Amended in Assembly June 20, 2013

Amended in Senate May 7, 2013

Amended in Senate April 18, 2013

Senate Bill No. 306

Introduced by Senator begin delete Price end delete begin insert Torres end insert

(Principal coauthor: Assembly Member begin delete Gordon end delete begin insert Cooley end insert )

February 15, 2013

An act to amend Sections begin delete 1000, 2530.2, 2531, 2531.75, 2533, 2570.19, 2602, and 2607.5 end delete begin insert 4170, 4180, and 4186 end insert of the Business and Professions Code, relating to begin delete healing arts end delete begin insert pharmacy end insert .

LEGISLATIVE COUNSEL’S DIGEST

SB 306, as amended, begin delete Price end delete   begin insert Torres end insert . begin delete Healing arts: boards. end delete begin insert Pharmacy: dangerous drugs and dangerous devices: automated drug delivery systems. end insert

begin insert

Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacies in this state by the California State Board of Pharmacy. A violation of the Pharmacy Law is a crime.

end insert begin insert

Among other provisions, the Pharmacy Law prohibits a prescriber from dispensing dangerous drugs or dangerous devices, as defined, to patients in his or her office unless specified conditions are met. Existing law defines a prescriber for purposes of this provision to mean a person who holds a physician’s and surgeon’s certificate, or one of other specified health care licenses or certificates, and who is registered to engage in that practice with the appropriate board of this state. Existing law authorizes certain health care professionals, including a certified nurse-midwife or a nurse practitioner, as specified, to hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer, as defined, or a pharmacist.

end insert begin insert

This bill would revise the conditions under which a prescriber may dispense dangerous drugs and dangerous devices. The bill would require a health care professional who is licensed as specified, or his or her designee, to physically furnish the dangerous drug or device to the patient, to be identified, except as specified, by the drug or device manufacturer or wholesaler supplying the drug or device as the recipient of the drug or device, and as the recipient in all invoices, bills of lading, state or federal order forms, and other documentation, and to provide the patient with an oral consultation, as specified. The bill would revise the definition of a prescriber to apply to a person who is licensed to prescribe and dispense dangerous drugs, including, but not limited to, the licensed health care professionals authorized pursuant to existing law. The bill would also authorize a registered nurse who functions within a licensed primary care clinic, federal or state government operated clinic, community or free clinic to hand to a patient of the supervising physician and surgeon a properly labeled prescription drug prepackaged by a physician and surgeon, a manufacturer, as defined, or a pharmacist.

end insert begin insert

Existing law authorizes clinics to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon, to patients registered for care at the clinic. Existing law also authorizes an automated drug delivery system, as defined, to be located in any clinic licensed by the board, as specified. Existing law requires an automated drug delivery system to collect, control, and maintain all transaction information to accurately track the movement of drugs into and out of the system for security, accuracy, and accountability.

end insert begin insert

This bill would authorize an automated drug delivery to be located in a group practice, as specified. The bill would authorize specified entities, including a group practice, that uses an automated drug delivery system, as described, to purchase drugs at wholesale for administration or dispensing, under the direction of a physician and surgeon or other prescriber when permitted by law, and would make conforming and related changes.

end insert begin insert

The bill would also impose new conditions on an automated drug delivery system. Among other requirements, the bill would require that an automated drug delivery system be located within the clinic or office of the group practice, that its contents be secure from access or removal by unauthorized individuals, and that it maintain a readily retrievable electronic record to identify all pharmacists, registered pharmacy technicians, prescribers, and all other personnel involved in the dispensing of a drug. The bill would also require that the record of transactions conducted through the automated drug delivery system be made available to authorized agents of the board. The bill would authorize the board to adopt regulations permitting the use of an automated drug delivery system that delivers dispensed medications directly to a patient.

end insert begin insert

Because of violation of the bill’s requirements would be a crime, the bill would impose a state-mandated local program.

end insert begin insert

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.

end insert begin insert

This bill would provide that no reimbursement is required by this act for a specified reason.

end insert begin delete

The Chiropractic Act, enacted by an initiative measure, provides for the regulation and licensing of chiropractors in this state by the State Board of Chiropractic Examiners. Existing law specifies that the law governing chiropractors is found in the act.

end delete begin delete

This bill would require that the powers and duties of the board, as provided, be subject to review by the appropriate policy committees of the Legislature. The bill would require that the review of the board be performed as if these provisions were scheduled to be repealed on January 1, 2018.

