BILL NUMBER: SB 701 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Emmerson
FEBRUARY 22, 2013
An act to amend Sections 1248, 1248.15, 1248.35, 1248.4, and
1248.5 of the Health and Safety Code, relating to outpatient
facilities.
LEGISLATIVE COUNSEL'S DIGEST
SB 701, as introduced, Emmerson. Hospital-affiliated outpatient
settings.
Existing law requires the Medical Board of California to adopt
standards for accreditation of outpatient settings, as defined, and,
in approving accreditation agencies to perform this accreditation, to
ensure that the certification program shall, at a minimum, include
standards for specified aspects of the settings' operations. Existing
law makes a willful violation of these and other provisions relating
to outpatient settings a crime.
This bill would create entities known as hospital-affiliated
outpatient settings, as defined, and would align the accreditation
and reporting processes with those of the general acute care hospital
with which the hospital-affiliated outpatient settings is
affiliated. By expanding the definition of a crime, this bill would
impose a state-mandated local program.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1248 of the Health and Safety Code is amended
to read:
1248. For purposes of this chapter, the following definitions
shall apply:
(a) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the Medical Board of California pursuant to Sections
1248.15 and 1248.4.
(b) "Deemed accreditation agency" means a national accreditation
program meeting the requirements of, and approved for, deeming
authority for Medicare requirements by the United States Department
of Health and Human Services, the Centers for Medicare and Medicaid
Services, or any successor agency.
(a)
(c) "Division" means the Medical Board of California.
All references in this chapter to the division, the Division of
Licensing of the Medical Board of California, or the Division of
Medical Quality shall be deemed to refer to the Medical Board of
California pursuant to Section 2002 of the Business and Professions
Code.
(d) "Hospital-affiliated outpatient setting" means a facility,
clinic, unlicensed clinic, center, office, or other setting that is
an outpatient setting, does not operate exclusively for the purpose
of providing surgical services to patients not requiring
hospitalization and in which the expected duration of services would
not exceed 24 hours following admission, and is accredited by a
deemed accreditation agency as part of a general acute care hospitals'
s accreditation process.
(b)
(e) (1) "Outpatient setting" means any facility,
clinic, unlicensed clinic, center, office, or other setting that is
not part of a general acute care facility, as defined in Section
1250, and where anesthesia, except local anesthesia or peripheral
nerve blocks, or both, is used in compliance with the community
standard of practice, in doses that, when administered have the
probability of placing a patient at risk for loss of the patient's
life-preserving protective reflexes.
(2) "Outpatient setting" also means facilities that offer in vitro
fertilization, as defined in subdivision (b) of Section 1374.55.
(3) "Outpatient setting" does not include, among other settings,
any setting where anxiolytics and analgesics are administered, when
done so in compliance with the community standard of practice, in
doses that do not have the probability of placing the patient at risk
for loss of the patient's life-preserving protective reflexes.
(c) "Accreditation agency" means a public or private organization
that is approved to issue certificates of accreditation to outpatient
settings by the board pursuant to Sections 1248.15 and 1248.4.
(4) "Outpatient setting" also means a hospital-affiliated setting,
except as otherwise indicated.
SEC. 2. Section 1248.15 of the Health and Safety Code is amended
to read:
1248.15. (a) The board shall adopt standards for accreditation
and, in approving accreditation agencies to perform accreditation of
outpatient settings, shall ensure that the certification program
shall, at a minimum, include standards for the following aspects of
the settings' operations:
(1) Outpatient setting allied health staff shall be licensed or
certified to the extent required by state or federal law.
(2) (A) Outpatient settings shall have a system for facility
safety and emergency training requirements.
(B) There shall be onsite equipment, medication, and trained
personnel to facilitate handling of services sought or provided and
to facilitate handling of any medical emergency that may arise in
connection with services sought or provided.
(C) In order for procedures to be performed in an outpatient
setting that is not a hospital-affiliated 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) In addition to the requirements imposed in subparagraph (C),
the outpatient setting shall submit for approval by an accreditation
agency at the time of accreditation a detailed plan, standardized
procedures, and protocols to be followed in the event of serious
complications or side effects from surgery that would place a patient
at high risk for injury or harm or to govern emergency and urgent
care situations. The plan shall include, at a minimum, that if a
patient is being transferred to a local accredited or licensed acute
care hospital, the outpatient setting shall do all of the following:
(i) Notify the individual designated by the patient to be notified
in case of an emergency.
(ii) Ensure that the mode of transfer is consistent with the
patient's medical condition.
