State Codes and Statutes

Statutes > California > Hsc > 1248-1248.85

HEALTH AND SAFETY CODE
SECTION 1248-1248.85



1248.  For purposes of this chapter, the following definitions shall
apply:
   (a) "Division" means the Division of Licensing of the Medical
Board of California.
   (b) "Division of Medical Quality" means the Division of Medical
Quality of the Medical Board of California.
   (c) "Outpatient setting" means any facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in Section 1250, and where
anesthesia, except local anesthesia or peripheral nerve blocks, or
both, is used in compliance with the community standard of practice,
in doses that, when administered have the probability of placing a
patient at risk for loss of the patient's life-preserving protective
reflexes.
   "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.
   (d) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the division pursuant to Sections 1248.15 and 1248.4.




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.



1248.15.  (a) The division 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) All physicians and surgeons transferring patients from an
outpatient setting shall agree to cooperate with the medical staff
peer review process on the transferred case, the results of which
shall be referred back to the outpatient setting, if deemed
appropriate by the medical staff peer review committee. If the
medical staff of the acute care facility determines that
inappropriate care was delivered at the outpatient setting, the acute
care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body, the Health Care Financing
Administration, the State Department of Health Services, and the
appropriate licensing authority.
   (3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of 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 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 the Business
and Professions Code.
   (4) Outpatient settings shall have a system for maintaining
clinical records.
   (5) Outpatient settings shall have a system for patient care and
monitoring procedures.
   (6) (A) Outpatient settings shall have a system for quality
assessment and improvement.
   (B) Members of the medical staff and other practitioners who are
granted clinical privileges shall be professionally qualified and
appropriately credentialed for the performance of privileges granted.
The outpatient setting shall grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
   (C) Clinical privileges shall be periodically reappraised by the
outpatient setting. The scope of procedures performed in the
outpatient setting shall be periodically reviewed and amended as
appropriate.
   (7) Outpatient settings regulated by this chapter that have
multiple service locations governed by the same standards may elect
to have all service sites surveyed on any accreditation survey.
Organizations that do not elect to have all sites surveyed shall have
a sample, not to exceed 20 percent of all service sites, surveyed.
The actual sample size shall be determined by the division. The
accreditation agency shall determine the location of the sites to be
surveyed. Outpatient settings that have five or fewer sites shall
have at least one site surveyed. When an organization that elects to
have a sample of sites surveyed is approved for accreditation, all of
the organizations' sites shall be automatically accredited.
   (8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
   (9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
   (10) Outpatient settings shall have a written discharge criteria.
   (b) Outpatient settings shall have a minimum of two staff persons
on the premises, one of whom shall either be a licensed physician and
surgeon or a licensed health care professional with current
certification in advanced cardiac life support (ACLS), as long as a
patient is present who has not been discharged from supervised care.
Transfer to an unlicensed setting of a patient who does not meet the
discharge criteria adopted pursuant to paragraph (10) of subdivision
(a) shall constitute unprofessional conduct.
   (c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the division to protect the public health and safety.
   (d) No accreditation standard adopted or approved by the division,
and no standard included in any certification program of any
accreditation agency approved by the division, 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.



1248.2.  (a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the division under this chapter.
   (b) The division shall obtain and maintain a list of all
accredited, certified, and licensed outpatient settings from the
information provided by the accreditation, certification, and
licensing agencies approved by the division, and shall notify the
public, upon inquiry, whether a setting is accredited, certified, or
licensed, or whether the setting's accreditation, certification, or
license has been revoked.



1248.25.  If an outpatient setting does not meet the standards
approved by the division, 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.



1248.3.  (a) Certificates of accreditation issued to outpatient
settings by an accreditation agency 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.



1248.35.  (a) The Division of Medical Quality or an accreditation
agency may, upon reasonable prior notice and presentation of proper
identification, 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.
   (b) If an accreditation agency determines, as a result of its
inspection, that an outpatient setting is not in compliance with the
standards under which it was approved, the accreditation agency may
do any of the following:
   (1) Issue a reprimand.
   (2) Place the outpatient setting on probation, during which time
the setting shall successfully institute and complete a plan of
correction, approved by the division or the accreditation agency, to
correct the deficiencies.
   (3) Suspend or revoke the outpatient setting's certification of
accreditation.
   (c) 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 reasonable time to supply
information demonstrating compliance with the standards of the
accreditation agency in compliance with this chapter, as well as the
opportunity for a hearing on the matter upon the request of the
outpatient center. 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.
   (d) If the division determines that deficiencies found during an
inspection suggests that the accreditation agency does not comply
with the standards approved by the division, the division may conduct
inspections, as described in this section, of other settings
accredited by the accreditation agency to determine if the agency is
accrediting settings in accordance with Section 1248.15.



