BILL NUMBER: SB 396 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Hill
FEBRUARY 25, 2015
An act to amend Sections 805 and 805.5 of, and to add Section
2216.5 to, the Business and Professions Code, and to amend Sections
1204, 1248.15, 1248.3, and 1248.35 of the Health and Safety Code,
relating to health and care facilities.
LEGISLATIVE COUNSEL'S DIGEST
SB 396, as introduced, Hill. Health and care facilities:
outpatient settings and surgical clinics.
Existing law provides for the licensure and regulation of clinics
by the State Department of Public Health. A violation of those
provisions is a misdemeanor. Existing law provides that certain types
of specialty clinics, including surgical clinics, as defined, are
eligible for licensure.
This bill would clarify that a surgical clinic is eligible for
licensure by the department regardless of physician or dentist
ownership.
The Medical Practice Act provides for the licensure and regulation
of physicians and surgeons by the Medical Board of California.
Existing law provides that it is unprofessional conduct for a
physician and surgeon to perform procedures in any outpatient setting
except in compliance with specified provisions. Existing law
prohibits an association, corporation, firm, partnership, or person
from operating, managing, conducting, or maintaining an outpatient
setting in the state unless the setting is one of the specified
settings, which includes, among others, a surgical clinic licensed by
the State Department of Public Health or an outpatient setting
accredited by an accreditation agency approved by the Division of
Licensing of the Medical Board of California.
Existing law provides that an outpatient setting that is
accredited shall be inspected by the accreditation agency and may be
inspected by the Medical Board of California. Existing law requires
that the inspections be conducted no less often than once every 3
years by the accreditation agency and as often as necessary by the
Medical Board of California to ensure quality of care provided.
Existing law requires that certificates for accreditation issued to
outpatient settings by an accreditation agency shall be valid for not
more than 3 years.
This bill would require that all subsequent inspections after the
initial inspection for accreditation be unannounced. This bill would
require an outpatient setting accredited by the division to pay
certain fees and to comply with certain data submission requirements.
The bill would also instead require that an initial certificate of
accreditation by an accreditation agency be valid for not more than 2
years and that a renewal certificate be valid for not more than 3
years.
Existing law requires members of the medical staff and other
practitioners who are granted clinical privileges in an outpatient
setting to be professionally qualified and appropriately credentialed
for the performance of privileges granted and requires the
outpatient setting to grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
This bill would additionally require that each physician and
surgeon who performs procedures in an outpatient setting that
requires the outpatient setting to be accredited be peer reviewed by
California licensed physicians who are qualified by education
experience to perform the same types of procedures. By expanding the
scope of a crime, this bill would impose a state-mandated local
program.
Existing law requires specified entities, including any health
care service plan or medical care foundation, to request a report
from the Medical Board of California, the Board of Psychology, the
Osteopathic Medical Board of California, or the Dental Board of
California, prior to granting or renewing staff privileges, to
determine if a certain report has been made indicating that the
applying physician and surgeon, psychologist, podiatrist, or dentist
has been denied staff privileges, been removed from a medical staff,
or had his or her staff privileges restricted.
This bill would also require an outpatient setting and a facility
certified to participate in the federal Medicare program as an
ambulatory surgical center to request that report. By expanding the
scope of a crime, this bill would impose a state-mandated local
program.
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. Section 805 of the Business and Professions Code is
amended to read:
805. (a) As used in this section, the following terms have the
following definitions:
(1) (A) "Peer review" means both of the following:
(i) A process in which a peer review body reviews the basic
qualifications, staff privileges, employment, medical outcomes, or
professional conduct of licentiates to make recommendations for
quality improvement and education, if necessary, in order to do
either or both of the following:
(I) Determine whether a licentiate may practice or continue to
practice in a health care facility, clinic, or other setting
providing medical services, and, if so, to determine the parameters
of that practice.
(II) Assess and improve the quality of care rendered in a health
care facility, clinic, or other setting providing medical services.
(ii) Any other activities of a peer review body as specified in
subparagraph (B).
(B) "Peer review body" includes:
(i) A medical or professional staff of any health care facility or
clinic licensed under Division 2 (commencing with Section 1200) of
the Health and Safety Code or Code, of
a facility certified to participate in the federal Medicare program
as an ambulatory surgical center. center, or
of an outpatient setting accredited pursuant to Section 1248.1 of the
Health and Safety Code.
(ii) A health care service plan licensed under Chapter 2.2
(commencing with Section 1340) of Division 2 of the Health and Safety
Code or a disability insurer that contracts with licentiates to
provide services at alternative rates of payment pursuant to Section
10133 of the Insurance Code.
