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Cal Bus & Prof
Code § 2215
DEERING'S CALIFORNIA CODES ANNOTATED
Copyright (c) 2001 by Matthew Bender & Company, one
of the LEXIS Publishing companies.
All rights reserved.
*** THIS SECTION IS CURRENT THROUGH THE 2001 SUPPLEMENT
(2000 SESSION) ***
INCLUDING URGENCY LEGISLATION THROUGH 2001 REG. SESS. CH.
203, 8/12/01, 1ST EX. SESS. CH. 13X, 5/24/01, & 2ND
EX. SESS. CH. 2XX, 8/11/01
BUSINESS & PROFESSIONS CODE
DIVISION 2. Healing Arts
CHAPTER 5. Medicine
ARTICLE 11.5. Surgery in Certain Outpatient Settings
§ 2215. Legislative findings and declarations
The Legislature finds and declares that in this state,
significant surgeries are being performed in unregulated
out-of-hospital settings. The Legislature further finds
and declares that without appropriate oversight, some of
these settings may be operating in a manner which is injurious
to the public health, welfare, and safety. Although the
health professionals delivering health care services in
these settings are licensed, further quality assurance is
needed to ensure that health care services are safely and
effectively performed in these settings. The Legislature
further recognizes that there is a wide range of surgical
procedures safely performed in a myriad of outpatient settings,
and the degree of patient risk varies greatly. It is the
intent of the Legislature to create regulations that directly
impact patient safety. It is not the intent of the Legislature
to require standards in excess of those requirements in
Section 1248.15, or to require physical modifications to
facilities unless the modifications or standards directly
impact patient safety and are cost-effective. The cost effectiveness
of any modifications shall be taken into consideration by
the Division of Licensing of the Medical Board of California,
and shall ensure that the least costly and effective method
of achieving patient safety is required.
§ 2216. Restrictions on use of anesthesia
On or after July 1, 1996, no physician and surgeon shall
perform procedures in an outpatient setting using anesthesia,
except local anesthesia or peripheral nerve blocks, or both,
complying 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, unless the setting is specified in
Section 1248.1. Outpatient settings where anxiolytics and
analgesics are administered are excluded when administered,
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.
The definition of "outpatient settings" contained
in subdivision (c) of Section 1248 shall apply to this section.
§ 2216.1. Minimum number of staff persons required
On and after July 1, 2000, it is unprofessional conduct
for a physician and surgeon to perform procedures in any
outpatient setting except in compliance with Section 2216,
unless the setting has 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.
§ 2216.2. Requirements of adequate security
(a) It is unprofessional conduct for a physician and surgeon
to fail to provide adequate security by liability insurance,
or by participation in an interindemnity trust, for claims
by patients arising out of surgical procedures performed
outside of a general acute care hospital as defined in subdivision
(a) of Section 1250 of the Health and Safety Code.
(b) For purposes of this section, the board shall determine
what constitutes adequate security.
(c) Nothing in this section shall require an insurer admitted
to transact liability insurance in this state to provide
coverage to a physician and surgeon.
(d) The security required by this section shall be acceptable
only if provided by any one of the following:
(1) An insurer admitted pursuant to Section 700 of the
Insurance Code to transact liability insurance in this state.
(2) An insurer that appears on the list of eligible surplus
line insurers pursuant to subdivision (f) of Section 1765.1
of the Insurance Code.
(3) A cooperative corporation authorized by Section 1280.7
of the Insurance Code.
(4) An insurer licensed to transact liability insurance
in at least one state of the United States.
§ 2217. Adoption of regulations
The Division of Licensing of the Medical Board of California
may adopt regulations to implement this article and Chapter
1.3 (commencing with Section 1248) of Division 2 of the
Health and Safety Code.