1248.4.  (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
setting.
   (2) Submits its current accreditation standards to the division
every three years, or upon request for continuing approval by the
division.
   (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
following:
   (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.



1248.5.  The division may 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
division.



1248.55.  (a) If the accreditation agency is not meeting the
criteria set by the division, the division may terminate approval of
the agency.
   (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.



1248.6.  (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.



1248.65.  It shall constitute unprofessional conduct for a physician
and surgeon to willfully and knowingly violate this chapter.



1248.7.  The Division of Medical Quality or the local district
attorney may bring an action to enjoin a violation or threatened
violation 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.
   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.



1248.75.  (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
setting.
   (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
1248.7.


1248.8.  (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.



1248.85.  Nothing in this chapter shall preclude an approved
accreditation agency from adopting additional standards consistent
with Section 1248.15, establishing procedures for the conduct of
surveys, selecting surveyors to perform accreditation surveys, or
establishing and collecting reasonable fees for the conduct of
accreditation surveys.


State Codes and Statutes

Statutes > California > Hsc > 1248-1248.85

HEALTH AND SAFETY CODE
SECTION 1248-1248.85



1248.  For purposes of this chapter, the following definitions shall
apply:
   (a) "Division" means the Division of Licensing of the Medical
Board of California.
   (b) "Division of Medical Quality" means the Division of Medical
Quality of the Medical Board of California.
   (c) "Outpatient setting" means any facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in Section 1250, and where
anesthesia, except local anesthesia or peripheral nerve blocks, or
both, is used in compliance with the community standard of practice,
in doses that, when administered have the probability of placing a
patient at risk for loss of the patient's life-preserving protective
reflexes.
   "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.
   (d) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the division pursuant to Sections 1248.15 and 1248.4.




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.



1248.15.  (a) The division 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) All physicians and surgeons transferring patients from an
outpatient setting shall agree to cooperate with the medical staff
peer review process on the transferred case, the results of which
shall be referred back to the outpatient setting, if deemed
appropriate by the medical staff peer review committee. If the
medical staff of the acute care facility determines that
inappropriate care was delivered at the outpatient setting, the acute
care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body, the Health Care Financing
Administration, the State Department of Health Services, and the
appropriate licensing authority.
   (3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of 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 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 the Business
and Professions Code.
   (4) Outpatient settings shall have a system for maintaining
clinical records.
   (5) Outpatient settings shall have a system for patient care and
monitoring procedures.
   (6) (A) Outpatient settings shall have a system for quality
assessment and improvement.
   (B) Members of the medical staff and other practitioners who are
granted clinical privileges shall be professionally qualified and
appropriately credentialed for the performance of privileges granted.
The outpatient setting shall grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
   (C) Clinical privileges shall be periodically reappraised by the
outpatient setting. The scope of procedures performed in the
outpatient setting shall be periodically reviewed and amended as
appropriate.
   (7) Outpatient settings regulated by this chapter that have
multiple service locations governed by the same standards may elect
to have all service sites surveyed on any accreditation survey.
Organizations that do not elect to have all sites surveyed shall have
a sample, not to exceed 20 percent of all service sites, surveyed.
The actual sample size shall be determined by the division. The
accreditation agency shall determine the location of the sites to be
surveyed. Outpatient settings that have five or fewer sites shall
have at least one site surveyed. When an organization that elects to
have a sample of sites surveyed is approved for accreditation, all of
the organizations' sites shall be automatically accredited.
   (8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
   (9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
   (10) Outpatient settings shall have a written discharge criteria.
   (b) Outpatient settings shall have a minimum of two staff persons
on the premises, one of whom shall either be a licensed physician and
surgeon or a licensed health care professional with current
certification in advanced cardiac life support (ACLS), as long as a
patient is present who has not been discharged from supervised care.
Transfer to an unlicensed setting of a patient who does not meet the
discharge criteria adopted pursuant to paragraph (10) of subdivision
(a) shall constitute unprofessional conduct.
   (c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the division to protect the public health and safety.
   (d) No accreditation standard adopted or approved by the division,
and no standard included in any certification program of any
accreditation agency approved by the division, 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.