end delete begin delete

Existing law, the Speech-Language Pathologists and Audiologists and Hearing Aid Dispensers Licensure Act, provides for the licensure and regulation of speech-language pathologists, audiologists, and hearing aid dispensers by the Speech-Language Pathology and Audiology and Hearing Aid Dispensers Board. The act authorizes the board to appoint an executive officer. Existing law repeals these provisions on January 1, 2014, and subjects the board to review by the Joint Committee on Boards, Commissions, and Consumer Protection.

end delete begin delete

This bill would extend the operation of these provisions until January 1, 2018, and provide that the repeal of these provisions subjects the board to review by the appropriate policy committees of the Legislature.

end delete begin delete

The Speech-Language Pathologists and Audiologists and Hearing Aid Dispensers Licensure Act also authorizes the board to refuse to issue, or issue subject to terms and conditions, a license on specified grounds, including, among others, securing a license by fraud or deceit.

end delete begin delete

This bill would additionally authorize the board to refuse to issue, or issue subject to terms and conditions, a license for a violation of a term or condition of a probationary order of a license issued by the board, as provided.

end delete begin delete

Existing law, the Occupational Therapy Practice Act, provides for the licensure and regulation of occupational therapists, as defined, by the California Board of Occupational Therapy. Existing law repeals those provisions on January 1, 2014, and subjects the board to review by the Joint Committee on Boards, Commissions, and Consumer Protection.

end delete begin delete

This bill would extend the operation of these provisions until January 1, 2018, and provide that the repeal of these provisions subjects the board to review by the appropriate policy committees of the Legislature.

end delete begin delete

Existing law, the Physical Therapy Practice Act, provides for the licensure and regulation of physical therapists by the Physical Therapy Board of California. The act authorizes the board to appoint an executive officer. Existing law repeals these provisions on January 1, 2014.

end delete begin delete

This bill would extend the operation of these provisions until January 1, 2018.

end delete

Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program:  begin delete no end delete begin insert yes end insert .

The people of the State of California do enact as follows:

begin insert

begin insert SECTION 1 end insert begin insert . end insert   

end insert

begin insert Section 4170 of the end insert begin insert Business and Professions
Code end insert begin insert is amended to read: end insert

4170.  

(a) No prescriber shall dispense begin insert dangerous end insert drugs or
dangerous devices to patients in his or her office or place of
practice unless all of the following conditions are met:

(1) The dangerous drugs or dangerous devices are dispensed to
the prescriber’s own begin delete patient, and the drugs or dangerous devices
are not furnished by a nurse or physician attendant end delete begin insert patient. A health
care professional who is licensed as described in this section, or
his or her designee, shall physically furnish the dangerous drug
or device to the patient end insert .

(2) The dangerous drugs or dangerous devices are necessary in
the treatment of the condition for which the prescriber is attending
the patient.

(3) The prescriber does not keep a pharmacy, open shop, or
drugstore, advertised or otherwise, for the retailing of dangerous
drugs, dangerous devices, or poisons.

(4) The prescriber fulfills all of the labeling requirements
imposed upon pharmacists by Section 4076, all of the
recordkeeping requirements of this chapter, and all of the packaging
requirements of good pharmaceutical practice, including the use
of childproof containers.

begin delete

(5) The prescriber does not use a dispensing device unless he
or she personally owns the device and the contents of the device,
and personally dispenses the dangerous drugs or dangerous devices
to the patient packaged, labeled, and recorded in accordance with
paragraph (4).

end delete begin insert

(5) Unless the prescriber is employed by or under contract to
a clinic or group practice that is licensed by the board pursuant
to Section 4180, the prescriber is identified by the drug
manufacturer or wholesaler supplying the drugs as the recipient
of the drugs and identified by name and registration number as
the recipient in all invoices, bills of lading, state or federal order
forms, and other documentation. As the recipient of the drugs, the
prescriber is responsible for ensuring that the drugs are securely
and safely stored prior to dispensing and is responsible for
maintaining all required records regarding the receipt, storage,
and dispensing or other disposition of all drugs and devices.

end insert

(6) The prescriber, prior to dispensing, offers to give a written
prescription to the patient that the patient may elect to have filled
by the prescriber or by any pharmacy.

