BILL NUMBER: AB 1386 AMENDED
BILL TEXT
AMENDED IN SENATE JUNE 28, 2016
AMENDED IN SENATE JUNE 13, 2016
AMENDED IN SENATE MAY 31, 2016
AMENDED IN ASSEMBLY JANUARY 13, 2016
AMENDED IN ASSEMBLY JANUARY 5, 2016
AMENDED IN ASSEMBLY JANUARY 4, 2016
AMENDED IN ASSEMBLY APRIL 16, 2015
AMENDED IN ASSEMBLY MARCH 26, 2015
INTRODUCED BY Assembly Member Low
FEBRUARY 27, 2015
An act to add Section 4119.4 to the Business and Professions Code,
to amend Section 1714.23 of the Civil Code, to amend Section 49414
of the Education Code, and to amend Section 1797.197a of the Health
and Safety Code, relating to emergency medical care.
LEGISLATIVE COUNSEL'S DIGEST
AB 1386, as amended, Low. Emergency medical care: epinephrine
auto-injectors.
(1) Existing law authorizes a prehospital emergency medical care
person, first responder, or lay rescuer to use an epinephrine
auto-injector to render emergency care to another person, as
specified. Existing law requires the Emergency Medical Services
Authority to approve authorized training providers and the minimum
standards for training and the use and administration of epinephrine
auto-injectors. The existing Pharmacy Law also authorizes a pharmacy
to dispense epinephrine auto-injectors to a prehospital emergency
medical care person, first responder, or lay rescuer for the purpose
of rendering emergency care in accordance with these provisions. A
violation of the Pharmacy Law is a crime. Existing law requires
school districts, county offices of education, and charter schools to
provide emergency epinephrine auto-injectors, as defined, to school
nurses and trained personnel who have volunteered to use epinephrine
auto-injectors under emergency circumstances, as specified, and
authorizes school nurses and trained personnel to use epinephrine
auto-injectors to provide emergency medical aid to persons suffering,
or reasonably believed to be suffering, from an anaphylactic
reaction.
This bill would permit an "authorized entity," as defined, to use
an epinephrine auto-injector to render emergency care to another
person in accordance with these provisions. The bill would also
authorize a pharmacy to furnish epinephrine auto-injectors to an
authorized entity, as provided. Because a violation of these
provisions would be a crime, the bill would impose a state-mandated
local program. The bill would require an authorized entity to create
and maintain a specified operations plan relating to its use of
epinephrine auto-injectors, and would require those entities to
submit a report to the Emergency Medical Services Authority of each
incident that involves the administration of an epinephrine
auto-injector, not more than 30 days after each use. The bill would
also require the authority to publish an annual report summarizing
the reports submitted to the authority pursuant to the bill's
provisions. The bill would define the term "epinephrine auto-injector"
for purposes of these provisions and other related provisions that
authorize the use of epinephrine auto-injectors, as specified.
(2) Under existing law, everyone is generally responsible, not
only for the result of his or her willful acts, but also for an
injury occasioned to another by his or her want of ordinary care or
skill in the management of his or her property or person, except so
far as the latter has, willfully or by want of ordinary care, brought
the injury upon himself or herself. Existing law also provides that
a prehospital emergency care person, first responder, or lay rescuer
who administers an epinephrine auto-injector to another person who
appears to be experiencing anaphylaxis at the scene of an emergency
situation, in good faith and not for compensation, is not liable for
any civil damages resulting from his or her acts or omissions in
administering the epinephrine auto-injector, if that person has
complied with specified certification and training requirements and
standards.
This bill would provide that an authorized entity is not liable
for any civil damages resulting from any act or omission connected to
the administration of an epinephrine auto-injector, as specified.
The bill would also exempt an authorizing physician and surgeon from
certain sanctions for the issuance of an epinephrine auto-injector
under those provisions, except as specified.