1248.2.  (a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the division under this chapter.
   (b) The division shall obtain and maintain a list of all
accredited, certified, and licensed outpatient settings from the
information provided by the accreditation, certification, and
licensing agencies approved by the division, and shall notify the
public, upon inquiry, whether a setting is accredited, certified, or
licensed, or whether the setting's accreditation, certification, or
license has been revoked.



1248.25.  If an outpatient setting does not meet the standards
approved by the division, 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.



1248.3.  (a) Certificates of accreditation issued to outpatient
settings by an accreditation agency 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.



1248.35.  (a) The Division of Medical Quality or an accreditation
agency may, upon reasonable prior notice and presentation of proper
identification, 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.
   (b) If an accreditation agency determines, as a result of its
inspection, that an outpatient setting is not in compliance with the
standards under which it was approved, the accreditation agency may
do any of the following:
   (1) Issue a reprimand.
   (2) Place the outpatient setting on probation, during which time
the setting shall successfully institute and complete a plan of
correction, approved by the division or the accreditation agency, to
correct the deficiencies.
   (3) Suspend or revoke the outpatient setting's certification of
accreditation.
   (c) 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 reasonable time to supply
information demonstrating compliance with the standards of the
accreditation agency in compliance with this chapter, as well as the
opportunity for a hearing on the matter upon the request of the
outpatient center. 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.
   (d) If the division determines that deficiencies found during an
inspection suggests that the accreditation agency does not comply
with the standards approved by the division, the division may conduct
inspections, as described in this section, of other settings
accredited by the accreditation agency to determine if the agency is
accrediting settings in accordance with Section 1248.15.



1248.4.  (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
setting.
   (2) Submits its current accreditation standards to the division
every three years, or upon request for continuing approval by the
division.
   (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
following:
   (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.



1248.5.  The division may 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
division.



1248.55.  (a) If the accreditation agency is not meeting the
criteria set by the division, the division may terminate approval of
the agency.
   (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.



1248.6.  (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.



1248.65.  It shall constitute unprofessional conduct for a physician
and surgeon to willfully and knowingly violate this chapter.



1248.7.  The Division of Medical Quality or the local district
attorney may bring an action to enjoin a violation or threatened
violation 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.
   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.



1248.75.  (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
setting.
   (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
1248.7.


1248.8.  (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.



1248.85.  Nothing in this chapter shall preclude an approved
accreditation agency from adopting additional standards consistent
with Section 1248.15, establishing procedures for the conduct of
surveys, selecting surveyors to perform accreditation surveys, or
establishing and collecting reasonable fees for the conduct of
accreditation surveys.



State Codes and Statutes

State Codes and Statutes

Statutes > California > Hsc > 1248-1248.85

HEALTH AND SAFETY CODE
SECTION 1248-1248.85



1248.  For purposes of this chapter, the following definitions shall
apply:
   (a) "Division" means the Division of Licensing of the Medical
Board of California.
   (b) "Division of Medical Quality" means the Division of Medical
Quality of the Medical Board of California.
   (c) "Outpatient setting" means any facility, clinic, unlicensed
clinic, center, office, or other setting that is not part of a
general acute care facility, as defined in Section 1250, and where
anesthesia, except local anesthesia or peripheral nerve blocks, or
both, is used in compliance with the community standard of practice,
in doses that, when administered have the probability of placing a
patient at risk for loss of the patient's life-preserving protective
reflexes.
   "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.
   (d) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the division pursuant to Sections 1248.15 and 1248.4.




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.