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BUSINESS & PROFESSIONS CODE
DIVISION 2. Healing Arts
CHAPTER 5. Medicine
ARTICLE 12. Enforcement
§ 2240. Report for death of patient
(a) Any physician and surgeon who performs a scheduled
medical procedure outside of a general acute care hospital,
as defined in subdivision (a) of Section 1250 of the Health
and Safety Code, that results in the death of any patient
on whom that medical treatment was performed by the physician
and surgeon, or by a person acting under the physician and
surgeon's orders or supervision, shall report, in writing
on a form prescribed by the board, that occurrence to the
board within 15 days after the occurrence.
(b) Any physician and surgeon who performs a scheduled
medical procedure outside of a general acute care hospital,
as defined in subdivision (a) of Section 1250 of the Health
and Safety Code, that results in the transfer to a hospital
or emergency center for medical treatment for a period exceeding
24 hours, of any patient on whom that medical treatment
was performed by the physician and surgeon, or by a person
acting under the physician and surgeon's orders or supervision,
shall report, in writing, on a form prescribed by the board
that occurrence, within 15 days after the occurrence. The
form shall contain all of the following information:
(1) Name of the patient's physician in the outpatient setting.
(2) Name of the physician with hospital privileges.
(3) Name of the patient and patient identifying information.
(4) Name of the hospital or emergency center where the
patient was transferred.
(5) Type of outpatient procedures being performed.
(6) Events triggering the transfer.
(7) Duration of the hospital stay.
(8) Final disposition or status, if not released from the
hospital, of the patient.
(9) Physician's practice specialty and ABMS certification,
if applicable.
(c) The form described in subdivision (b) shall be constructed
in a format to enable the physician and surgeon to transmit
the information in paragraphs (5) to (9), inclusive, to
the board in a manner that the physician and surgeon and
the patient are anonymous and their identifying information
is not transmitted to the board. The entire form containing
information described in paragraphs (1) to (9), inclusive,
shall be placed in the patient's medical record.
(d) The board shall aggregate the data and publish an annual
report on the information collected pursuant to subdivisions
(a) and (b).
(e) On and after January 1, 2002, the data required in
subdivision (b) shall be sent to the Office of Statewide
Health Planning and Development (OSHPD) instead of the board.
OSHPD may revise the reporting requirements to fit state
and national standards, as applicable. The board shall work
with OSHPD in developing the reporting mechanism to satisfy
the data collection requirements of this section.
(f) The failure to comply with this section constitutes
unprofessional conduct.
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Cal Health & Saf Code § 1248
DEERING'S CALIFORNIA CODES ANNOTATED
Copyright (c) 2001 by Matthew Bender & Company, one
of the LEXIS Publishing companies.
All rights reserved.
*** THIS SECTION IS CURRENT THROUGH THE 2001 SUPPLEMENT
(2000 SESSION) ***
INCLUDING URGENCY LEGISLATION THROUGH 2001 REG. SESS. CH.
203, 8/12/01, 1ST EX. SESS. CH. 13X, 5/24/01, & 2ND
EX. SESS. CH. 2XX, 8/11/01
HEALTH AND SAFETY CODE
DIVISION 2. Licensing Provisions
CHAPTER 1.3. Outpatient Settings
§ 1248. Definitions
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.
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§ 1248.1. Required settings
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.
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§ 1248.15. Standards for accreditation of outpatient
settings
(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.
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§ 1248.2. Certificate of accreditation
(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. Denial of accreditation
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. Term of certificates; Notification of
change of ownership; Disclosure of information by agency
(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.
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§ 1248.35. Inspection by agency; Noncompliance;
Notice; Immediate suspension
(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.
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§ 1248.4. Approval of agency
(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.
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§ 1248.5. Evaluation of performance
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. Termination of approval of agency
(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.
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§ 1248.6. Fee for application for approval
(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. Unprofessional conduct to violate chapter
It shall constitute unprofessional conduct for a physician
and surgeon to willfully and knowingly violate this chapter.
§ 1248.7. Injunctions
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.