(3)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 4119.4 is added to the Business and Professions
Code, to read:
4119.4. (a) Notwithstanding any other law, a pharmacy may furnish
epinephrine auto-injectors to an authorized entity, as
defined by Section 1797.197a of the Health and Safety Code,
for the purpose of rendering emergency care in accordance with
Section 1797.197a of the Health and Safety Code, if both of the
following requirements are met:
(1) The epinephrine auto-injectors are furnished exclusively for
use by, or in connection with, an authorized entity.
(2) An authorized health care provider provides a prescription
that specifies the quantity of epinephrine auto-injectors to be
furnished. furnished to an authorized entity
described in subdivision (a) of Section 1797.197a of the Health and
Safety Code. A new prescription shall be written for any additional
epinephrine auto-injectors required for use.
(b) The pharmacy shall label each epinephrine auto-injector
dispensed with all of the following:
(1) The name of the person or entity to whom the prescription was
issued.
(2) The designations "Section 1797.197a Responder" and "First Aid
Purposes Only."
(3) The dosage, use, and expiration date.
(c) Each dispensed prescription shall include the manufacturer's
product information sheet for the epinephrine auto-injector.
(d) Records regarding the acquisition and disposition of
epinephrine auto-injectors furnished pursuant to subdivision (a)
shall be maintained by the authorized entity for a period of three
years from the date the records were created. The authorized entity
shall be responsible for monitoring the supply of epinephrine
auto-injectors and ensuring the destruction of expired epinephrine
auto-injectors.
(e) The epinephrine auto-injector dispensed pursuant to this
section may be used only for the purpose, and under the
circumstances, described in Section 1797.197a of the Health and
Safety Code.
(f) For purposes of this section, "epinephrine auto-injector"
means a disposable delivery device designed for the automatic
injection of a premeasured dose of epinephrine into the human body to
prevent or treat a life-threatening allergic reaction.
SEC. 2. Section 1714.23 of the Civil Code is amended to read:
1714.23. (a) For purposes of this section, the following
definitions shall apply:
(1) "Anaphylaxis" means a potentially life-threatening
hypersensitivity or allergic reaction to a substance.
(A) Symptoms of anaphylaxis may include shortness of breath,
wheezing, difficulty breathing, difficulty talking or swallowing,
hives, itching, swelling, shock, or asthma.
(B) Causes of anaphylaxis may include, but are not limited to,
insect stings or bites, foods, drugs, and other allergens, as well as
idiopathic or exercise-induced anaphylaxis.
(2) "Epinephrine auto-injector" means a disposable delivery device
designed for the automatic injection of a premeasured dose of
epinephrine into the human body to prevent or treat a
life-threatening allergic reaction.
(b) (1) Any person described in subdivision (b) of Section
1797.197a of the Health and Safety Code who administers an
epinephrine auto-injector, in good faith and not for compensation, to
another person who appears to be experiencing anaphylaxis at the
scene of an emergency situation is not liable for any civil damages
resulting from his or her acts or omissions in administering the
epinephrine auto-injector, if that person has complied with the
requirements and standards of Section 1797.197a of the Health and
Safety Code.
(2) (A) An authorized entity shall not be liable for any civil
damages resulting from any act or omission other than an act or
omission constituting gross negligence or willful or wanton
misconduct connected to the administration of an epinephrine
auto-injector by any one of its employees, volunteers, or agents who
is a lay rescuer, as defined by paragraph (4) of subdivision (a) of
Section 1797.197a of the Health and Safety Code.
Code, if the entity has complied with all applicable
requirements of Section 1797.197a of the Health and Safety Code.
(B) The failure of an authorized entity to possess or administer
an epinephrine auto-injector shall not result in civil liability.
(3) This subdivision does not affect any other immunity or defense
that is available under law.
(c) The protection specified in paragraph (1) of
subdivision (b) shall not apply in a case of personal injury or
wrongful death that results from the gross negligence or willful or
wanton misconduct of the person who renders emergency care treatment
by the use of an epinephrine auto-injector.