(iii) Any medical, psychological, marriage and family therapy,
social work, professional clinical counselor, dental, or podiatric
professional society having as members at least 25 percent of the
eligible licentiates in the area in which it functions (which must
include at least one county), which is not organized for profit and
which has been determined to be exempt from taxes pursuant to Section
23701 of the Revenue and Taxation Code.
(iv) A committee organized by any entity consisting of or
employing more than 25 licentiates of the same class that functions
for the purpose of reviewing the quality of professional care
provided by members or employees of that entity.
(2) "Licentiate" means a physician and surgeon, doctor of
podiatric medicine, clinical psychologist, marriage and family
therapist, clinical social worker, professional clinical counselor,
dentist, or physician assistant. "Licentiate" also includes a person
authorized to practice medicine pursuant to Section 2113 or 2168.
(3) "Agency" means the relevant state licensing agency having
regulatory jurisdiction over the licentiates listed in paragraph (2).
(4) "Staff privileges" means any arrangement under which a
licentiate is allowed to practice in or provide care for patients in
a health facility. Those arrangements shall include, but are not
limited to, full staff privileges, active staff privileges, limited
staff privileges, auxiliary staff privileges, provisional staff
privileges, temporary staff privileges, courtesy staff privileges,
locum tenens arrangements, and contractual arrangements to provide
professional services, including, but not limited to, arrangements to
provide outpatient services.
(5) "Denial or termination of staff privileges, membership, or
employment" includes failure or refusal to renew a contract or to
renew, extend, or reestablish any staff privileges, if the action is
based on medical disciplinary cause or reason.
(6) "Medical disciplinary cause or reason" means that aspect of a
licentiate's competence or professional conduct that is reasonably
likely to be detrimental to patient safety or to the delivery of
patient care.
(7) "805 report" means the written report required under
subdivision (b).
(b) The chief of staff of a medical or professional staff or other
chief executive officer, medical director, or administrator of any
peer review body and the chief executive officer or administrator of
any licensed health care facility or clinic shall file an 805 report
with the relevant agency within 15 days after the effective date on
which any of the following occur as a result of an action of a peer
review body:
(1) A licentiate's application for staff privileges or membership
is denied or rejected for a medical disciplinary cause or reason.
(2) A licentiate's membership, staff privileges, or employment is
terminated or revoked for a medical disciplinary cause or reason.
(3) Restrictions are imposed, or voluntarily accepted, on staff
privileges, membership, or employment for a cumulative total of 30
days or more for any 12-month period, for a medical disciplinary
cause or reason.
(c) If a licentiate takes any action listed in paragraph (1), (2),
or (3) after receiving notice of a pending investigation initiated
for a medical disciplinary cause or reason or after receiving notice
that his or her application for membership or staff privileges is
denied or will be denied for a medical disciplinary cause or reason,
the chief of staff of a medical or professional staff or other chief
executive officer, medical director, or administrator of any peer
review body and the chief executive officer or administrator of any
licensed health care facility or clinic where the licentiate is
employed or has staff privileges or membership or where the
licentiate applied for staff privileges or membership, or sought the
renewal thereof, shall file an 805 report with the relevant agency
within 15 days after the licentiate takes the action.
(1) Resigns or takes a leave of absence from membership, staff
privileges, or employment.
(2) Withdraws or abandons his or her application for staff
privileges or membership.
(3) Withdraws or abandons his or her request for renewal of staff
privileges or membership.
(d) For purposes of filing an 805 report, the signature of at
least one of the individuals indicated in subdivision (b) or (c) on
the completed form shall constitute compliance with the requirement
to file the report.
(e) An 805 report shall also be filed within 15 days following the
imposition of summary suspension of staff privileges, membership, or
employment, if the summary suspension remains in effect for a period
in excess of 14 days.
(f) A copy of the 805 report, and a notice advising the licentiate
of his or her right to submit additional statements or other
information, electronically or otherwise, pursuant to Section 800,
shall be sent by the peer review body to the licentiate named in the
report. The notice shall also advise the licentiate that information
submitted electronically will be publicly disclosed to those who
request the information.
The information to be reported in an 805 report shall include the
name and license number of the licentiate involved, a description of
the facts and circumstances of the medical disciplinary cause or
reason, and any other relevant information deemed appropriate by the
reporter.
A supplemental report shall also be made within 30 days following
the date the licentiate is deemed to have satisfied any terms,
conditions, or sanctions imposed as disciplinary action by the
reporting peer review body. In performing its dissemination functions
required by Section 805.5, the agency shall include a copy of a
supplemental report, if any, whenever it furnishes a copy of the
original 805 report.
