Chapter 1.3. Outpatient Settings of California Health And Safety Code >> Division 2. >> Chapter 1.3.
For purposes of this chapter, the following definitions shall
(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
(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
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
(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.
(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
(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) 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
(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
(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
(5) Outpatient settings shall have a system for patient care and
(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 licensee who performs procedures in an outpatient
setting that requires the outpatient setting to be accredited shall
be, at least every two years, peer reviewed, which shall be a process
in which the basic qualifications, staff privileges, employment,
medical outcomes, or professional conduct of a licensee is reviewed
to make recommendations for quality improvement and education, if
necessary, including when the outpatient setting has only one
licensee. The peer review shall be performed by licensees who are
qualified by education and experience to perform the same types of,
or similar, procedures. The findings of the peer review shall be
reported to the governing body, which shall determine if the licensee
continues to meet the requirements described in clause (i). The
process that resulted in the findings of the peer review shall be
reviewed by the accrediting agency at the next survey to determine if
the outpatient setting meets applicable accreditation standards
pursuant to this section.
(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
(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.
(a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the board under this chapter.
(b) The board shall obtain and maintain a list of accredited
outpatient settings from the information provided by the
accreditation agencies approved by the board, and shall notify the
public, by placing the information on its Internet Web site, whether
an outpatient setting is accredited or the setting's accreditation
has been revoked, suspended, or placed on probation, or the setting
has received a reprimand by the accreditation agency.
(c) The list of outpatient settings shall include all of the
(1) Name, address, and telephone number of any owners, and their
medical license numbers.
(2) Name and address of the facility.
(3) The name and telephone number of the accreditation agency.
(4) The effective and expiration dates of the accreditation.
(d) Accrediting agencies approved by the board shall notify the
board and update the board on all outpatient settings that are
If an outpatient setting does not meet the standards
approved by the board, accreditation shall be denied by the
accreditation agency, which shall provide the outpatient setting
notification of the reasons for the denial. An outpatient setting may
reapply for accreditation at any time after receiving notification
of the denial. The accreditation agency shall report within three
business days to the board if the outpatient setting's certificate
for accreditation has been denied.
(a) Certificates of accreditation issued to outpatient
settings by an accreditation agency shall be valid for not more than
(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.
(a) Every outpatient setting 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, subsequent
inspections may be unannounced. For unannounced routine inspections,
the accreditation agency shall notify the outpatient setting that the
inspection will occur within 60 days.
(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'
(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
(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
(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
(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.
(a) It is the intent of the Legislature that an
accreditation agency operating on or before January 1, 1995, or a
successor thereof, or an accreditation agency thereafter operating as
part of a joint program granted temporary certification as an
accreditation agency by the division, whether operating as part of a
joint program or independently, and meeting the standards set forth
in this chapter, as determined by the division, not be required to go
through the entire application process with the division. Therefore,
the division may grant a temporary certificate of approval to such
an accreditation agency. The temporary approval issued to an
accreditation agency under this subdivision shall expire on January
1, 1998. In order to continue its status as an accreditation agency,
an accreditation agency approved by the division under this
subdivision shall apply for renewal of approval by the division on or
before January 1, 1998, and shall establish that it is in compliance
with the standards set forth in this chapter and any regulations
adopted pursuant thereto.
(b) Each accreditation agency approved by the division shall, on
and after January 1, 1995, promptly forward to the division a list of
each outpatient setting to which it has granted a certificate of
accreditation, as well as settings that have lost accreditation or
were denied accreditation.
(c) The division shall approve an accreditation agency that
applies for approval on a form prescribed by the division,
accompanied by payment of the fee prescribed by this chapter and
evidence that the accreditation agency meets the following criteria:
(1) Includes within its accreditation program, at a minimum, the
standards for accreditation of outpatient settings approved by the
division as well as standards for patient care and safety at the
(2) Submits its current accreditation standards to the division
every three years, or upon request for continuing approval by the
(3) Maintains internal quality management programs to ensure
quality of the accreditation process.
(4) Has a process by which accreditation standards can be reviewed
and revised no less than every three years.
(5) Maintains an available pool of allied health care
practitioners to serve on accreditation review teams as appropriate.
(6) Has accreditation review teams that shall do all of the
(A) Consist of at least one physician and surgeon who practices in
an outpatient setting; any other members shall be practicing
actively in these settings.
(B) Participate in formal educational training programs provided
by the accreditation agency in evaluation of the certification
standards at least every three years.
(7) The accreditation agency shall demonstrate that professional
members of its review team have experience in conducting review
activities of freestanding outpatient settings.
(8) Standards for accreditation shall be developed with the input
of the medical community and the ambulatory surgery industry.
(9) Accreditation reviewers shall be credentialed and screened by
the accreditation agency.
(10) The accreditation agency shall not have an ownership interest
in nor be involved in the operation of a freestanding outpatient
setting, nor in the delivery of health care services to patients.
(d) Accreditation agencies approved by the division shall forward
to the division copies of all certificates of accreditation and shall
notify the division promptly whenever the agency denies or revokes a
certificate of accreditation.
(e) A certification of an accreditation agency by the division
shall expire at midnight on the last day of a three-year term if not
renewed. The division shall establish by regulation the procedure for
renewal. To renew an unexpired approval, the accreditation agency
shall, on or before the date upon which the certification would
otherwise expire, apply for renewal on a form, and pay the renewal
fee, as prescribed by the division.
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.
(a) If the accreditation agency is not meeting the
criteria set by the division, the division may terminate approval of
(b) Before terminating approval of an accreditation agency, the
division 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.
(c) (1) If approval of the accreditation agency is terminated by
the division, outpatient settings accredited by that agency shall be
notified by the division 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 division for good cause.