(iii) Ensure that all relevant clinical information is documented
and accompanies the patient at the time of transfer.
(iv) Continue to provide appropriate care to the patient until the
transfer is effectuated.
(E) (i) All physicians and surgeons
transferring patients from an outpatient setting that is not a
hospital-affiliated outpatient setting shall agree to cooperate
with the medical staff peer review process on the transferred case,
the results of which shall be referred back to the outpatient
setting, if deemed appropriate by the medical staff peer review
committee. If the medical staff of the acute care facility determines
that inappropriate care was delivered at the outpatient setting, the
acute care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body or in accordance with existing
law.
(ii) All physicians and surgeons transferring patients from a
hospital-affiliated 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 general acute care
facility, if deemed appropriate by the medical staff peer review
committee. If the medical staff of the acute care facility determines
that inappropriate care was delivered at the outpatient setting, the
acute care facility's peer review outcome shall be reported, as
appropriate, to the accrediting body or in accordance with existing
law.
(3) The outpatient setting shall permit surgery by a dentist
acting within his or her scope of practice under Chapter 4
(commencing with Section 1600) of Division 2 of the Business and
Professions Code or physician and surgeon, osteopathic physician and
surgeon, or podiatrist acting within his or her scope of practice
under Chapter 5 (commencing with Section 2000) of Division 2 of the
Business and Professions Code or the Osteopathic Initiative Act. The
outpatient setting may, in its discretion, permit anesthesia service
by a certified registered nurse anesthetist acting within his or her
scope of practice under Article 7 (commencing with Section 2825) of
Chapter 6 of Division 2 of the Business and Professions Code.
(4) Outpatient settings shall have a system for maintaining
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 shall have all of the sites inspected.
(8) Outpatient settings shall post the certificate of
accreditation in a location readily visible to patients and staff.
(9) Outpatient settings shall post the name and telephone number
of the accrediting agency with instructions on the submission of
complaints in a location readily visible to patients and staff.
(10) Outpatient settings shall have a written discharge criteria.
(b) Outpatient settings shall have a minimum of two staff persons
on the premises, one of whom shall either be a licensed physician and
surgeon or a licensed health care professional with current
certification in advanced cardiac life support (ACLS), as long as a
patient is present who has not been discharged from supervised care.
Transfer to an unlicensed setting of a patient who does not meet the
discharge criteria adopted pursuant to paragraph (10) of subdivision
(a) shall constitute unprofessional conduct.
(c) An accreditation agency may include additional standards in
its determination to accredit outpatient settings if these are
approved by the board to protect the public health and safety.
(d) No accreditation standard adopted or approved by the board,
and no standard included in any certification program of any
accreditation agency approved by the board, shall serve to limit the
ability of any allied health care practitioner to provide services
within his or her full scope of practice. Notwithstanding this or any
other provision of law, each outpatient setting may limit the
privileges, or determine the privileges, within the appropriate scope
of practice, that will be afforded to physicians and allied health
care practitioners who practice at the facility, in accordance with
credentialing standards established by the outpatient setting in
compliance with this chapter. Privileges may not be arbitrarily
restricted based on category of licensure.
(e) The board shall adopt standards that it deems necessary for
outpatient settings that offer in vitro fertilization.
(f) The board may adopt regulations it deems necessary to specify
procedures that should be performed in an accredited outpatient
setting for facilities or clinics that are outside the definition of
outpatient setting as specified in Section 1248.
(g) As part of the accreditation process, the accrediting agency
shall conduct a reasonable investigation of the prior history of the
outpatient setting, including all licensed physicians and surgeons
who have an ownership interest therein, to determine whether there
have been any adverse accreditation decisions rendered against them.
For the purposes of this section, "conducting a reasonable
investigation" means querying the Medical Board of California and the
Osteopathic Medical Board of California to ascertain if either the
outpatient setting has, or, if its owners are licensed physicians and
surgeons, if those physicians and surgeons have, been subject to an
adverse accreditation decision. This subdivision shall not apply
to hospital-affiliated outpatient settings.
(h) (1) An outpatient setting shall be
subject to the reporting requirements in Section 1279.1 and the
penalties for failure to report specified in Section 1280.4.
This paragraph shall not apply to adverse events described in
subparagraph (E) of paragraph (1) of subdivision (b) of Section
1279.1 that occur in a hospital-affiliated outpatient setting.
(2) The general acute care hospital affiliated with the
hospital-affiliated outpatient setting shall report any adverse event
described in subparagraph (E) of paragraph (1) of subdivision (b) of
Section 1279.1 that occurs in a hospital-affiliated outpatient
setting, subject to reporting requirements in Section 1279.1 and
penalties for failure to report in Section 1280.4.
