BILL NUMBER: AB 1386 AMENDED
BILL TEXT
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, 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.
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 pursuant to those provisions. 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 State Department of Public Health
on incidents related to the administration of epinephrine
auto-injectors. The bill would also require the department to issue
an annual report summarizing and analyzing the reports submitted to
the department pursuant to the bill's provisions.
(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 employees, agents,
any employee, agent, or other trained
individuals individual of an authorized entity
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. The bill would also provide that an authorized entity
located in this state shall not be liable, in this state,
for any injuries or related damages that result from the provision or
administration of an epinephrine auto-injector by its employees or
agents outside of this state if the entity or its employee or agent
would not have been liable for those injuries or related damages had
the provision or administration occurred within this state.
is not liable for any civil damages resulting from any act or
omission connected to the administration of an epinephrine
auto-injector, 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, if both of the
following requirements are met:
(1) The epinephrine auto-injectors are furnished exclusively for
use at or in connection with an authorized entity.
the possession of an authorized entity and for use by its
employees, volunteers, and agents, first responder, or by a family
member or caregiver of the person who appears to be experiencing
anaphylaxis, as defined by paragraph (1) of subdivision
(a) of Section 1714.23 of the Civil Code, or by the person who
appears to be experiencing anaphylaxis, as defined by paragraph (1)
of subdivision (a) of Section 1714.23 of the Civil Code.
(2) An authorized health care provider provides a prescription
that specifies the quantity of epinephrine auto-injectors to be
furnished.
(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.
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 drug delivery
system with a spring-activated concealed needle that is designed for
emergency administration of epinephrine to provide rapid, convenient
first aid for persons suffering from anaphylaxis.
(b) (1) Any person described in subdivision (b) of Section
1797.197a of the Health and Safety Code or employees,
agents, or other trained individuals of an authorized entity, as
defined by paragraph (2) of subdivision (a) 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) An authorized health care provider that prescribes or
dispenses an epinephrine auto-injector or a pharmacist that
dispenses an epinephrine auto-injector to a person
described in subdivision (b) of Section 1797.197a of the Health and
Safety Code or an authorized entity is not liable for any civil
damages resulting from any act or omission related to the provision
of an epinephrine auto-injector.
(3) A person that conducts the training described in subdivision
(c) of Section 1797.197a of the Health and Safety Code is not liable
for any civil damages resulting from any act or omission
related to the acquisition, possession, administration, or provision
of an of the lay rescuer, as defined by paragraph (4)
of subdivision (a) of Section 1797.197a of the Health and Safety
Code, who renders emergency care by administering the
epinephrine auto-injector.
(4) (A) An authorized entity
located in this state shall not be liable, in this
state, for any injuries or related damages that result from the
provision or 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 its
employees or agents outside of this state if the entity or its
employee or agent would not have been liable for those injuries or
related damages had the provision or administration occurred within
this state. 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,
or who, in good faith, and not for compensation, renders emergency
medical or nonmedical care at the scene of an emergency.
(5) An authorized entity that possesses and makes available
epinephrine auto-injectors, including third parties that facilitate
the availability of epinephrine auto-injectors to an authorized
entity, is not liable for any injuries or related damages that result
from any act or omission taken pursuant to this section.
(B) The failure of an authorized entity to possess or administer
an epinephrine auto-injector shall not result in civil liability.
(6)
(5) This subdivision does not eliminate,
limit, or reduce affect any other immunity or
defense that may otherwise be is
available under state law. law, including,
but not limited to, the immunity from liability for any civil damages
resulting from any act or omission other than an act or omission
constituting gross negligence or willful or wanton misconduct of a
person who in good faith, and not for compensation, renders emergency
medical or nonmedical care at the scene of an emergency as provided
by section 1799.102 of the Health and Safety Code.
(c) The protection specified in 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.
SEC. 3. 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 in connection with,
or at which, allergens capable of causing anaphylaxis may be present,
including, but not limited to, recreation camps, colleges and
universities, day care facilities, youth sports leagues, amusement
parks, restaurants, places of employment, and sports arenas.
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 drug delivery
system with a spring-activated concealed needle that is designed for
emergency administration of epinephrine to provide rapid, convenient
first aid for persons suffering from anaphylaxis.
(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, lay
rescuer, or employees, agents, or other trained individuals of an
authorized entity 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). An authorized health care provider may
issue a prescription for an epinephrine auto-injector to a person
described in this subdivision for the purpose of rendering emergency
care to another person, upon presentation of current certification
demonstrating that person is trained and qualified to administer an
epinephrine auto-injector as a prehospital emergency medical care
person or lay rescuer, pursuant to this section or any other statute
or regulation.
(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) An authorized health care provider may prescribe epinephrine
auto-injectors to an authorized entity or to an employee or
agent of an authorized entity who holds a valid certification
demonstrating that the person is trained and qualified to administer
an epinephrine auto-injector as a lay rescuer. entity.
Epinephrine auto-injectors acquired by an authorized entity
shall be stored in a location readily accessible in an emergency and
in accordance with the epinephrine auto-injectors instructions for
use and any additional requirements that may be established by the
authority.
(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.
(2) Submit to the State Department of Public Health, on a form
developed by the State Department of Public Health, a report of each
incident on the authorized entity's premises that involves the
administration of an epinephrine auto-injector. The State Department
of Public Health shall annually publish a report that summarizes and
analyzes 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. 4. 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.