BILL NUMBER: SB 396 CHAPTERED
BILL TEXT
CHAPTER 287
FILED WITH SECRETARY OF STATE SEPTEMBER 9, 2015
APPROVED BY GOVERNOR SEPTEMBER 9, 2015
PASSED THE SENATE AUGUST 27, 2015
PASSED THE ASSEMBLY AUGUST 20, 2015
AMENDED IN ASSEMBLY JUNE 29, 2015
AMENDED IN SENATE MAY 5, 2015
AMENDED IN SENATE APRIL 22, 2015
AMENDED IN SENATE APRIL 14, 2015
INTRODUCED BY Senator Hill
FEBRUARY 25, 2015
An act to amend Section 805.5 of the Business and Professions
Code, to amend Section 12529.7 of the Government Code, and to amend
Sections 1248.15 and 1248.35 of the Health and Safety Code, relating
to health care.
LEGISLATIVE COUNSEL'S DIGEST
SB 396, Hill. Health care: outpatient settings and surgical
clinics: facilities: licensure and enforcement.
The Medical Practice Act provides for the licensure and regulation
of physicians and surgeons by the Medical Board of California.
Existing law provides that it is unprofessional conduct for a
physician and surgeon to perform procedures in any outpatient setting
except in compliance with specified provisions. Existing law
prohibits an association, corporation, firm, partnership, or person
from operating, managing, conducting, or maintaining an outpatient
setting in the state unless the setting is one of the specified
settings, which include, among others, an ambulatory surgical clinic
that is certified to participate in the Medicare Program, a surgical
clinic licensed by the State Department of Public Health, or an
outpatient setting accredited by an accreditation agency approved by
the Division of Licensing of the Medical Board of California.
Existing law provides that an outpatient setting that is
accredited shall be inspected by the accreditation agency and may be
inspected by the Medical Board of California. Existing law requires
that the inspections be conducted no less often than once every 3
years by the accreditation agency and as often as necessary by the
Medical Board of California to ensure quality of care provided.
This bill would authorize the accrediting agency to conduct
unannounced inspections subsequent to the initial inspection for
accreditation, if the accreditation agency provides specified notice
of the unannounced routine inspection to the outpatient setting.
Existing law requires members of the medical staff and other
practitioners who are granted clinical privileges in an outpatient
setting to be professionally qualified and appropriately credentialed
for the performance of privileges granted and requires the
outpatient setting to grant privileges in accordance with
recommendations from qualified health professionals, and
credentialing standards established by the outpatient setting. A
willful violation of these provisions is a crime.
This bill would additionally require that each licensee who
performs procedures in an outpatient setting that requires the
outpatient setting to be accredited be peer reviewed, as specified,
at least every 2 years, by licensees who are qualified by education
and experience to perform the same types of, or similar, procedures.
The bill would require the findings of the peer review to be reported
to the governing body, which shall determine if the licensee
continues to be professionally qualified and appropriately
credentialed for the performance of privileges granted. By expanding
the scope of a crime, this bill would impose a state-mandated local
program.
Existing law requires specified entities, including any health
care service plan or medical care foundation, to request a report
from the Medical Board of California, the Board of Psychology, the
Osteopathic Medical Board of California, or the Dental Board of
California, prior to granting or renewing staff privileges, to
determine if a certain report has been made indicating that the
applying physician and surgeon, psychologist, podiatrist, or dentist
has been denied staff privileges, been removed from a medical staff,
or had his or her staff privileges restricted.
This bill would also require an outpatient setting and a facility
certified to participate in the federal Medicare Program as an
ambulatory surgical center to request that report. By expanding the
scope of a crime, this bill would impose a state-mandated local
program.
Existing law establishes a vertical enforcement and prosecution
model for cases before the Medical Board of California, and requires
the board to report to the Governor and the Legislature on that model
by March 1, 2015.
This bill would extend the date that report is due to March 1,
2016.