(7) The prescriber provides the patient with written disclosure
that the patient has a choice between obtaining the prescription
from the dispensing prescriber or obtaining the prescription at a
pharmacy of the patient’s choice.

begin insert

(8) The prescriber provides the patient with an oral consultation
regarding issues that the prescriber, in his or her professional
judgment, deems necessary to ensure the safe and effective use of
the prescribed drug or device. The oral consultation shall include
all subjects that pharmacists are required to discuss pursuant to
regulations adopted by the board pursuant to Section 4005.

end insert begin delete

(8)

end delete

begin insert ( end insert begin insert 9) end insert  A certified nurse-midwife who functions pursuant to a
standardized procedure or protocol described in Section 2746.51,
a nurse practitioner who functions pursuant to a standardized
procedure described in Section 2836.1, or protocol, a physician
assistant who functions pursuant to Section 3502.1, begin insert a registered
nurse who functions pursuant to Section 2725.1 end insert , or a naturopathic
doctor who functions pursuant to Section 3640.5, may hand to a
patient of the supervising physician and surgeon a properly labeled
prescription drug prepackaged by a physician and surgeon, a
manufacturer as defined in this chapter, or a pharmacist. begin insert Nothing
in this section shall preclude the use of an end insert begin insert automated end insert begin insert drug end insert begin insert delivery end insert
begin insert system described in Section 4186. end insert

(b) The Medical Board of California, the State Board of
Optometry, the Bureau of Naturopathic Medicine, the Dental Board
of California, the Osteopathic Medical Board of California, the
Board of Registered Nursing, the Veterinary Medical Board, and
the Physician Assistant Committee shall have authority with the
California State Board of Pharmacy to ensure compliance with
this section, and those boards are specifically charged with the
enforcement of this chapter with respect to their respective
licensees.

(c) “Prescriber,” as used in this section, means begin insert a person who is
licensed to prescribe and dispense dangerous drugs and devices,
including, but not limited to, end insert a begin delete person, end delete begin insert person end insert who holds a
physician’s and surgeon’s certificate, a license to practice
optometry, a license to practice naturopathic medicine, a license
to practice dentistry, a license to practice veterinary medicine, or
a certificate to practice podiatry, and who is duly registered by the
Medical Board of California, the State Board of Optometry, the
Bureau of Naturopathic Medicine, the Dental Board of California,
the Veterinary Medical Board, or the Board of Osteopathic
Examiners of this state.

begin insert

(d) This section shall not prevent a group practice, licensed
pursuant to Section 4180, from owning an inventory of dangerous
drugs and devices and dispensing the drugs and devices from the
inventory owned by the group practice provided that the following
conditions are met:

end insert begin insert

(1) Each prescriber dispenses dangerous drugs or devices only
to the patients seen or treated by that prescriber, and not to the
patient of any other prescriber in the group practice, and the drugs
or devices are packaged, labeled, and recorded in accordance
with paragraph (4) of subdivision (a).

end insert begin insert

(2) The group practice identifies a responsible prescriber within
the group practice who shall be named by the drug manufacturer
or wholesaler supplying the drugs as the recipient of the drugs on
all invoices, bills of lading, state or federal order forms, and other
documentation, and who shall be responsible for the
record-keeping and storage of the drug inventory.

end insert begin insert

(3) Records are maintained by each prescriber to identify the
identity of the patient and the name, strength, quantity, and
directions for use for each dangerous drug dispensed by the
prescriber to his or her patient.

end insert begin insert

(4) A daily dispensing log or some other paper or electronic
record is created each day, and maintained by the group practice,
to identify both of the following:

end insert begin insert

(A) A daily starting inventory of all dangerous drugs that are
jointly owned by the prescribers who comprise the group practice.

end insert begin insert

(B) The name, strength, and quantity of all dangerous drugs
dispensed by each prescriber.

end insert begin insert

(e) A prescriber employed by, or under contract to, a clinic or
group practice licensed under Section 4180 may dispense drugs
that are owned by the clinic or group practice.

end insert begin insert

(f) (1) For purposes of this section, a dangerous drug is owned
if it is delivered to the possession of a prescriber, clinic, or group
practice, and each prescriber, clinic, or group practice has
responsibility for the security and recordkeeping associated with
possession of the dangerous drugs, regardless of the person or
entity responsible for payment for the dangerous drug inventory.

end insert begin insert

(2) For the purposes of this section, “group practice” means
more than one prescriber practicing under a single professional
corporation or license, including a medical group or risk-bearing
organization as defined in the Knox-Keene Health Care Service
Plan Act of 1975 (Chapter 2.2 (commencing with Section 1340)
of Division 2 of the Health and Safety Code).

end insert

begin insert

begin insert SEC. end insert begin insert 2. end insert   

end insert

begin insert Section 4180 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

4180.  

(a) (1) Notwithstanding any provision of this chapter,
any of the following begin delete clinics end delete begin insert entities end insert may purchase drugs at
wholesale for administration or dispensing, under the direction of
a physician and surgeon, begin insert or other prescriber when permitted by
law, end insert to patients registered for care at the clinic:

(A) A licensed nonprofit community clinic or free clinic as
defined in paragraph (1) of subdivision (a) of Section 1204 of the
Health and Safety Code.

