Senate Bill No. 701

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:

begin insert

(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.

end insert begin insert

(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.

end insert begin delete

(a)

end delete

begin insert (c) end insert  “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.

begin insert

(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.

end insert begin delete

(b)

end delete

begin insert (e) end insert  (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.

begin delete

(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.

end delete begin insert

(4) “Outpatient setting” also means a hospital-affiliated setting,
except as otherwise indicated.

end insert

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 begin insert that is not a hospital-affiliated outpatient setting end insert 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)  begin insert (i) end insert begin insert   end insert All physicians and surgeons transferring patients from
an outpatient setting begin insert that is not a hospital-affiliated outpatient
setting end insert 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.

begin insert

(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.

end insert

(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. begin insert This subdivision
shall not apply to hospital-affiliated outpatient settings. end insert

(h)  begin insert (1) end insert begin insert   end insert 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. begin insert 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. end insert

begin insert

(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.

end insert

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)  begin insert (A) end insert begin insert   end insert 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 begin insert that is not a hospital-affiliated outpatient setting end insert 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. begin delete During end delete

begin insert

(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.

end insert

begin insert (C) end insert begin insert   end insert begin insert During end insert 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. begin delete Within end delete

begin insert (D) end insert begin insert   end insert begin insert Within end insert 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. begin delete The end delete begin insert 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. end insert

begin insert (E) end insert begin insert   end insert begin insert The end insert 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. begin insert 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-affiliated outpatient setting shall include a
letter from the deemed accreditation agency stating the
accreditation status of the hospital-affiliated outpatient setting. end insert
The inspection report may include a recommendation for
reinspection. All final inspection reports begin insert for outpatient settings as
defined in subdivision (e) of Section 1248 end insert , 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. begin insert 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. end insert 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 begin insert ,
except that paragraph (6) shall not apply to an accreditation
agency for hospital-affiliated outpatient settings end insert :

(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.

begin insert

(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.

end insert begin delete

(7)

end delete

begin insert (8) end insert  The accreditation agency shall demonstrate that professional
members of its review team have experience in conducting review
activities of freestanding outpatient settings.

begin delete

(8)

end delete

begin insert (9) end insert  Standards for accreditation shall be developed with the input
of the medical community and the ambulatory surgery industry.

begin delete

(9)

end delete

begin insert (10) end insert  Accreditation reviewers shall be credentialed and screened
by the accreditation agency.

begin delete

(10)

end delete

begin insert (11) end insert  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.

begin insert

(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:

end insert begin insert

(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.

end insert begin insert

(2) Evidence that the certification program includes standards
for policies and procedures addressing the indication and
management of sedation.

end insert begin delete

(d)

end delete

begin insert (e) end insert  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.

begin delete

(e)

end delete

begin insert (f) end insert  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. begin insert This section shall not apply to a deemed accreditation
agency that is approved solely pursuant to subdivision (d) of
Section 1248.4. end insert

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.