If another peer review body is required to file an 805 report, a
health care service plan is not required to file a separate report
with respect to action attributable to the same medical disciplinary
cause or reason. If the Medical Board of California or a licensing
agency of another state revokes or suspends, without a stay, the
license of a physician and surgeon, a peer review body is not
required to file an 805 report when it takes an action as a result of
the revocation or suspension.
(g) The reporting required by this section shall not act as a
waiver of confidentiality of medical records and committee reports.
The information reported or disclosed shall be kept confidential
except as provided in subdivision (c) of Section 800 and Sections
803.1 and 2027, provided that a copy of the report containing the
information required by this section may be disclosed as required by
Section 805.5 with respect to reports received on or after January 1,
1976.
(h) The Medical Board of California, the Osteopathic Medical Board
of California, and the Dental Board of California shall disclose
reports as required by Section 805.5.
(i) An 805 report shall be maintained electronically by an agency
for dissemination purposes for a period of three years after receipt.
(j) No person shall incur any civil or criminal liability as the
result of making any report required by this section.
(k) A willful failure to file an 805 report by any person who is
designated or otherwise required by law to file an 805 report is
punishable by a fine not to exceed one hundred thousand dollars
($100,000) per violation. The fine may be imposed in any civil or
administrative action or proceeding brought by or on behalf of any
agency having regulatory jurisdiction over the person regarding whom
the report was or should have been filed. If the person who is
designated or otherwise required to file an 805 report is a licensed
physician and surgeon, the action or proceeding shall be brought by
the Medical Board of California. The fine shall be paid to that
agency but not expended until appropriated by the Legislature. A
violation of this subdivision may constitute unprofessional conduct
by the licentiate. A person who is alleged to have violated this
subdivision may assert any defense available at law. As used in this
subdivision, "willful" means a voluntary and intentional violation of
a known legal duty.
(l) Except as otherwise provided in subdivision (k), any failure
by the administrator of any peer review body, the chief executive
officer or administrator of any health care facility, or any person
who is designated or otherwise required by law to file an 805 report,
shall be punishable by a fine that under no circumstances shall
exceed fifty thousand dollars ($50,000) per violation. The fine may
be imposed in any civil or administrative action or proceeding
brought by or on behalf of any agency having regulatory jurisdiction
over the person regarding whom the report was or should have been
filed. If the person who is designated or otherwise required to file
an 805 report is a licensed physician and surgeon, the action or
proceeding shall be brought by the Medical Board of California. The
fine shall be paid to that agency but not expended until appropriated
by the Legislature. The amount of the fine imposed, not exceeding
fifty thousand dollars ($50,000) per violation, shall be proportional
to the severity of the failure to report and shall differ based upon
written findings, including whether the failure to file caused harm
to a patient or created a risk to patient safety; whether the
administrator of any peer review body, the chief executive officer or
administrator of any health care facility, or any person who is
designated or otherwise required by law to file an 805 report
exercised due diligence despite the failure to file or whether they
knew or should have known that an 805 report would not be filed; and
whether there has been a prior failure to file an 805 report. The
amount of the fine imposed may also differ based on whether a health
care facility is a small or rural hospital as defined in Section
124840 of the Health and Safety Code.
(m) A health care service plan licensed under Chapter 2.2
(commencing with Section 1340) of Division 2 of the Health and Safety
Code or a disability insurer that negotiates and enters into a
contract with licentiates to provide services at alternative rates of
payment pursuant to Section 10133 of the Insurance Code, when
determining participation with the plan or insurer, shall evaluate,
on a case-by-case basis, licentiates who are the subject of an 805
report, and not automatically exclude or deselect these licentiates.
SEC. 2. Section 805.5 of the Business and Professions Code is
amended to read:
805.5. (a) Prior to granting or renewing staff privileges for any
physician and surgeon, psychologist, podiatrist, or dentist, any
health facility licensed pursuant to Division 2 (commencing with
Section 1200) of the Health and Safety Code, or
any health care service plan or medical care foundation, or
the medical staff of the institution
institution, a facility certified to participate in
the federal Medicare program as an ambulatory surgical
center, or an outpatient setting accredited pursuant to
Section 1248.1 of the Health and Safety Code shall request a
report from the Medical Board of California, the Board of Psychology,
the Osteopathic Medical Board of California, or the Dental Board of
California to determine if any report has been made pursuant to
Section 805 indicating that the applying physician and surgeon,
psychologist, podiatrist, or dentist has been denied staff
privileges, been removed from a medical staff, or had his or her
staff privileges restricted as provided in Section 805. The request
shall include the name and California license number of the physician
and surgeon, psychologist, podiatrist, or dentist. Furnishing of a
copy of the 805 report shall not cause the 805 report to be a public
record.
