensed patents on medical technology.
   (F) Received charitable contributions and bequests totaling at
least five million dollars ($5,000,000).
   (G) Provides health care services to patients only:
   (i) In conjunction with research being conducted on procedures or
applications not approved or only partially approved for payment (I)
under the Medicare program pursuant to Section 1359y(a)(1)(A) of
Title 42 of the United States Code, or (II) by a health care service
plan registered under Chapter 2.2 (commencing with Section 1340), or
a disability insurer regulated under Chapter 1 (commencing with
Section 10110) of Part 2 of Division 2 of the Insurance Code;
provided that services may be provided by the clinic for an
additional period of up to three years following the approvals, but
only to the extent necessary to maintain clinical expertise in the
procedure or application for purposes of actively providing training
in the procedure or application for physicians and surgeons unrelated
to the clinic.
   (ii) Through physicians and surgeons who, in the aggregate, devote
no more than 30 percent of their professional time for the entity
operating the clinic, on an annual basis, to direct patient care
activities for which charges for professional services are paid.
   (H) Makes available to the public the general results of its
research activities on at least an annual basis, subject to good
faith protection of proprietary rights in its intellectual property.
   (I) Is a freestanding clinic, whose operations under this
subdivision are not conducted in conjunction with any affiliated or
associated health clinic or facility defined under this division,
except a clinic exempt from licensure under subdivision (m). For
purposes of this subparagraph, a freestanding clinic is defined as
"affiliated" only if it directly, or indirectly through one or more
intermediaries, controls, or is controlled by, or is under common
control with, a clinic or health facility defined under this
division, except a clinic exempt from licensure under subdivision
(m). For purposes of this subparagraph, a freestanding clinic is
defined as "associated" only if more than 20 percent of the directors
or trustees of the clinic are also the directors or trustees of any
individual clinic or health facility defined under this division,
except a clinic exempt from licensure under subdivision (m). Any
activity by a clinic under this subdivision in connection with an
affiliated or associated entity shall fully comply with the
requirements of this subdivision. This subparagraph shall not apply
to agreements between a clinic and any entity for purposes of
coordinating medical research.
   (2) By January 1, 2007, and every five years thereafter, the
Legislature shall receive a report from each clinic meeting the
criteria of this subdivision and any other interested party
concerning the operation of the clinic's activities. The report shall
include, but not be limited to, an evaluation of how the clinic
impacted competition in the relevant health care market, and a
detailed description of the clinic's research results and the level
of acceptance by the payer community of the procedures performed at
the clinic. The report shall also include a description of procedures
performed both in clinics governed by this subdivision and those
performed in other settings. The cost of preparing the reports shall
be borne by the clinics that are required to submit them to the
Legislature pursuant to this paragraph.
  SEC. 6.  Section 1212.5 is added to the Health and Safety Code, to
read:
   1212.5.  (a) Commencing January 1, 2010, in addition to other
licensing requirements of this chapter, any person, firm,
association, partnership, or corporation seeking a license for a
surgical clinic shall provide the department with documentation of
satisfactory completion of the structural and building requirements
set forth in Section 1226 of Title 24 of the California Code of
Regulations, or compliance with the 2000 Medicare Life and Safety
Code requirements.
   (b) Commencing January 1, 2010, a surgical clinic shall also meet
all of the following standards:
   (1) Only those patients who have given full informed consent about
the inherent risks of receiving surgery in facilities with limited
post surgical rescue potential that would be available in a general
acute care hospital shall receive services in the surgical clinic.
   (2) Comply with the conditions of coverage as set forth in Subpart
C of Part 416 of Title 42 of the Code of Federal Regulations, as
those conditions exist on January 1, 2008. The conditions of coverage
shall be conditions of providing services regardless of the source
of payment for those services.
   (3) Limit surgical procedures to those that comply with all of the
following:
   (A) Do not require the presence of more than one surgeon during
the procedure.
   (B) Are not expected to require a blood transfusion.
   (C) Are not expected to require major or prolonged invasion of
body cavities.
   (D) Are not expected to involve major blood vessels.
    (E) Are not inherently life threatening.
   (F) Are not emergency surgeries.
   (G) Are not experimental surgeries.
   (4) A preanesthesia evaluation, including an ASA Physical Status
Classification, shall be completed on all surgical anesthesia
patients. Surgical procedures shall not be performed on a patient
with severe systemic disease that is a constant threat to life (ASA
Classification 4) or on a moribund patient who is not expected to
survive for 24 hours without the operation (ASA Classification 5). A
patient with severe systemic disease (ASA Classification 3) shall
have a presurgical consultation with a physician specialist
appropriate for the patient's severe systemic disease in order to
obtain medical clearance for surgery.