(B) A primary care clinic owned or operated by a county as
referred to in subdivision (b) of Section 1206 of the Health and
Safety Code.

(C) A clinic operated by a federally recognized Indian tribe or
tribal organization as referred to in subdivision (c) of Section 1206
of the Health and Safety Code.

(D) A clinic operated by a primary care community or free
clinic, operated on separate premises from a licensed clinic, and
that is open no more than 20 hours per week as referred to in
subdivision (h) of Section 1206 of the Health and Safety Code.

(E) A student health center clinic operated by a public institution
of higher education as referred to in subdivision (j) of Section 1206
of the Health and Safety Code.

(F) A nonprofit multispecialty clinic as referred to in subdivision
(l) of Section 1206 of the Health and Safety Code.

begin insert

(G) A group practice, as defined in Section 4170, that uses an
automated drug delivery system, as described in Section 4186.

end insert

(2) The clinic begin insert or group practice end insert 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.

(b) No clinic begin insert or group practice end insert shall be entitled to the benefits
of this section until it has obtained a license from the board. A
separate license shall be required for each clinic location. A clinic
begin insert or group practice end insert shall notify the board of any change in the
begin delete clinic’s end delete address begin insert of the clinic or group practice end insert on a form furnished
by the board.

begin insert

begin insert SEC. end insert begin insert 3. end insert   

end insert

begin insert Section 4186 of the end insert begin insert Business and Professions Code end insert begin insert is
amended to read: end insert

4186.  

(a)  begin delete Automated end delete begin insert An automated end insert drug delivery begin delete systems end delete
begin insert system end insert , as defined in subdivision begin delete (h) end delete begin insert (i) end insert , may be located in any
clinic begin insert or group practice end insert licensed by the board begin delete pursuant to end delete begin insert as
described in end insert Section 4180. begin delete If end delete

begin insert (b) end insert begin insert   end insert begin insert (1) end insert begin insert   end insert begin insert If end insert an automated drug delivery system is located in a
clinic, the clinic shall develop and implement written policies and
procedures to ensure safety, accuracy, accountability, security,
patient confidentiality, and maintenance of the quality, potency,
and purity of drugs. All policies and procedures shall be maintained
at the location where the automated drug system is being used.

begin insert

(2) If an automated drug delivery system is located in a group
practice, the group practice shall develop and implement written
policies and procedures to ensure safety, accuracy, accountability,
security, patient confidentiality, and maintenance of the quality,
potency, and purity of drugs. All prescribers who will be dispensing
drugs from the automated drug delivery system and all health care
professionals and delegated personnel authorized to stock, refill,
or retrieve the drugs inventory from the automated drug delivery
system shall be required to comply with the policies and procedures
developed by the group practice. All policies and procedures shall
be maintained at the location where the automated drug system is
being used.

end insert begin delete

(b)

end delete

begin insert ( end insert begin insert c) end insert  Drugs shall be removed from the automated drug delivery
system only upon authorization by a pharmacist begin insert or prescriber end insert after
the pharmacist begin insert or prescriber end insert has reviewed the prescription and the
patient’s profile for potential contraindications and adverse drug
reactions. Drugs removed from the automated drug delivery system
shall be provided to the patient by a health professional licensed
pursuant to this division begin insert or an individual operating under the
supervision of the prescriber end insert .

begin delete

(c)

end delete

begin insert ( end insert begin insert d) end insert  The stocking of an automated drug delivery system shall be
performed by a pharmacist begin insert or, in a clinic or group practice, by a
prescriber or a designee of the prescriber end insert .

begin delete

(d)

end delete

begin insert ( end insert begin insert e) end insert  Review of the drugs contained within, and the operation and
maintenance of, the automated drug delivery system shall be the
responsibility of the clinic begin insert in a clinic setting or by the responsible
prescriber in a group practice end insert . The review shall be conducted on
a monthly basis by a pharmacist begin insert or responsible prescriber end insert and
shall include a physical inspection of the drugs in the automated
drug delivery system, an inspection of the automated drug delivery
system machine for cleanliness, and a review of all transaction
records in order to verify the security and accountability of the
system.

begin delete

(e)

end delete

begin insert ( end insert begin insert f) end insert  The automated drug delivery system used at the clinic begin insert or
group practice end insert shall provide for patient consultation pursuant to
Section 1707.2 of Title 16 of the California Code of Regulations
with a pharmacist via a telecommunications link that has two-way
audio and video begin insert , unless a consultation is provided by the prescriber
pursuant to paragraph (8) of subdivision (a) of Section 4170 end insert .

begin delete

(f) The

end delete

begin insert (g) end insert begin insert   end insert begin insert A end insert pharmacist operating the automated drug delivery system
shall be begin delete located end delete begin insert licensed end insert in California.