(b) Upon a request made by, or on behalf of, an institution
described in subdivision (a) or its medical staff the board shall
furnish a copy of any report made pursuant to Section 805 as well as
any additional exculpatory or explanatory information submitted
electronically to the board by the licensee pursuant to subdivision
(f) of that section. However, the board shall not send a copy of a
report (1) if the denial, removal, or restriction was imposed solely
because of the failure to complete medical records, (2) if the board
has found the information reported is without merit, (3) if a court
finds, in a final judgment, that the peer review, as defined in
Section 805, resulting in the report was conducted in bad faith and
the licensee who is the subject of the report notifies the board of
that finding, or (4) if a period of three years has elapsed since the
report was submitted. This three-year period shall be tolled during
any period the licentiate has obtained a judicial order precluding
disclosure of the report, unless the board is finally and permanently
precluded by judicial order from disclosing the report. If a request
is received by the board while the board is subject to a judicial
order limiting or precluding disclosure, the board shall provide a
disclosure to any qualified requesting party as soon as practicable
after the judicial order is no longer in force.
If the board fails to advise the institution within 30 working
days following its request for a report required by this section, the
institution may grant or renew staff privileges for the physician
and surgeon, psychologist, podiatrist, or dentist.
(c) Any institution described in subdivision (a) or its medical
staff that violates subdivision (a) is guilty of a misdemeanor and
shall be punished by a fine of not less than two hundred dollars
($200) nor more than one thousand two hundred dollars ($1,200).
SEC. 3. Section 2216.5 is added to the Business and Professions
Code, to read:
2216.5. An outpatient setting accredited pursuant to Section
1248.1 of the Health and Safety Code is subject to the requirements
of Section 1216, subdivision (f) of Section 127280, and Section
128737 of the Health and Safety Code.
SEC. 4. 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) A "surgical clinic" means a clinic
that is not part of a hospital and that provides ambulatory surgical
care 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. establishment.
(B) A physician or dentist may, at his or her option, apply for
licensure. A surgical clinic shall be eligible for licensure by the
department regardless of physician or dentist 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.
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.
(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 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) (i) 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.
(ii) Each physician and surgeon who performs procedures in an
outpatient setting that requires the outpatient setting to be
accredited shall be peer reviewed, as described in Section 805 of the
Business and Professions Code, including when the outpatient setting
has only one physician and surgeon. The peer review shall be
performed by California licensed physicians who are qualified by
education experience to perform the same types of procedures.
(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.
SEC. 6. Section 1248.3 of the Health and Safety Code is amended to
read:
1248.3. (a) Certificates An
initial certificate of accreditation issued to
an outpatient settings setting by
an accreditation agency shall be valid for not more than two
years, and a renewal certificate shall be valid for not more than
three years.
(b) The outpatient setting shall notify the accreditation agency
within 30 days of any significant change in ownership, including, but
not limited to, a merger, change in majority interest,
consolidation, name change, change in scope of services, additional
services, or change in locations.
(c) Except for disclosures to the division or to the Division of
Medical Quality under this chapter, an accreditation agency shall not
disclose information obtained in the performance of accreditation
activities under this chapter that individually identifies patients,
individual medical practitioners, or outpatient settings. Neither the
proceedings nor the records of an accreditation agency or the
proceedings and records of an outpatient setting related to
performance of quality assurance or accreditation activities under
this chapter shall be subject to discovery, nor shall the records or
proceedings be admissible in a court of law. The prohibition relating
to discovery and admissibility of records and proceedings does not
apply to any outpatient setting requesting accreditation in the event
that denial or revocation of that outpatient setting's accreditation
is being contested. Nothing in this section shall prohibit the
accreditation agency from making discretionary disclosures of
information to an outpatient setting pertaining to the accreditation
of that outpatient setting.
SEC. 7. Section 1248.35 of the Health and Safety Code is amended
to read:
1248.35. (a) Every outpatient setting which
that 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. After the initial inspection for accreditation, all
subsequent inspections shall be unannounced.
(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 and to the California State Board of Pharmacy if an outpatient
setting is licensed pursuant to Article 14 (commencing with Section
4190) of Chapter 9 of Division 2 of the Business and Professions
Code. 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. If an outpatient setting has been issued a license by the
California State Board of Pharmacy pursuant to Article 14 (commencing
with Section 4190) of Chapter 9 of Division 2 of the Business and
Professions Code, the accreditation agency shall also send this
report to the California State Board of Pharmacy within 24 hours.
(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. 8. 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.