(d) Nothing in this section relieves a manufacturer, designer,
developer, distributor, or supplier of an epinephrine auto-injector
of liability under any other applicable law.
(e) An authorizing physician and surgeon is not subject to
professional review, liable in a civil action, or subject to criminal
prosecution for the issuance of a prescription or order
pursuant to this section, in accordance with Section
1797.197a of the Health and Safety Code unless the physician
and surgeon's issuance of the prescription or order constitutes gross
negligence or willful or malicious conduct.
SEC. 3. Section 49414 of the Education Code is amended to read:
49414. (a) School districts, county offices of education, and
charter schools shall provide emergency epinephrine auto-injectors to
school nurses or trained personnel who have volunteered pursuant to
subdivision (d), and school nurses or trained personnel may use
epinephrine auto-injectors to provide emergency medical aid to
persons suffering, or reasonably believed to be suffering, from an
anaphylactic reaction.
(b) For purposes of this section, the following terms have the
following meanings:
(1) "Anaphylaxis" means a potentially life-threatening
hypersensitivity to a substance.
(A) Symptoms of anaphylaxis may include shortness of breath,
wheezing, difficulty breathing, difficulty talking or swallowing,
hives, itching, swelling, shock, or asthma.
(B) Causes of anaphylaxis may include, but are not limited to, an
insect sting, food allergy, drug reaction, and exercise.
(2) "Authorizing physician and surgeon" may include, but is not
limited to, a physician and surgeon employed by, or contracting with,
a local educational agency, a medical director of the local health
department, or a local emergency medical services director.
(3) "Epinephrine auto-injector" means a disposable delivery device
designed for the automatic injection of a premeasured dose of
epinephrine into the human body to prevent or treat a
life-threatening allergic reaction.
(4) "Qualified supervisor of health" may include, but is not
limited to, a school nurse.
(5) "Volunteer" or "trained personnel" means an employee who has
volunteered to administer epinephrine auto-injectors to a person if
the person is suffering, or reasonably believed to be suffering, from
anaphylaxis, has been designated by a school, and has received
training pursuant to subdivision (d).
(c) Each private elementary and secondary school in the state may
voluntarily determine whether or not to make emergency epinephrine
auto-injectors and trained personnel available at its school. In
making this determination, a school shall evaluate the emergency
medical response time to the school and determine whether initiating
emergency medical services is an acceptable alternative to
epinephrine auto-injectors and trained personnel. A private
elementary or secondary school choosing to exercise the authority
provided under this subdivision shall not receive state funds
specifically for purposes of this subdivision.
(d) Each public and private elementary and secondary school in the
state may designate one or more volunteers to receive initial and
annual refresher training, based on the standards developed pursuant
to subdivision (e), regarding the storage and emergency use of an
epinephrine auto-injector from the school nurse or other qualified
person designated by an authorizing physician and surgeon.
(e) (1) Every five years, or sooner as deemed necessary by the
Superintendent, the Superintendent shall review minimum standards of
training for the administration of epinephrine auto-injectors that
satisfy the requirements of paragraph (2). For purposes of this
subdivision, the Superintendent shall consult with organizations and
providers with expertise in administering epinephrine auto-injectors
and administering medication in a school environment, including, but
not limited to, the State Department of Public Health, the Emergency
Medical Services Authority, the American Academy of Allergy, Asthma
and Immunology, the California School Nurses Organization, the
California Medical Association, the American Academy of Pediatrics,
Food Allergy Research and Education, the California Society of
Allergy, Asthma and Immunology, the American College of Allergy,
Asthma and Immunology, the Sean N. Parker Center for Allergy
Research, and others.
(2) Training established pursuant to this subdivision shall
include all of the following:
(A) Techniques for recognizing symptoms of anaphylaxis.
