the
below sourced in part at
http://www.leginfo.ca.gov/cgi-bin/displaycode?section=bpc&group=02001-03000&file=2215-2217
BUSINESS
AND PROFESSIONS CODE
SECTION 2215-2217
2215. 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. 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 antibiotics 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. 2217. 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.
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. (b) 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.
(c) 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
healthcare 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.
New California Law
Concern about OFFICE SURGERY
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