BILL NUMBER: SB 1095	ENROLLED
	BILL TEXT

	PASSED THE SENATE  AUGUST 22, 2012
	PASSED THE ASSEMBLY  AUGUST 21, 2012
	AMENDED IN ASSEMBLY  AUGUST 6, 2012
	AMENDED IN ASSEMBLY  JUNE 25, 2012

INTRODUCED BY   Senator Rubio
   (Coauthor: Senator Wyland)

                        FEBRUARY 16, 2012

   An act to amend Sections 4190 and 4195 of, and to amend the
heading of Article 14 (commencing with Section 4190) of Chapter 9 of
Division 2 of, the Business and Professions Code, and to amend
Section 1248.35 of the Health and Safety Code, relating to pharmacy.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1095, Rubio. Pharmacy: clinics.
   Existing law, the Pharmacy Law, provides for the licensure and
regulation of the practice of pharmacy by the California State Board
of Pharmacy and makes a knowing violation of its provisions a crime.
Existing law authorizes a surgical clinic, as defined, that is
licensed by the board to purchase drugs at wholesale for
administration or dispensing, under the direction of a physician and
surgeon, to patients registered for care at the surgical clinic.
Existing law prohibits a surgical clinic from operating without a
license issued by the board. Existing law requires these surgical
clinics to comply with various regulatory requirements and to
maintain specified records. Existing law authorizes the board to
inspect a surgical clinic at any time in order to determine whether a
surgical clinic is operating in compliance with certain
requirements.
   This bill would expand these provisions to additionally authorize
an outpatient setting or an ambulatory surgical center, as specified,
to purchase drugs at wholesale for administration or dispensing,
subject to the requirements applicable to surgical clinics. The bill
would delete the requirement that a surgical clinic be licensed by
the board in order to operate. The bill would specify that the board
is authorized to inspect only an outpatient setting, an ambulatory
surgical care center, or a surgical clinic that is licensed by the
board.
   Existing law requires every outpatient setting which is accredited
to be inspected by the accreditation agency, as defined, and
authorizes an outpatient setting to be inspected by the Medical Board
of California. Existing law requires the accreditation agency to
provide the outpatient setting with notice of any deficiencies and
requires the outpatient setting to agree with the accreditation
agency on a plan of correction. Existing law requires the accrediting
agency to send a list of deficiencies and the corrective action to
the Medical Board of California. Existing law requires the
accreditation agency to report to the Medical Board of California 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. Existing law makes a willful violation of those provisions
governing outpatient settings a crime.
   This bill would additionally require the accrediting agency to
send a list of deficiencies and the corrective action to the
California State Board of Pharmacy if an outpatient setting is
licensed to purchase drugs at wholesale for administration or
dispensing, as described above. The bill would also require the
accreditation agency to report to the California State Board of
Pharmacy if an outpatient setting has been issued such a license and
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.
   Because a knowing violation of these requirements by outpatient
settings and ambulatory surgical centers, and a willful violation of
these requirements by accreditation agencies, would be a crime, the
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.


THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:

  SECTION 1.  This act shall be known and may be cited as the
California Outpatient Pharmacy Patient Safety and Improvement Act.
  SEC. 2.  The heading of Article 14 (commencing with Section 4190)
of Chapter 9 of Division 2 of the Business and Professions Code is
amended to read:

      Article 14.  Clinics


  SEC. 3.  Section 4190 of the Business and Professions Code is
amended to read:
   4190.  (a) For the purposes of this article, "clinic" means a
surgical clinic licensed pursuant to paragraph (1) of subdivision (b)
of Section 1204 of the Health and Safety Code, an outpatient setting
accredited by an accreditation agency, as defined in Section 1248 of
the Health and Safety Code, or an ambulatory surgical center
certified to participate in the Medicare Program under Title XVIII of
the federal Social Security Act (42 U.S.C. Sec. 1395 et seq.).
   (b) A clinic licensed by the board may purchase drugs at wholesale
for administration or dispensing, under the direction of a physician
and surgeon, to patients registered for care at the clinic, as
provided in subdivision (c). A separate license shall be required for
each clinic location. A clinic licensed by the board shall notify
the board of any change in the clinic's address on a form furnished
by the board. The clinic shall keep records of the kind and amounts
of drugs purchased, administered, and dispensed, and the records
shall be available and maintained for a minimum of three years for
inspection by all properly authorized personnel.
   (c) The drug distribution service of a clinic shall be limited to
the use of drugs for administration to the patients of the clinic and
to the dispensing of drugs for the control of pain and nausea for
patients of the clinic. Drugs shall not be dispensed in an amount
greater than that required to meet the patient's needs for 72 hours.
Drugs for administration shall be those drugs directly applied,
whether by injection, inhalation, ingestion, or any other means, to
the body of a patient for his or her immediate needs.
   (d) No clinic shall be entitled to the benefits of this section
until it has obtained a license from the board.
   (e) If a clinic is licensed by the board, any proposed change in
ownership or beneficial interest in the licensee shall be reported to
the board, on a form to be furnished by the board, at least 30 days
prior to the execution of any agreement to purchase, sell, exchange,
gift or otherwise transfer any ownership or beneficial interest or
prior to any transfer of ownership or beneficial interest, whichever
occurs earlier.
   (f) Nothing in this section shall limit the ability of a physician
and surgeon to prescribe, dispense, administer, or furnish drugs at
a clinic as provided in Sections 2241.5, 2242, and 4170.
  SEC. 4.  Section 4195 of the Business and Professions Code is
amended to read:
   4195.  The board shall have the authority to inspect a clinic that
is licensed pursuant to this article at any time in order to
determine whether the clinic is, or is not, operating in compliance
with this article and all other provisions of the law.
  SEC. 5.  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) 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. 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.