begin delete

(g)

end delete

begin insert ( end insert begin insert h) end insert  Drugs dispensed from the automated drug delivery system
shall comply with the labeling requirements in Section 4076.

begin delete

(h)

end delete

begin insert ( end insert begin insert i) end insert  For purposes of this section, an “automated drug delivery
system” means a mechanical system controlled remotely by a
pharmacist begin insert , or, if used to facilitate prescriber dispensing by a
prescriber, end insert that performs operations or activities, other than
compounding or administration, relative to the storage, dispensing,
or distribution of prepackaged dangerous drugs or dangerous
devices. An automated drug delivery system shall collect, control,
and maintain all transaction information to accurately track the
movement of drugs into and out of the system for security,
accuracy, and begin delete accountability. end delete begin insert accountability and shall meet all of
the following requirements: end insert

begin insert

(1) The system shall be located within the clinic or office of the
group practice, and its contents shall be secure from access or
removal by unauthorized individuals.

end insert begin insert

(2) A policy and procedure manual shall be developed and
maintained and shall include the type or name of the system
including a serial number or other identifying nomenclature and
a description of the security provisions, stocking processes, and
other documentation practices of the clinic or group practice.

end insert begin insert

(3) The system shall have a method to ensure security of the
system to prevent unauthorized access to dangerous drugs or
devices contained within the system. The method may include the
use of electronic passwords, biometric identification, including
optic scanning or fingerprint, or other coded identification.

end insert begin insert

(4) The clinic or group practice shall employ a process of filling
and stocking the system with drugs. The stocking or restocking of
a drug shall only be completed by a pharmacist, prescriber, or
personnel designated by the pharmacist or prescriber and all of
the following shall apply:

end insert begin insert

(A) The cartridges or containers to be stocked or restocked shall
be provided by a licensed wholesale drug distributor or repackaged
by the pharmacy or prescriber in compliance with state and federal
law. The licensed wholesale drug distributor shall have a method
of receiving and disposing of rejected, expired, or unused
medications consistent with state or federal law.

end insert begin insert

(B) The individual cartridge or container shall be transported
to the dispensing site in a secure, tamper-evident package.

end insert begin insert

(C) The system shall use a bar code verification, electronic
verification, weight verification, radio frequency identification,
or similar process to ensure that the cartridge or container is
accurately stocked or restocked into the automated system. The
system shall provide for alerts to the responsible pharmacist or
prescriber if a cartridge or container is not recorded in the
automated system.

end insert begin insert

(D) The pharmacist or prescriber responsible for the dispensed
drug shall be responsible if the cartridge or container is stocked
or restocked incorrectly by the personnel designated to load the
cartridges or containers.

end insert begin insert

(5) The system shall maintain an electronic or hard copy record
of medication filled into the system, including the product
identification, lot number, and expiration date.

end insert begin insert

(6) The system shall maintain a readily retrievable electronic
record to identify all pharmacists, registered pharmacy technicians,
prescribers, and all other personnel involved in the dispensing of
a drug.

end insert begin insert

(7) The system shall be able to comply with product recalls
generated by any manufacturer or distributor and shall have a
process in place to isolate affected lot numbers.

end insert begin insert

(8) The record of transactions conducted through the automated
drug delivery system shall be available to authorized agents of the
board. The record of transactions shall, only to the extent
authorized or permitted by state or federal law, include the
following:

end insert begin insert

(A) Name of the patient.

end insert begin insert

(B) Name, strength, and dosage form of the drug product
dispensed.

end insert begin insert

(C) Quantity of drug dispensed.

end insert begin insert

(D) Date and time of dispensing.

end insert begin insert

(E) Prescription number or other unique serial number assigned
to the transaction.

end insert begin insert

(F) Name of prescriber.

end insert begin insert

(G) Identity of the pharmacist who approved the prescription,
or of the prescriber.

end insert begin insert

(H) Identity of the person to whom the drug was released.

end insert begin insert

(9) Unless the prescriber provides consultation pursuant to
regulations adopted by the board pursuant to Section 4005, the
system shall provide patients with telephonic access to consultation
by a California-licensed pharmacist.

end insert begin insert

(10) In the case of dangerous drugs that require reconstitution,
the prescriber or his or her designee shall reconstitute the
medication for the patient.

end insert begin insert

(j) The board is authorized to adopt regulations authorizing the
use of an automated drug delivery system that delivers dispensed
medications directly to a patient. The regulations shall be based,
in part, upon the board’s assessment of the safety of the systems.

end insert

begin insert

begin insert SEC. end insert begin insert 4. end insert   

end insert begin insert

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.

end insert

begin delete

SECTION 1.  