1248.15.  (a) The division 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) All physicians and surgeons transferring patients from an
outpatient setting shall agree to cooperate with the medical staff
peer review process on the transferred case, the results of which
shall be referred back to the outpatient setting, if deemed
appropriate by the medical staff peer review committee. If the
medical staff of the acute care facility determines that
inappropriate care was delivered at the outpatient setting, the acute
care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body, the Health Care Financing
Administration, the State Department of Health Services, and the
appropriate licensing authority.
   (3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of 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 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 the Business
and Professions Code.
   (4) Outpatient settings shall have a system for maintaining
clinical records.
   (5) Outpatient settings shall have a system for patient care and
monitoring procedures.
   (6) (A) Outpatient settings shall have a system for quality
assessment and improvement.
   (B) Members of the medical staff and other practitioners who are
granted clinical privileges shall be professionally qualified and
appropriately credentialed for the performance of privileges granted.
The outpatient setting shall grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting.
   (C) Clinical privileges shall be periodically reappraised by the
outpatient setting. The scope of procedures performed in the
outpatient setting shall be periodically reviewed and amended as
appropriate.
   (7) Outpatient settings regulated by this chapter that have
multiple service locations governed by the same standards may elect
to have all service sites surveyed on any accreditation survey.
Organizations that do not elect to have all sites surveyed shall have
a sample, not to exceed 20 percent of all service sites, surveyed.
The actual sample size shall be determined by the division. The
accreditation agency shall determine the location of the sites to be
surveyed. Outpatient settings that have five or fewer sites shall
have at least one site surveyed. When an organization that elects to
have a sample of sites surveyed is approved for accreditation, all of
the organizations' sites shall be automatically accredited.
   (8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
   (9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
   (10) Outpatient settings shall have a written discharge criteria.
   (b) Outpatient settings shall have a minimum of two staff persons
on the premises, one of whom shall either be a licensed physician and
surgeon or a licensed health care professional with current
certification in advanced cardiac life support (ACLS), as long as a
patient is present who has not been discharged from supervised care.
Transfer to an unlicensed setting of a patient who does not meet the
discharge criteria adopted pursuant to paragraph (10) of subdivision
(a) shall constitute unprofessional conduct.
   (c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the division to protect the public health and safety.
   (d) No accreditation standard adopted or approved by the division,
and no standard included in any certification program of any
accreditation agency approved by the division, 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.



1248.2.  (a) Any outpatient setting may apply to an accreditation
agency for a certificate of accreditation. Accreditation shall be
issued by the accreditation agency solely on the basis of compliance
with its standards as approved by the division under this chapter.
   (b) The division shall obtain and maintain a list of all
accredited, certified, and licensed outpatient settings from the
information provided by the accreditation, certification, and
licensing agencies approved by the division, and shall notify the
public, upon inquiry, whether a setting is accredited, certified, or
licensed, or whether the setting's accreditation, certification, or
license has been revoked.



1248.25.  If an outpatient setting does not meet the standards
approved by the division, 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.



1248.3.  (a) Certificates of accreditation issued to outpatient
settings by an accreditation agency 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.



1248.35.  (a) The Division of Medical Quality or an accreditation
agency may, upon reasonable prior notice and presentation of proper
identification, 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.
   (b) If an accreditation agency determines, as a result of its
inspection, that an outpatient setting is not in compliance with the
standards under which it was approved, the accreditation agency may
do any of the following:
   (1) Issue a reprimand.
   (2) Place the outpatient setting on probation, during which time
the setting shall successfully institute and complete a plan of
correction, approved by the division or the accreditation agency, to
correct the deficiencies.
   (3) Suspend or revoke the outpatient setting's certification of
accreditation.
   (c) 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 reasonable time to supply
information demonstrating compliance with the standards of the
accreditation agency in compliance with this chapter, as well as the
opportunity for a hearing on the matter upon the request of the
outpatient center. 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.
   (d) If the division determines that deficiencies found during an
inspection suggests that the accreditation agency does not comply
with the standards approved by the division, the division may conduct
inspections, as described in this section, of other settings
accredited by the accreditation agency to determine if the agency is
accrediting settings in accordance with Section 1248.15.



1248.4.  (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
setting.
   (2) Submits its current accreditation standards to the division
every three years, or upon request for continuing approval by the
division.
   (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
following:
   (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.



1248.5.  The division may 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
division.



1248.55.  (a) If the accreditation agency is not meeting the
criteria set by the division, the division may terminate approval of
the agency.
   (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.



1248.6.  (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.



1248.65.  It shall constitute unprofessional conduct for a physician
and surgeon to willfully and knowingly violate this chapter.



1248.7.  The Division of Medical Quality or the local district
attorney may bring an action to enjoin a violation or threatened
violation 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.
   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.



1248.75.  (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
setting.
   (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
1248.7.


1248.8.  (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.



1248.85.  Nothing in this chapter shall preclude an approved
accreditation agency from adopting additional standards consistent
with Section 1248.15, establishing procedures for the conduct of
surveys, selecting surveyors to perform accreditation surveys, or
establishing and collecting reasonable fees for the conduct of
accreditation surveys.