(B) Standards and procedures for the storage, restocking, and
emergency use of epinephrine auto-injectors.
(C) Emergency followup procedures, including calling the emergency
911 telephone number and contacting, if possible, the pupil's parent
and physician.
(D) Recommendations on the necessity of instruction and
certification in cardiopulmonary resuscitation.
(E) Instruction on how to determine whether to use an adult
epinephrine auto-injector or a junior epinephrine auto-injector,
which shall include consideration of a pupil's grade level or age as
a guideline of equivalency for the appropriate pupil weight
determination.
(F) Written materials covering the information required under this
subdivision.
(3) Training established pursuant to this subdivision shall be
consistent with the most recent Voluntary Guidelines for Managing
Food Allergies In Schools and Early Care and Education Programs
published by the federal Centers for Disease Control and Prevention
and the most recent guidelines for medication administration issued
by the department.
(4) A school shall retain for reference the written materials
prepared under subparagraph (F) of paragraph (2).
(f) A school district, county office of education, or charter
school shall distribute a notice at least once per school year to all
staff that contains the following information:
(1) A description of the volunteer request stating that the
request is for volunteers to be trained to administer an epinephrine
auto-injector to a person if the person is suffering, or reasonably
believed to be suffering, from anaphylaxis, as specified in
subdivision (b).
(2) A description of the training that the volunteer will receive
pursuant to subdivision (d).
(g) (1) A qualified supervisor of health at a school district,
county office of education, or charter school shall obtain from an
authorizing physician and surgeon a prescription for each school for
epinephrine auto-injectors that, at a minimum, includes, for
elementary schools, one regular epinephrine auto-injector and one
junior epinephrine auto-injector, and for junior high schools, middle
schools, and high schools, if there are no pupils who require a
junior epinephrine auto-injector, one regular epinephrine
auto-injector. A qualified supervisor of health at a school district,
county office of education, or charter school shall be responsible
for stocking the epinephrine auto-injector and restocking it if it is
used.
(2) If a school district, county office of education, or charter
school does not have a qualified supervisor of health, an
administrator at the school district, county office of education, or
charter school shall carry out the duties specified in paragraph (1).
(3) A prescription pursuant to this subdivision may be filled by
local or mail order pharmacies or epinephrine auto-injector
manufacturers.
(4) An authorizing physician and surgeon shall not be subject to
professional review, be liable in a civil action, or be subject to
criminal prosecution for the issuance of a prescription or order
pursuant to this section, unless the physician and surgeon's issuance
of the prescription or order constitutes gross negligence or willful
or malicious conduct.
(h) A school nurse or, if the school does not have a school nurse
or the school nurse is not onsite or available, a volunteer may
administer an epinephrine auto-injector to a person exhibiting
potentially life-threatening symptoms of anaphylaxis at school or a
school activity when a physician is not immediately available. If the
epinephrine auto-injector is used it shall be restocked as soon as
reasonably possible, but no later than two weeks after it is used.
Epinephrine auto-injectors shall be restocked before their expiration
date.
(i) A volunteer shall initiate emergency medical services or other
appropriate medical followup in accordance with the training
materials retained pursuant to paragraph (4) of subdivision (e).
(j) A school district, county office of education, or charter
school shall ensure that each employee who volunteers under this
section will be provided defense and indemnification by the school
district, county office of education, or charter school for any and
all civil liability, in accordance with, but not limited to, that
provided in Division 3.6 (commencing with Section 810) of Title 1 of
the Government Code. This information shall be reduced to writing,
provided to the volunteer, and retained in the volunteer's personnel
file.
(k) A state agency, the department, or a public school may accept
gifts, grants, and donations from any source for the support of the
public school carrying out the provisions of this section, including,
but not limited to, the acceptance of epinephrine auto-injectors
from a manufacturer or wholesaler.