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.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 805.5 of the Business and Professions Code is
amended to read:
805.5. (a) Prior to granting or renewing staff privileges for any
physician and surgeon, psychologist, podiatrist, or dentist, any
health facility licensed pursuant to Division 2 (commencing with
Section 1200) of the Health and Safety Code, any health care service
plan or medical care foundation, the medical staff of the
institution, a facility certified to participate in the federal
Medicare Program as an ambulatory surgical center, or an outpatient
setting accredited pursuant to Section 1248.1 of the Health and
Safety Code shall request a report from the Medical Board of
California, the Board of Psychology, the Osteopathic Medical Board of
California, or the Dental Board of California to determine if any
report has been made pursuant to Section 805 indicating that the
applying physician and surgeon, psychologist, podiatrist, or dentist
has been denied staff privileges, been removed from a medical staff,
or had his or her staff privileges restricted as provided in Section
805. The request shall include the name and California license number
of the physician and surgeon, psychologist, podiatrist, or dentist.
Furnishing of a copy of the 805 report shall not cause the 805 report
to be a public record.
(b) Upon a request made by, or on behalf of, an institution
described in subdivision (a) or its medical staff the board shall
furnish a copy of any report made pursuant to Section 805 as well as
any additional exculpatory or explanatory information submitted
electronically to the board by the licensee pursuant to subdivision
(f) of that section. However, the board shall not send a copy of a
report (1) if the denial, removal, or restriction was imposed solely
because of the failure to complete medical records, (2) if the board
has found the information reported is without merit, (3) if a court
finds, in a final judgment, that the peer review, as defined in
Section 805, resulting in the report was conducted in bad faith and
the licensee who is the subject of the report notifies the board of
that finding, or (4) if a period of three years has elapsed since the
report was submitted. This three-year period shall be tolled during
any period the licentiate has obtained a judicial order precluding
disclosure of the report, unless the board is finally and permanently
precluded by judicial order from disclosing the report. If a request
is received by the board while the board is subject to a judicial
order limiting or precluding disclosure, the board shall provide a
disclosure to any qualified requesting party as soon as practicable
after the judicial order is no longer in force.
If the board fails to advise the institution within 30 working
days following its request for a report required by this section, the
institution may grant or renew staff privileges for the physician
and surgeon, psychologist, podiatrist, or dentist.
(c) Any institution described in subdivision (a) or its medical
staff that violates subdivision (a) is guilty of a misdemeanor and
shall be punished by a fine of not less than two hundred dollars
($200) nor more than one thousand two hundred dollars ($1,200).
SEC. 2. Section 12529.7 of the Government Code is amended to read:
12529.7. By March 1, 2016, the Medical Board of California, in
consultation with the Department of Justice and the Department of
Consumer Affairs, shall report and make recommendations to the
Governor and the Legislature on the vertical enforcement and
prosecution model created under Section 12529.6.
SEC. 3. 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 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) 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) 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 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) (i) 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.
(ii) Each licensee who performs procedures in an outpatient
setting that requires the outpatient setting to be accredited shall
be, at least every two years, peer reviewed, which shall be a process
in which the basic qualifications, staff privileges, employment,
medical outcomes, or professional conduct of a licensee is reviewed
to make recommendations for quality improvement and education, if
necessary, including when the outpatient setting has only one
licensee. The peer review shall be performed by licensees who are
qualified by education and experience to perform the same types of,
or similar, procedures. The findings of the peer review shall be
reported to the governing body, which shall determine if the licensee
continues to meet the requirements described in clause (i). The
process that resulted in the findings of the peer review shall be
reviewed by the accrediting agency at the next survey to determine if
the outpatient setting meets applicable accreditation standards
pursuant to this section.
(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.
SEC. 4. Section 1248.35 of the Health and Safety Code is amended
to read:
1248.35. (a) Every outpatient setting that 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. After the initial inspection for accreditation, subsequent
inspections may be unannounced. For unannounced routine inspections,
the accreditation agency shall notify the outpatient setting that the
inspection will occur within 60 days.
(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) 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 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 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 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 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 may include a recommendation for reinspection. All final
inspection reports, 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. 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. 5. 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.