   (5) Establish and implement policies and procedures compliant with
the conditions of coverage. The policies and procedures shall comply
with both of the following:
   (A) The policies and procedures shall include, but need not be
limited to, all of the following:
    (i) Surgical services, as provided by physicians, dentists, or
podiatrists.
   (ii) Anesthesia services.
    (iii) Nursing services.
   (iv) Evaluation of quality assessment and performance improvement.

   (v) Infection control.
   (vi) Pharmaceutical services.
   (vii) Laboratory and radiology services.
   (viii) Housekeeping services, including provisions for maintenance
of a safe, clean environment.
   (ix) Patient health records, including provisions that shall be
developed with the assistance of a person skilled in record
maintenance and preservation.
   (x) Personnel policies and procedures.
   (B) The policies and procedures shall provide for appropriate
staffing ratios for all care provided to patients receiving general
anesthesia in compliance with both of the following:
   (i) In each surgical room there shall be at least one registered
nurse assigned to the duties of the circulating nurse and a minimum
of one additional person serving as scrub assistant for each
patient-occupied operating room. The scrub assistant may be a
licensed nurse, an operating room technician, or other person who has
demonstrated current competence to the clinic as a scrub assistant,
but shall not be a physician or other licensed health professional
who is assisting in the performance of surgery.
   (ii) The licensed nurse-to-patient ratio in a postanesthesia
recovery unit of the anesthesia service shall be one-to-two or fewer
at all times, regardless of the type of general anesthesia the
patient receives.
  SEC. 7.  Section 1212.6 is added to the Health and Safety Code, to
read:
   1212.6.  Every clinic for which a license has been issued under
Section 1212.5 shall be subject to the reporting requirements
contained in Section 1279.1 and the penalties imposed under Sections
1280.1, 1280.3, and 1280.4.
  SEC. 8.  Section 1212.7 is added to the Health and Safety Code, to
read:
   1212.7.  It is the intent of the Legislature to provide funding
through an appropriation in the Budget Act or other measure to the
State Department of Public Health, for a loan for the support the
operations of the Licensing and Certification Program for activities
authorized by this chapter relating to the licensure of surgical
clinics. The loan shall be repaid with proceeds from fees collected
pursuant to Section 1266.
  SEC. 9.  Section 1248.1 of the Health and Safety Code is amended to
read:
   1248.1.  No association, corporation, firm, partnership, or person
shall operate, manage, conduct, or maintain an outpatient setting in
this state, unless the setting is one of the following:
   (a) An ambulatory surgical center that is certified to participate
in the Medicare program under Title XVIII (42 U.S.C. Sec. 1395 et
seq.) of the federal Social Security Act.
   (b) Any clinic conducted, maintained, or operated by a federally
recognized Indian tribe or tribal organization, as defined in Section
450 or 1601 of Title 25 of the United States Code, and located on
land recognized as tribal land by the federal government.
   (c) Any clinic directly conducted, maintained, or operated by the
United States or by any of its departments, officers, or agencies.
   (d) Any primary care clinic licensed under subdivision (a) and any
surgical clinic licensed under subdivision (b) of Section 1204.
   (e) Any health facility licensed as a general acute care hospital
under Chapter 2 (commencing with Section 1250).
   (f) Any outpatient setting to the extent that it is used by a
dentist or physician and surgeon in compliance with Article 2.7
(commencing with Section 1646) or Article 2.8 (commencing with
Section 1647) of Chapter 4 of Division 2 of the Business and
Professions Code.
   (g) An outpatient setting accredited by an accreditation agency
approved by the division pursuant to this chapter.
   (h) A setting, including, but not limited to, a mobile van, in
which equipment is used to treat patients admitted to a facility
described in subdivision (a), (d), or (e), and in which the
procedures performed are staffed by the medical staff of, or other
healthcare practitioners with clinical privileges at, the facility
and are subject to the peer review process of the facility but which
setting is not a part of a facility described in subdivision (a),
(d), or (e).
   Nothing in this section shall relieve an association, corporation,
firm, partnership, or person from complying with all other
provisions of law that are otherwise applicable  , including, but
not limited to, licensure as a primary care or specialty clinic as
set forth in Chapter 1 (commencing with Section 1200) of Division 2
of the Health and Safety Code. Surgical   clinics shall be
subject to licensure regardless of any physician ownership interest
 .
  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.