Section 1000 of the Business and Professions
Code is amended to read:

1000.  

The law governing practitioners of chiropractic is found
in an initiative act entitled “An act prescribing the terms upon
which licenses may be issued to practitioners of chiropractic,
creating the State Board of Chiropractic Examiners and declaring
its powers and duties, prescribing penalties for violation hereof,
and repealing all acts and parts of acts inconsistent herewith,”
adopted by the electors November 7, 1922. Notwithstanding any
other law, the powers and duties of the State Board of Chiropractic
Examiners, as set forth in this article and under the act creating
the board, shall be subject to review by the appropriate policy
committees of the Legislature. The review shall be performed as
if this chapter were scheduled to be repealed as of January 1, 2018.

SEC. 2.  

Section 2530.2 of the Business and Professions Code
is amended to read:

2530.2.  

As used in this chapter, unless the context otherwise
requires:

(a) “Board” means the Speech-Language Pathology and
Audiology and Hearing Aid Dispensers Board.

(b) “Person” means any individual, partnership, corporation,
limited liability company, or other organization or combination
thereof, except that only individuals can be licensed under this
chapter.

(c) A “speech-language pathologist” is a person who practices
speech-language pathology.

(d) The practice of speech-language pathology means all of the
following:

(1) The application of principles, methods, instrumental
procedures, and noninstrumental procedures for measurement,
testing, screening, evaluation, identification, prediction, and
counseling related to the development and disorders of speech,
voice, language, or swallowing.

(2) The application of principles and methods for preventing,
planning, directing, conducting, and supervising programs for
habilitating, rehabilitating, ameliorating, managing, or modifying
disorders of speech, voice, language, or swallowing in individuals
or groups of individuals.

(3) Conducting hearing screenings.

(4) Performing suctioning in connection with the scope of
practice described in paragraphs (1) and (2), after compliance with
a medical facility’s training protocols on suctioning procedures.

(e) (1) Instrumental procedures referred to in subdivision (d)
are the use of rigid and flexible endoscopes to observe the
pharyngeal and laryngeal areas of the throat in order to observe,
collect data, and measure the parameters of communication and
swallowing as well as to guide communication and swallowing
assessment and therapy.

(2) Nothing in this subdivision shall be construed as a diagnosis.
Any observation of an abnormality shall be referred to a physician
and surgeon.

(f) A licensed speech-language pathologist shall not perform a
flexible fiberoptic nasendoscopic procedure unless he or she has
received written verification from an otolaryngologist certified by
the American Board of Otolaryngology that the speech-language
pathologist has performed a minimum of 25 flexible fiberoptic
nasendoscopic procedures and is competent to perform these
procedures. The speech-language pathologist shall have this written
verification on file and readily available for inspection upon request
by the board. A speech-language pathologist shall pass a flexible
fiberoptic nasendoscopic instrument only under the direct
authorization of an otolaryngologist certified by the American
Board of Otolaryngology and the supervision of a physician and
surgeon.

(g) A licensed speech-language pathologist shall only perform
flexible endoscopic procedures described in subdivision (e) in a
setting that requires the facility to have protocols for emergency
medical backup procedures, including a physician and surgeon or
other appropriate medical professionals being readily available.

(h) “Speech-language pathology aide” means any person
meeting the minimum requirements established by the board, who
works directly under the supervision of a speech-language
pathologist.

(i) (1) “Speech-language pathology assistant” means a person
who meets the academic and supervised training requirements set
forth by the board and who is approved by the board to assist in
the provision of speech-language pathology under the direction
and supervision of a speech-language pathologist who shall be
responsible for the extent, kind, and quality of the services provided
by the speech-language pathology assistant.

(2) The supervising speech-language pathologist employed or
contracted for by a public school may hold a valid and current
license issued by the board, a valid, current, and professional clear
clinical or rehabilitative services credential in language, speech,
and hearing issued by the Commission on Teacher Credentialing,
or other credential authorizing service in language, speech, and
hearing issued by the Commission on Teacher Credentialing that
is not issued on the basis of an emergency permit or waiver of
requirements. For purposes of this paragraph, a “clear” credential
is a credential that is not issued pursuant to a waiver or emergency
permit and is as otherwise defined by the Commission on Teacher
Credentialing. Nothing in this section referring to credentialed
supervising speech-language pathologists expands existing
exemptions from licensing pursuant to Section 2530.5.

(j) An “audiologist” is one who practices audiology.