SEC. 3. Section 1248.35 of the Health and Safety Code is amended
to read:
1248.35. (a) Every outpatient setting which is accredited shall
be inspected by the accreditation agency and may also be inspected by
the Medical Board of California. The Medical Board of California
shall ensure that accreditation agencies inspect outpatient settings.
(b) Unless otherwise specified, the following requirements apply
to inspections described in subdivision (a).
(1) The frequency of inspection shall depend upon the type and
complexity of the outpatient setting to be inspected.
(2) Inspections shall be conducted no less often than once every
three years by the accreditation agency and as often as necessary by
the Medical Board of California to ensure the quality of care
provided.
(3) The Medical Board of California or the accreditation agency
may enter and inspect any outpatient setting that is accredited by an
accreditation agency at any reasonable time to ensure compliance
with, or investigate an alleged violation of, any standard of the
accreditation agency or any provision of this chapter.
(c) If an accreditation agency determines, as a result of its
inspection, that an outpatient setting is not in compliance with the
standards under which it was approved, the accreditation agency may
do any of the following:
(1) Require correction of any identified deficiencies within a set
timeframe. Failure to comply shall result in the accrediting agency
issuing a reprimand or suspending or revoking the outpatient setting'
s accreditation.
(2) Issue a reprimand.
(3) Place the outpatient setting on probation, during which time
the setting shall successfully institute and complete a plan of
correction, approved by the board or the accreditation agency, to
correct the deficiencies.
(4) Suspend or revoke the outpatient setting's certification of
accreditation.
(d) (1) (A) 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 that is not a hospital-affiliated
outpatient setting with notice of any deficiencies and the
outpatient setting shall agree with the accreditation agency on a
plan of correction that shall give the outpatient setting reasonable
time to supply information demonstrating compliance with the
standards of the accreditation agency in compliance with this
chapter, as well as the opportunity for a hearing on the matter upon
the request of the outpatient setting. During
(B) Except as otherwise provided in this subdivision, before
suspending or revoking a certificate of accreditation under this
chapter, the deemed accreditation agency shall provide the hospital
that is affiliated with the hospital-affiliated outpatient setting
with notice of any deficiencies, which may be combined with notice of
other deficiencies for the hospital's general acute care
accreditation. The hospital shall agree with the accreditation agency
on a plan of correction that shall give the hospital 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 if the hospital
requests one.
(C) During the allotted time to
correct the deficiencies, the plan of correction, which includes the
deficiencies, shall be conspicuously posted by the outpatient setting
in a location accessible to public view. Within
(D) Within 10 days after the
adoption of the plan of correction, the accrediting agency shall send
a list of deficiencies and the corrective action to be taken to the
board and to the California State Board of Pharmacy if an outpatient
setting is licensed pursuant to Article 14 (commencing with Section
4190) of Chapter 9 of Division 2 of the Business and Professions
Code. The If the outpatient
setting is a hospital-affiliated outpatient setting, the list of
deficiencies and the corrective action to be taken may be combined
with the list of deficiencies and the corrective action to be taken
for the hospital's general acute care accreditation that directly
affect the hospital-affiliated outpatient setting.
(E) The accreditation agency may
immediately suspend the certificate of accreditation before providing
notice and an opportunity to be heard, but only when failure to take
the action may result in imminent danger to the health of an
individual. In such cases, the accreditation agency shall provide
subsequent notice and an opportunity to be heard.
(2) If an outpatient setting does not comply with a corrective
action within a timeframe specified by the accrediting agency, the
accrediting agency shall issue a reprimand, and may either place the
outpatient setting on probation or suspend or revoke the
accreditation of the outpatient setting, and shall notify the board
of its action. This section shall not be deemed to prohibit an
outpatient setting that is unable to correct the deficiencies, as
specified in the plan of correction, for reasons beyond its control,
from voluntarily surrendering its accreditation prior to initiation
of any suspension or revocation proceeding.
(e) The accreditation agency shall, within 24 hours, report to the
board if the outpatient setting has been issued a reprimand or if
the outpatient setting's certification of accreditation has been
suspended or revoked or if the outpatient setting has been placed on
probation. If an outpatient setting has been issued a license by the
California State Board of Pharmacy pursuant to Article 14 (commencing
with Section 4190) of Chapter 9 of Division 2 of the Business and
Professions Code, the accreditation agency shall also send this
report to the California State Board of Pharmacy within 24 hours.