SEC. 4. Section 1797.197a of the Health and Safety Code is amended
to read:
1797.197a. (a) For purposes of this section, the following
definitions shall apply:
(1) "Anaphylaxis" means a potentially life-threatening
hypersensitivity or allergic reaction to a substance.
(A) Symptoms of anaphylaxis may include shortness of breath,
wheezing, difficulty breathing, difficulty talking or swallowing,
hives, itching, swelling, shock, or asthma.
(B) Causes of anaphylaxis may include, but are not limited to,
insect stings or bites, foods, drugs, and other allergens, as well as
idiopathic or exercise-induced anaphylaxis.
(2) "Authorized entity" means any for-profit, nonprofit, or
government entity or organization that employs at least one person or
utilizes at least one volunteer or agent that has voluntarily
completed a training course as described in subdivision (c).
(3) "Epinephrine auto-injector" means a disposable delivery device
designed for the automatic injection of a premeasured dose of
epinephrine into the human body to prevent or treat a
life-threatening allergic reaction.
(4) "Lay rescuer" means any person who has met the training
standards and other requirements of this section but who is not
otherwise licensed or certified to use an epinephrine auto-injector
on another person.
(5) "Prehospital emergency medical care person" has the same
meaning as defined in paragraph (2) of subdivision (a) of Section
1797.189.
(b) A prehospital emergency medical care person or lay rescuer may
use an epinephrine auto-injector to render emergency care to another
person if all of the following requirements are met:
(1) The epinephrine auto-injector is legally obtained by
prescription from an authorized health care provider or from an
authorized entity that acquired the epinephrine auto-injector
pursuant to subdivision (e).
(2) The epinephrine auto-injector is used on another, with the
expressed or implied consent of that person, to treat anaphylaxis.
(3) The epinephrine auto-injector is stored and maintained as
directed by the manufacturer's instructions for that product.
(4) The person using the epinephrine auto-injector has
successfully completed a course of training with an authorized
training provider, as described in subdivision (c), and has current
certification of training issued by the provider.
(5) The epinephrine auto-injectors obtained by prehospital
emergency medical care personnel pursuant to Section 4119.3 of the
Business and Professions Code shall be used only when functioning
outside the course of the person's occupational duties, or as a
volunteer, pursuant to this section.
(6) The Emergency Medical Services System is activated as soon as
practicable when an epinephrine auto-injector is used.
(c) (1) The authorized training providers shall be approved, and
the minimum standards for training and the use and administration of
epinephrine auto-injectors pursuant to this section shall be
established and approved, by the authority. The authority may
designate existing training standards for the use and administration
of epinephrine auto-injectors by prehospital emergency medical care
personnel to satisfy the requirements of this section.
(2) The minimum training and requirements shall include all of the
following components:
(A) Techniques for recognizing circumstances, signs, and symptoms
of anaphylaxis.
(B) Standards and procedures for proper storage and emergency use
of epinephrine auto-injectors.
(C) Emergency followup procedures, including activation of the
Emergency Medical Services System, by calling the emergency 9-1-1
telephone number or otherwise alerting and summoning more advanced
medical personnel and services.
(D) Compliance with all regulations governing the training,
indications, use, and precautions concerning epinephrine
auto-injectors.
(E) Written material covering the information required under this
provision, including the manufacturer product information sheets on
commonly available models of epinephrine auto-injectors.
(F) Completion of a training course in cardiopulmonary
resuscitation and the use of an automatic external defibrillator
(AED) for infants, children, and adults that complies with
regulations adopted by the authority and the standards of the
American Heart Association or the American Red Cross, and a current
certification for that training.
(3) Training certification shall be valid for no more than two
years, after which recertification with an authorized training
provider is required.
(4) The director may, in accordance with regulations adopted by
the authority, deny, suspend, or revoke any approval issued under
this subdivision or may place any approved training provider on
probation upon a finding by the director of an imminent threat to
public health and safety, as evidenced by any of the following:
(A) Fraud.
