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New California Law
Concern about OFFICE SURGERY
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 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. 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.
the above was sourced in part at
http://www.leginfo.ca.gov/cgi-bin/displaycode?section=bpc&group=02001-03000&file=2215-2217
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