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§ 1248.75. Notice of deficiencies prior to seeking
injunction
(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.
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§ 1248.8. Violation of chapter; Misdemeanor
(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. Adoption of additional standards
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.
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THE STATE OF CALIFORNIA
BILL TEXT
STATENET
Copyright © 1999 by State Net(R), All Rights Reserved.
1999 CA A.B. 271
CALIFORNIA 1999-00 REGULAR SESSION
ASSEMBLY BILL 271
CHAPTER 944
FILED WITH SECRETARY OF STATE OCTOBER 10, 1999
APPROVED BY GOVERNOR OCTOBER 10, 1999
PASSED THE ASSEMBLY SEPTEMBER 10, 1999
PASSED THE SENATE SEPTEMBER 8, 1999
AMENDED IN SENATE SEPTEMBER 3, 1999
AMENDED IN SENATE AUGUST 25, 1999
AMENDED IN SENATE JULY 1, 1999
AMENDED IN SENATE JUNE 23, 1999
AMENDED IN ASSEMBLY MAY 6, 1999
AMENDED IN ASSEMBLY MARCH 17, 1999
INTRODUCED BY ASSEMBLY MEMBER GALLEGOS
FEBRUARY 3, 1999
1999 Bill Text CA A.B. 271
VERSION: Chaptered
VERSION-DATE: October 10, 1999
SYNOPSIS: An act to add Sections 2216.1, 2216.2,
and 2240 to the Business and Professions Code, and to amend
Section 1248.15 of the Health and Safety Code, relating
to medical care.
DIGEST:
LEGISLATIVE COUNSEL'S DIGEST
AB 271, Gallegos. Health care.
Existing law requires reports regarding personal injury
judgments and settlements involving health care providers,
and other reports of possible incompetence by health care
providers.
This bill would enact the Cosmetic and Outpatient Surgery
Patient Protection Act. This act would require any physician
and surgeon who performs a scheduled medical procedure outside
of a general acute care hospital that results in the death
or transfer to a hospital or emergency center for medical
treatment for a period exceeding 24 hours, of any patient
on whom that medical treatment was performed by the physician
and surgeon, or by a person acting under the physician and
surgeon's orders or supervision, to report, in writing,
that occurrence to the Medical Board of California within
15 days after the occurrence, as specified. It would provide
that the failure to comply with this requirement constitutes
unprofessional conduct.
The bill would also provide that, on and after July 1,
2000, it is unprofessional conduct for a physician and surgeon
to perform procedures in any outpatient setting unless the
setting has a minimum of 2 staff persons on the premises,
one of whom is either a licensed physician and surgeon or
a licensed health care professional with current certification
in advanced cardiac life support, as long as a patient is
present who has not been discharged from supervised care.
It would further provide that it is unprofessional conduct
for a physician and surgeon to fail to provide adequate
security by liability insurance or by participation in an
interindemnity trust for claims by patients arising out
of surgical procedures performed outside of a general acute
care hospital.
Existing law provides for the licensure and regulation
of health facilities. Existing law provides for the accreditation
of outpatient facilities subject to the supervision of the
Division of Licensing of the Medical Board of California.
Existing law regulates those facilities. Existing law requires
outpatient facilities to submit an emergency plan to accrediting
agencies.
This bill would require outpatient settings to post the
certificate of accreditation in a location readily visible
to patients and staff, and to 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. It would require outpatient settings
to have a written discharge criteria.
The bill would also require outpatient settings to have
a minimum of 2 staff persons on the premises, one of whom
shall be either a licensed physician and surgeon or a licensed
health care professional with current certification in advanced
cardiac life support, as long as a patient is present who
has not been discharged from supervised care. It would provide
that transfer to an unlicensed setting of a patient who
does not meet the discharge criteria shall constitute unprofessional
conduct.