(f) The accreditation agency, upon receipt of a complaint from the
board that an outpatient setting poses an immediate risk to public
safety, shall inspect the outpatient setting and report its findings
of inspection to the board within five business days. If an
accreditation agency receives any other complaint from the board, it
shall investigate the outpatient setting and report its findings of
investigation to the board within 30 days.
(g) Reports on the results of any inspection shall be kept on file
with the board and the accreditation agency along with the plan of
correction and the comments of the outpatient setting. The
inspection report for an outpatient setting that is not a
hospital-affiliated outpatient setting shall include the lists of
deficiencies, plans of correction or requirements for improvements
and correction, and corrective action completed. The inspection
report for a hospital-affiliat ed outpatient setting shall
include a letter from the deemed accreditation agency stating the
accreditation status of the hospital-affiliated outpatient setting.
The inspection report may include a recommendation for
reinspection. All final inspection reports for outpatient
settings as defined in subdivision (e) of Section 1248 , which
include the lists of deficiencies, plans of correction or
requirements for improvements and correction, and corrective action
completed, shall be public records open to public inspection.
(h) If one accrediting agency denies accreditation, or revokes or
suspends the accreditation of an outpatient setting, this action
shall apply to all other accrediting agencies. An outpatient setting
that is denied accreditation is permitted to reapply for
accreditation with the same accrediting agency. The outpatient
setting also may apply for accreditation from another accrediting
agency, but only if it discloses the full accreditation report of the
accrediting agency that denied accreditation. If a deemed
accreditation agency denies accreditation and the outpatient setting
seeks to apply for accreditation from another accrediting agency, the
outpatient setting shall also disclose the lists of deficiencies,
plans of correction or requirements for improvements and
correction, and corrective action completed from the deemed
accreditation agency that denied accreditation. Any outpatient
setting that has been denied accreditation shall disclose the
accreditation report to any other accrediting agency to which it
submits an application. The new accrediting agency shall ensure that
all deficiencies have been corrected and conduct a new onsite
inspection consistent with the standards specified in this chapter.
(i) If an outpatient setting's certification of accreditation has
been suspended or revoked, or if the accreditation has been denied,
the accreditation agency shall do all of the following:
(1) Notify the board of the action.
(2) Send a notification letter to the outpatient setting of the
action. The notification letter shall state that the setting is no
longer allowed to perform procedures that require outpatient setting
accreditation.
(3) Require the outpatient setting to remove its accreditation
certification and to post the notification letter in a conspicuous
location, accessible to public view.
(j) The board may take any appropriate action it deems necessary
pursuant to Section 1248.7 if an outpatient setting's certification
of accreditation has been suspended or revoked, or if accreditation
has been denied.
SEC. 4. Section 1248.4 of the Health and Safety Code is amended to
read:
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
, except that paragraph (6) shall not apply to an
accreditation agency for hospital-affiliated outpatient settin
gs :
(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) In lieu of the requirements of paragraph (6),
hospital-affiliated outpatient settings shall be reviewed by
physicians and surgeons or clinicians educated through formal
training programs provided by a deemed accreditation organization.
Members of the team shall participate in the training programs at
least every three years.
(7)
(8) The accreditation agency shall demonstrate that
professional members of its review team have experience in conducting
review activities of freestanding outpatient settings.
(8)
(9) Standards for accreditation shall be developed with
the input of the medical community and the ambulatory surgery
industry.
(9)
(10) Accreditation reviewers shall be credentialed and
screened by the accreditation agency.
(10)
(11) 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) Notwithstanding subdivision (c) and Section 1248.15, this
division shall approve any deemed accreditation agency to perform
certification of any hospital-affiliated outpatient setting that
applies for approval, accompanied by both of the following:
(1) A letter by the deemed accreditation agency that it shall
comply with this chapter with respect to the
certification of a hospital-affiliated
outpatient setting.
(2) Evidence that the certification program includes standards for
policies and procedures addressing the indication and management of
sedation.
(d)
(e) 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)
(f) 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.
SEC. 5. Section 1248.5 of the Health and Safety Code is amended to
read:
1248.5. The board shall evaluate the performance of an approved
accreditation agency no less than every three years, or in response
to complaints against an agency, or complaints against one or more
outpatient settings accreditation by an agency that indicates
noncompliance by the agency with the standards approved by the board.
This section shall not apply to a deemed accreditation agency
that is approved solely pursuant to subdivision (d) of Section
1248.4.
SEC. 6. No reimbursement is required by this act pursuant to
Section 6 of Article XIII B of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIII B of the California
Constitution.