(2) The division may require that an outpatient setting, that has
been accredited by an accreditation agency whose approval has been
terminated by the division, cease operations immediately in the event
that the division 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 division 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 division promptly of its reapplication.
(a) The Division of Licensing shall establish by regulation
a reasonable fee for an application for approval as an accreditation
agency in an amount that is reasonably necessary to recover the cost
of implementing and administering this chapter, and not to exceed
five thousand dollars ($5,000). The division shall establish by
regulation a reasonable fee for a temporary certificate of approval,
as outlined in subdivision (a) of Section 1248.4, not to exceed two
thousand dollars ($2,000). The division shall also establish a
reasonable fee for renewal. The renewal fee shall be proportionate to
the number of outpatient settings accredited by the approved
accrediting body seeking renewal, and shall not exceed one hundred
dollars ($100) per outpatient setting accreditation reviewed.
(b) All fees paid to and received by the division or the Medical
Board of California under this chapter shall be paid into the State
Treasury and shall be credited to a special fund that is hereby
created as the Outpatient Setting Fund of the Medical Board of
California. Funds in the Outpatient Setting Fund of the Medical Board
of California shall be expended by the board for the purpose of
implementing and administering this chapter upon appropriation by the
Legislature. No surplus in the fund shall be deposited in or
transferred to the General Fund or any other fund.
It shall constitute unprofessional conduct for a physician
and surgeon to willfully and knowingly violate this chapter.
(a) The board shall investigate all complaints concerning a
violation of this chapter. With respect to any complaints relating
to a violation of Section 1248.1, or upon discovery that an
outpatient setting is not in compliance with Section 1248.1, the
board shall investigate and, where appropriate, the board, through or
in conjunction with the local district attorney, shall bring an
action to enjoin the outpatient setting's operation. The board or the
local district attorney may bring an action to enjoin a violation or
threatened violation of any other provision of this chapter in the
superior court in and for the county in which the violation occurred
or is about to occur. Any proceeding under this section shall conform
to the requirements of Chapter 3 (commencing with Section 525) of
Title 7 of Part 2 of the Code of Civil Procedure, except that the
Division of Medical Quality shall not be required to allege facts
necessary to show or tending to show lack of adequate remedy at law
or irreparable damage or loss.
(b) With respect to any and all actions brought pursuant to this
section alleging an actual or threatened violation of any requirement
of this chapter, the court shall, if it finds the allegations to be
true, issue an order enjoining the person or facility from continuing
the violation. For purposes of Section 1248.1, if an outpatient
setting is operating without a certificate of accreditation, this
shall be prima facie evidence that a violation of Section 1248.1 has
occurred and additional proof shall not be necessary to enjoin the
outpatient setting's operation.
(a) Except as may otherwise be provided in this section,
before the Division of Medical Quality may seek an injunction as
provided under Section 1248.7, the Division of Medical Quality shall
notify the outpatient setting of all deficiencies in its compliance
with this chapter, and any rules and regulations adopted pursuant to
this chapter, and the Division of Medical Quality and the outpatient
setting shall reach an agreement upon a plan of correction that shall
give the outpatient setting reasonable time to correct the
deficiencies. The Division of Medical Quality shall also inform the
outpatient setting that failure to reach an agreement or to correct
deficiencies may lead to corrective action by the Division of Medical
Quality, which may include imposition of fines under Section 1248.8.
If at the end of the allotted time the division and the outpatient
setting have failed to reach an agreement or the outpatient setting
has failed to correct the deficiencies, as revealed by inspection,
the Division of Medical Quality may take corrective action to
include, as appropriate, seeking an injunction under Section 1248.7,
revoking or requesting that the accreditation agency revoke
accreditation, or communicating with any agency that has oversight
authority over the outpatient setting, such as the Department of
Health Services or other appropriate licensing authority, to request
that the agency take corrective action against the outpatient
(b) For purposes of this section, and at the sole discretion of
the Division of Medical Quality, any notifications, inspections, and
corrective action plans of the Division of Medical Quality relating
to outpatient settings that have been accredited by an accreditation
agency may be performed or coordinated by the accreditation agency
rather than by the Division of Medical Quality.
(c) If the Division of Medical Quality determines that an
outpatient setting poses an immediate and substantial hazard to the
health or safety of the patient, that may not reasonably be corrected
through a plan of correction, the Division of Medical Quality may
immediately institute injunction proceedings pursuant to Section
(a) Any person or entity that willfully violates this
chapter or any rule or regulation adopted under this chapter shall be
guilty of a misdemeanor and subject to a fine not to exceed one
thousand dollars ($1,000) per day of violation.
(b) In determining the punishment to be imposed under this
section, the court shall consider all relevant facts, including, but
not limited to, the following:
(1) Whether the violation exposed a patient or other individual to
the risk of death or serious physical harm.
(2) Whether the violation had a direct or immediate relationship
to health, safety, or security of a patient or other individual.
(3) Evidence, if any, of willfulness in the violation.
(4) The presence or absence of good faith efforts by the
outpatient setting to prevent the violation.
(c) For purposes of this section, "willfully" or "willful" means
that the person doing an act or omitting to do an act intends the act
or omission, and knows the relevant circumstances connected with the
act or omission.
(d) The district attorney of every county shall, upon application
by the Division of Medical Quality or its authorized representative,
institute and conduct the prosecution of any action or violation
within the county of any provisions of this chapter.
This chapter shall not preclude an approved accreditation
agency from adopting additional standards consistent with Section
1248.15, establishing procedures for the conduct of onsite
inspections, selecting onsite inspectors to perform accreditation
onsite inspections, or establishing and collecting reasonable fees
for the conduct of accreditation onsite inspections.