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TEXT: THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT
AS FOLLOWS:
SECTION 1. This act shall be known and may be cited as
the Cosmetic and Outpatient Surgery Patient Protection Act.
SEC. 2. Section 2216.1 is added to the Business and Professions
Code, to read:
2216.1. On and after July 1, 2000, it is unprofessional
conduct for a physician and surgeon to perform procedures
in any outpatient setting except in compliance with Section
2216, unless the setting has 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.
SEC. 3. Section 2216.2 is added to the Business and Professions
Code, to read:
2216.2. (a) It is unprofessional conduct for a physician
and surgeon to fail to provide adequate security by liability
insurance, or by participation in an interindemnity trust,
for claims by patients arising out of surgical procedures
performed outside of a general acute care hospital as defined
in subdivision (a) of Section 1250 of the Health and Safety
Code.
(b) For purposes of this section, the board shall determine
what constitutes adequate security.
(c) Nothing in this section shall require an insurer admitted
to transact liability insurance in this state to provide
coverage to a physician and surgeon.
(d) The security required by this section shall be acceptable
only if provided by any one of the following:
(1) An insurer admitted pursuant to Section 700 of the
Insurance Code to transact liability insurance in this state.
(2) An insurer that appears on the list of eligible surplus
line insurers pursuant to subdivision (f) of Section 1765.1
of the Insurance Code.
(3) A cooperative corporation authorized by Section 1280.7
of the Insurance Code.
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SEC. 4. Section 2240 is added to the Business and Professions
Code, to read:
2240. (a) Any physician and surgeon who performs a scheduled
medical procedure outside of a general acute care hospital,
as defined in subdivision (a) of Section 1250 of the Health
and Safety Code, that results in the death of any patient
on whom that medical treatment was performed by the physician
and surgeon, or by a person acting under the physician and
surgeon's orders or supervision, shall report, in writing
on a form prescribed by the board, that occurrence to the
board within 15 days after the occurrence.
(b) Any physician and surgeon who performs a scheduled
medical procedure outside of a general acute care hospital,
as defined in subdivision (a) of Section 1250 of the Health
and Safety Code, that results in the transfer to a hospital
or emergency center for medical treatment for a period exceeding
24 hours, of any patient on whom that medical treatment
was performed by the physician and surgeon, or by a person
acting under the physician and surgeon's orders or supervision,
shall report, in writing, on a form prescribed by the board
that occurrence, within 15 days after the occurrence. The
form shall contain all of the following information:
(1) Name of the patient's physician in the outpatient setting.
(2) Name of the physician with hospital privileges.
(3) Name of the patient and patient identifying information.
(4) Name of the hospital or emergency center where the
patient was transferred.
(5) Type of outpatient procedures being performed.
(6) Events triggering the transfer.
(7) Duration of the hospital stay.
(8) Final disposition or status, if not released from the
hospital, of the patient.
(9) Physician's practice specialty and ABMS certification,
if applicable.
(c) The form described in subdivision (b) shall be constructed
in a format to enable the physician and surgeon to transmit
the information in paragraphs (5) to (9), inclusive, to
the board in a manner that the physician and surgeon and
the patient are anonymous and their identifying information
is not transmitted to the board. The entire form containing
information described in paragraphs (1) to (9), inclusive,
shall be placed in the patient's medical record.
(d) The board shall aggregate the data and publish an annual
report on the information collected pursuant to subdivisions
(a) and (b).
(e) On and after January 1, 2002, the data required in
subdivision (b) shall be sent to the Office of Statewide
Health Planning and Development (OSHPD) instead of the board.
OSHPD may revise the reporting requirements to fit state
and national standards, as applicable. The board shall work
with OSHPD in developing the reporting mechanism to satisfy
the data collection requirements of this section.
(f) The failure to comply with this section constitutes
unprofessional conduct.
SEC. 5. Section 1248.15 of the Health and Safety Code is
amended to read:
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.
SPONSOR:
Gallegos
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