(B) Incompetence.
(C) The commission of any fraudulent, dishonest, or corrupt act
that is substantially related to the qualifications, functions, or
duties of training program directors or instructors.
(D) Conviction of any crime that is substantially related to the
qualifications, functions, or duties of training program directors or
instructors. The record of conviction or a certified copy of the
record shall be conclusive evidence of the conviction.
(E) Violating or attempting to violate, directly or indirectly, or
assisting in or abetting the violation of, or conspiring to violate,
any provision of this section or the regulations promulgated by the
authority pertaining to the review and approval of training programs
in anaphylaxis and the use and administration of epinephrine
auto-injectors, as described in this subdivision.
(d) (1) The authority shall assess a fee pursuant to regulation
sufficient to cover the reasonable costs incurred by the authority
for the ongoing review and approval of training and certification
under subdivision (c).
(2) The fees shall be deposited in the Specialized First Aid
Training Program Approval Fund, which is hereby created in the State
Treasury. All moneys deposited in the fund shall be made available,
upon appropriation, to the authority for purposes described in
paragraph (1).
(3) The authority may transfer unused portions of the Specialized
First Aid Training Program Approval Fund to the Surplus Money
Investment Fund. Funds transferred to the Surplus Money Investment
Fund shall be placed in a separate trust account, and shall be
available for transfer to the Specialized First Aid Training Program
Approval Fund, together with the interest earned, when requested by
the authority.
(4) The authority shall maintain a reserve balance in the
Specialized First Aid Training Program Approval Fund of 5 percent of
annual revenues. Any increase in the fees deposited in the
Specialized First Aid Training Program Approval Fund shall be
effective upon determination by the authority that additional moneys
are required to fund expenditures pursuant to subdivision (c).
(e) (1) An authorized health care provider may issue a
prescription for an epinephrine auto-injector to a prehospital
emergency medical care person or a lay rescuer for the purpose of
rendering emergency care to another person upon presentation of a
current epinephrine auto-injector certification card issued by the
authority demonstrating that the person is trained and qualified to
administer an epinephrine auto-injector pursuant to this section or
any other law.
(2) An authorized health care provider may issue a prescription
for an epinephrine auto-injector to an authorized entity if the
authorized entity submits evidence it employs at least one person, or
utilizes at least one volunteer or agent, who is trained and has a
current epinephrine auto-injector certification card issued by the
authority demonstrating that the person is qualified to administer an
epinephrine auto-injector pursuant to this section.
(f) An authorized entity that possesses and makes available
epinephrine auto-injectors shall do both of the following:
(1) Create and maintain on its premises an operations plan that
includes all of the following:
(A) The name and contact number for the authorized health care
provider who prescribed the epinephrine auto-injector.
(B) Where and how the epinephrine auto-injector will be stored.
(C) The names of the designated employees or agents who have
completed the training program required by this section and who are
authorized to administer the epinephrine auto-injector.
(D) How and when the epinephrine auto-injector will be inspected
for an expiration date.
(E) The process to replace the expired epinephrine auto-injector,
including the proper disposal of the expired epinephrine
auto-injector or used epinephrine auto-injector in a sharps
container.
(2) Submit to the authority, in a manner identified by the
authority, a report of each incident that involves the use of an
epinephrine auto-injector, not more than 30 days after each use. The
authority shall annually publish a report that summarizes all reports
submitted to it under this subdivision.
(g) This section shall not apply to a school district or county
office of education, or its personnel, that provides and utilizes
epinephrine auto-injectors to provide emergency medical aid pursuant
to Section 49414 of the Education Code.
(h) This section shall not be construed to limit or restrict the
ability of prehospital emergency medical care personnel, under any
other statute or regulation, to administer epinephrine, including the
use of epinephrine auto-injectors, or to require additional training
or certification beyond what is already required under the other
statute or regulation.
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.