(k) “The practice of audiology” means the application of
principles, methods, and procedures of measurement, testing,
appraisal, prediction, consultation, counseling, instruction related
to auditory, vestibular, and related functions and the modification
of communicative disorders involving speech, language, auditory
behavior or other aberrant behavior resulting from auditory
dysfunction; and the planning, directing, conducting, supervising,
or participating in programs of identification of auditory disorders,
hearing conservation, cerumen removal, aural habilitation, and
rehabilitation, including, hearing aid recommendation and
evaluation procedures including, but not limited to, specifying
amplification requirements and evaluation of the results thereof,
auditory training, and speech reading, and the selling of hearing
aids.

(l) A “dispensing audiologist” is a person who is authorized to
sell hearing aids pursuant to his or her audiology license.

(m) “Audiology aide” means any person meeting the minimum
requirements established by the board. An audiology aid may not
perform any function that constitutes the practice of audiology
unless he or she is under the supervision of an audiologist. The
board may by regulation exempt certain functions performed by
an industrial audiology aide from supervision provided that his or
her employer has established a set of procedures or protocols that
the aide shall follow in performing these functions.

(n) “Medical board” means the Medical Board of California.

(o) A “hearing screening” performed by a speech-language
pathologist means a binary puretone screening at a preset intensity
level for the purpose of determining if the screened individuals
are in need of further medical or audiological evaluation.

(p) “Cerumen removal” means the nonroutine removal of
cerumen within the cartilaginous ear canal necessary for access in
performance of audiological procedures that shall occur under
physician and surgeon supervision. Cerumen removal, as provided
by this section, shall only be performed by a licensed audiologist.
Physician and surgeon supervision shall not be construed to require
the physical presence of the physician, but shall include all of the
following:

(1) Collaboration on the development of written standardized
protocols. The protocols shall include a requirement that the
supervised audiologist immediately refer to an appropriate
physician any trauma, including skin tears, bleeding, or other
pathology of the ear discovered in the process of cerumen removal
as defined in this subdivision.

(2) Approval by the supervising physician of the written
standardized protocol.

(3) The supervising physician shall be within the general
vicinity, as provided by the physician-audiologist protocol, of the
supervised audiologist and available by telephone contact at the
time of cerumen removal.

(4) A licensed physician and surgeon may not simultaneously
supervise more than two audiologists for purposes of cerumen
removal.

SEC. 3.  

Section 2531 of the Business and Professions Code is
amended to read:

2531.  

(a) There is in the Department of Consumer Affairs the
Speech-Language Pathology and Audiology and Hearing Aid
Dispensers Board in which the enforcement and administration of
this chapter are vested. The Speech-Language Pathology and
Audiology and Hearing Aid Dispensers Board shall consist of nine
members, three of whom shall be public members.

(b) This section shall remain in effect only until January 1, 2018,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2018, deletes or extends that date.
Notwithstanding any other law, the repeal of this section renders
the board subject to review by the appropriate policy committees
of the Legislature.

SEC. 4.  

Section 2531.75 of the Business and Professions Code
is amended to read:

2531.75.  

(a) The board may appoint a person exempt from
civil service who shall be designated as an executive officer and
who shall exercise the powers and perform the duties delegated
by the board and vested in him or her by this chapter.

(b) This section shall remain in effect only until January 1, 2018,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2018, deletes or extends that date.

SEC. 5.  

Section 2533 of the Business and Professions Code is
amended to read:

2533.  

The board may refuse to issue, or issue subject to terms
and conditions, a license on the grounds specified in Section 480,
or may suspend, revoke, or impose terms and conditions upon the
license of any licensee for any of the following:

(a) Conviction of a crime substantially related to the
qualifications, functions, and duties of a speech-language
pathologist or audiologist or hearing aid dispenser, as the case may
be. The record of the conviction shall be conclusive evidence
thereof.

(b) Securing a license by fraud or deceit.

(c) (1) The use or administering to himself or herself, of any
controlled substance; (2) the use of any of the dangerous drugs
specified in Section 4022, or of alcoholic beverages, to the extent,
or in a manner as to be dangerous or injurious to the licensee, to
any other person, or to the public, or to the extent that the use
impairs the ability of the licensee to practice speech-language
pathology or audiology safely; (3) more than one misdemeanor or
any felony involving the use, consumption, or self-administration
of any of the substances referred to in this section; or (4) any
combination of paragraph (1), (2), or (3). The record of the
conviction shall be conclusive evidence of unprofessional conduct.

(d) Advertising in violation of Section 17500. Advertising an
academic degree that was not validly awarded or earned under the
laws of this state or the applicable jurisdiction in which it was
issued is deemed to constitute a violation of Section 17500.

(e) Committing a dishonest or fraudulent act that is substantially
related to the qualifications, functions, or duties of a licensee.

