BILL NUMBER: SB 669 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY SEPTEMBER 3, 2013
AMENDED IN ASSEMBLY JULY 3, 2013
AMENDED IN SENATE MAY 28, 2013
AMENDED IN SENATE MAY 7, 2013
AMENDED IN SENATE APRIL 22, 2013
INTRODUCED BY Senator Huff
(Coauthors: Senators Gaines and Nielsen)
(Coauthors: Assembly Members Dahle and Maienschein)
FEBRUARY 22, 2013
An act to add Section 4119.3 to the Business and Professions Code,
to add Section 1714.23 to the Civil Code, and to add Section
1797.197a to the Health and Safety Code, relating to emergency
medical care.
LEGISLATIVE COUNSEL'S DIGEST
SB 669, as amended, Huff. Emergency medical care: epinephrine
auto-injectors.
(1) Existing law authorizes a school district or county office of
education to provide emergency epinephrine auto-injectors to trained
personnel, and authorizes that trained personnel to utilize those
epinephrine auto-injectors to provide emergency medical aid to
persons suffering from an anaphylactic reaction. The Pharmacy Law
authorizes a pharmacy to furnish epinephrine auto-injectors to a
school district or county office of education if certain conditions
are met. A violation of the Pharmacy Law is a crime.
Existing law requires the Emergency Medical Services Authority to
establish training and standards for all prehospital emergency
medical care personnel regarding the characteristics and method of
assessment and treatment of anaphylactic reactions and the use of
epinephrine, and to promulgate regulations therefor.
This bill would authorize a prehospital emergency medical care
person, first responder, person or lay
rescuer to use an epinephrine auto-injector to render emergency care
to another person, as specified. The bill would require the
California Emergency Medical Services (EMS) Authority to approve
authorized training providers and to establish and approve minimum
standards for training and the use and administration of epinephrine
auto-injectors. The bill would specify components to be included in
the minimum training and requirements. Under the bill, these
The bill would authorize the director of the
authority to deny, suspend, or revoke any approval or place any
approved training provider on probation upon a finding by the
director of an imminent threat to public health and safety, as
prescribed. The bill would create the Specialized First Aid Training
Program Approval Fund, and require the authority to assess a fee, to
be deposited into the fund, to cover the reasonable costs incurred by
the authority for the ongoing review and approval of training and
certification.
These provisions would 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
care, as specified. This The bill would
provide that nothing in these provisions shall be construed to limit
or restrict the ability of prehospital emergency medical care
personnel to administer epinephrine, including the use of epinephrine
auto-injectors, or to require additional training or certification,
if the administration of epinephrine is part of their scope of
practice.
The bill would authorize a pharmacy to dispense epinephrine
auto-injectors to a prehospital emergency medical care
person, first responder, person or lay rescuer
for the purpose of rendering emergency care in accordance with these
provisions. Because a violation of this requirement would be a crime,
the bill would impose a state-mandated local program. The bill
would require epinephrine auto-injectors obtained by prehospital
emergency medical care personnel to be used only when functioning
outside the course of the person's occupational duties, or as a
volunteer, 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.
This bill would provide that a prehospital emergency medical care
person, first responder, person or lay
rescuer 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 specified certification and training
requirements and standards, except as specified. The bill
also would provide immunity to a local agency, entity of state or
local government, or other public or private organization that
sponsors, authorizes, supports, finances, or supervises the training
of those persons, or develops standards, for civil damages alleged to
result from those training programs or standards, 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 4119.3 is added to the Business and Professions
Code, to read:
4119.3. (a) Notwithstanding any other law, a pharmacy may
dispense epinephrine auto-injectors to a prehospital emergency
medical care person, first responder, person
or lay rescuer 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) A physician and surgeon provides a written order that
specifies the quantity of epinephrine auto-injectors to be dispensed
to a person described in subdivision (b) of Section 1797.197a of the
Health and Safety Code. The physician and surgeon may issue the
prescription only upon presentation of a current certificate
demonstrating that the person is trained and qualified under Section
1797.197a of the Health and Safety Code to administer an epinephrine
auto-injector to another person in an emergency situation. The
prescription shall specify that the dispensed epinephrine
auto-injector is for "EMS "First Aid
Purposes Only" and that the named recipient is a "Section 1797.197a
Responder." A new prescription shall be written for any additional
epinephrine auto-injectors required.
(2) (A) The pharmacy shall label each epinephrine auto-injector
dispensed with all of the following:
(i) The name of the person to whom the prescription was issued.
(ii) The designations "Section 1797.197a Responder" and
"EMS "First Aid Purposes Only."
(iii) The dosage, use, and expiration date.
(B) Each dispensed prescription shall include the manufacturer's
product information sheet for the epinephrine auto-injector.
(b) The person described in subdivision (b) of Section 1797.197a
of the Health and Safety Code receiving epinephrine auto-injectors
pursuant to this section shall make and maintain a record for five
years reflecting dates of receipt, use, and destruction of each
auto-injector dispensed, the name of any person to whom epinephrine
was administered using an auto-injector, and the circumstances and
manner of destruction of any auto-injectors.
(c) The epinephrine auto-injectors 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 is added to the Civil Code, 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) 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.
(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) (1) In order to encourage training of persons described in
subdivision (b) of Section 1797.197a of the Health and Safety Code in
the emergency administration of epinephrine auto-injectors, and to
encourage that emergency care, a local agency, entity of state or
local government, or other public or private organization that
sponsors, authorizes, supports, finances, or supervises the training
of those persons, or develops standards in accordance with Section
1797.197a of the Health and Safety Code, including, but not limited
to, the California Emergency Medical Services (EMS) Authority, the
local emergency medical system agency, the county department of
health, the State Department of Public Health, the American Academy
of Allergy, Asthma & Immunology, the American Academy of Pediatrics,
the American Heart Association, the American Red Cross, and the
California Medical Association, shall not be liable for civil damages
alleged to result from those training programs or standards.
(2) The protection specified in paragraph (1) shall not apply when
it is alleged that the personal injury or wrongful death was
proximately caused by an authorized training provider's failure to
meet the minimal statutory training requirements and standards
established pursuant to subdivision (c) of Section 1797.197a of the
Health and Safety Code, or it is alleged that the authorized training
provider otherwise demonstrated gross negligence in the training or
certification of an individual whose subsequent actions caused
personal injury or wrongful death in the rendering of emergency care
treatment by the use of an epinephrine auto-injector.
(e)
( 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 is added to the Health and Safety Code,
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) "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.
(3) "First responder" means a police officer, firefighter, rescue
worker, or any other person who provides emergency response, first
aid care, or other medically related assistance either in the course
of the person's occupational duties or as a volunteer.
(4)
( 3) "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)
( 4) "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, first
responder, or a 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. 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 pursuant to this section to
administer an epinephrine auto-injector as a prehospital emergency
medical care person, first responder, person
or lay rescuer 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 address the
conditions described in subparagraph (A) of paragraph (1) of
subdivision (a) 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 California Emergency Medical
Services (EMS) Authority. The authority may designate existing
training standards for the use and administration of epinephrine
auto-injectors by first responders and 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 911 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 EMS 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 of the authority 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).
(d)
(e) 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.
(e)
(f) 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.