(f) Incompetence, gross negligence, or repeated negligent acts.

(g) Other acts that have endangered or are likely to endanger
the health, welfare, and safety of the public.

(h) Use by a hearing aid dispenser of the term “doctor” or
“physician” or “clinic” or “audiologist,” or any derivation thereof,
except as authorized by law.

(i) The use, or causing the use, of any advertising or promotional
literature in a manner that has the capacity or tendency to mislead
or deceive purchasers or prospective purchasers.

(j) Any cause that would be grounds for denial of an application
for a license.

(k) Violation of Section 1689.6 or 1793.02 of the Civil Code.

(l) Violation of a term or condition of a probationary order of
a license issued by the board pursuant to Chapter 5 (commencing
with Section 11500) of Part 1 of Division 3 of Title 2 of the
Government Code.

SEC. 6.  

Section 2570.19 of the Business and Professions Code
is amended to read:

2570.19.  

(a) There is hereby created a California Board of
Occupational Therapy, hereafter referred to as the board. The board
shall enforce and administer this chapter.

(b) The members of the board shall consist of the following:

(1) Three occupational therapists who shall have practiced
occupational therapy for five years.

(2) One occupational therapy assistant who shall have assisted
in the practice of occupational therapy for five years.

(3) Three public members who shall not be licentiates of the
board, of any other board under this division, or of any board
referred to in Section 1000 or 3600.

(c) The Governor shall appoint the three occupational therapists
and one occupational therapy assistant to be members of the board.
The Governor, the Senate Committee on Rules, and the Speaker
of the Assembly shall each appoint a public member. Not more
than one member of the board shall be appointed from the full-time
faculty of any university, college, or other educational institution.

(d) All members shall be residents of California at the time of
their appointment. The occupational therapist and occupational
therapy assistant members shall have been engaged in rendering
occupational therapy services to the public, teaching, or research
in occupational therapy for at least five years preceding their
appointments.

(e) The public members may not be or have ever been
occupational therapists or occupational therapy assistants or in
training to become occupational therapists or occupational therapy
assistants. The public members may not be related to, or have a
household member who is, an occupational therapist or an
occupational therapy assistant, and may not have had, within two
years of the appointment, a substantial financial interest in a person
regulated by the board.

(f) The Governor shall appoint two board members for a term
of one year, two board members for a term of two years, and one
board member for a term of three years. Appointments made
thereafter shall be for four-year terms, but no person shall be
appointed to serve more than two consecutive terms. Terms shall
begin on the first day of the calendar year and end on the last day
of the calendar year or until successors are appointed, except for
the first appointed members who shall serve through the last
calendar day of the year in which they are appointed, before
commencing the terms prescribed by this section. Vacancies shall
be filled by appointment for the unexpired term. The board shall
annually elect one of its members as president.

(g) The board shall meet and hold at least one regular meeting
annually in the Cities of Sacramento, Los Angeles, and San
Francisco. The board may convene from time to time until its
business is concluded. Special meetings of the board may be held
at any time and place designated by the board.

(h) Notice of each meeting of the board shall be given in
accordance with the Bagley-Keene Open Meeting Act (Article 9
(commencing with Section 11120) of Chapter 1 of Part 1 of
Division 3 of Title 2 of the Government Code).

(i) Members of the board shall receive no compensation for
their services, but shall be entitled to reasonable travel and other
expenses incurred in the execution of their powers and duties in
accordance with Section 103.

(j) The appointing power shall have the power to remove any
member of the board from office for neglect of any duty imposed
by state law, for incompetency, or for unprofessional or
dishonorable conduct.

(k) This section shall remain in effect only until January 1, 2018,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2018, deletes or extends that date.
Notwithstanding any other law, the repeal of this section renders
the board subject to review by the appropriate policy committees
of the Legislature.

SEC. 7.  

Section 2602 of the Business and Professions Code is
amended to read:

2602.  

The Physical Therapy Board of California, hereafter
referred to as the board, shall enforce and administer this chapter.

This section shall remain in effect only until January 1, 2018,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2018, deletes or extends that date.

Notwithstanding any other provision of law, the repeal of this
section renders the board subject to review by the appropriate
policy committees of the Legislature.

SEC. 8.  

Section 2607.5 of the Business and Professions Code
is amended to read:

2607.5.  

(a) The board may appoint a person exempt from civil
service who shall be designated as an executive officer and who
shall exercise the powers and perform the duties delegated by the
board and vested in him or her by this chapter.

(b) This section shall remain in effect only until January 1, 2018,
and as of that date is repealed, unless a later enacted statute, that
is enacted before January 1, 2018, deletes or extends that date.

end delete