BILL ANALYSIS Ó
SB 669
Page 1
SENATE THIRD READING
SB 669 (Huff)
As Amended September 3, 2013
Majority vote
SENATE VOTE :38-0
BUSINESS & PROFESSIONS 13-0 JUDICIARY 10-0
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|Ayes:|Gordon, Jones, Bocanegra, |Ayes:|Wieckowski, Wagner, |
| |Campos, Dickinson, | |Alejo, Chau, Dickinson, |
| |Eggman, Hagman, Holden, | |Garcia, Gorell, |
| |Maienschein, Mullin, | |Maienschein, Muratsuchi, |
| |Skinner, Ting, Wilk | |Stone |
| | | | |
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APPROPRIATIONS 17-0
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|Ayes:|Gatto, Harkey, Bigelow, | | |
| |Bocanegra, Bradford, Ian | | |
| |Calderon, Campos, | | |
| |Donnelly, Eggman, Gomez, | | |
| |Hall, Holden, Linder, | | |
| |Pan, Quirk, Wagner, Weber | | |
| | | | |
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SUMMARY : Permits a prehospital emergency medical care person or
lay rescuer to obtain and use an epinephrine auto-injector (EA)
in emergency situations with certification of training, as
specified. Specifically, this bill :
1)Permits a pharmacy to dispense EAs to a prehospital emergency
medical care person or lay rescuer for the purpose of
rendering emergency care, as specified, if both of the
following requirements are met:
a) A physician and surgeon provides a written order, as
follows, that specifies the quantity of EAs to be dispensed
to prehospital emergency medical care person or a lay
rescuer:
i) The physician and surgeon has issued the
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prescription upon presentation of a current certificate
demonstrating that the person is trained and qualified,
as specified, to administer an EA to another person in an
emergency situation; and,
ii) The prescription specifies that the dispensed EA is
for "First Aid Purposes Only" and that the named
recipient is a "Section 1797.197a Responder;" and a new
prescription is required for any additional EAs; and,
b) The pharmacy labels each EA 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
"First Aid Purposes Only"; and,
iii) The dosage, use, and expiration date.
c) Requires each dispensed prescription to include the
manufacturer's product information sheet for the EA.
2)Requires each person receiving EAs according to this bill to
make and maintain a record for five years reflecting dates of
receipt, use, and destruction of each EA dispensed, the name
of any person to whom epinephrine was administered using an
EA, and the circumstances and manner of destruction of any
EAs.
3)States that the EAs dispensed pursuant to this bill may only
be used for the following purposes and circumstances:
a) The EA is legally obtained by prescription from an
authorized health care provider 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 bill
or any other statute or regulation.
b) The EA is only used on another person, with the
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expressed or implied consent of that person, to treat
anaphylaxis;
c) The EA is stored and maintained as directed by the
manufacturer's instructions for that product;
d) The person using the EA has successfully completed a
course of training with an authorized training provider, as
specified, and has current certification of training issued
by the provider;
e) The EA obtained by prehospital emergency medical care
personnel, as specified, shall be used only when
functioning outside the course of the person's occupational
duties, or as a volunteer, pursuant to this bill; and,
f) The Emergency Medical Services System is activated as
soon as practicable when an EA is used.
4)Requires authorized training providers to be approved, and the
minimum standards for training and the use and administration
of EAs to be established and approved, by Emergency Medical
Services Authority (EMS).
5)Permits EMS to designate existing training standards for the
use and administration of EAs by prehospital emergency medical
care personnel to satisfy the requirements of this section.
6)Requires the following to be included in the minimum training
and requirements:
a) Techniques for recognizing circumstances, signs, and
symptoms of anaphylaxis;
b) Standards and procedures for proper storage and
emergency use of EAs;
c) Emergency follow-up procedures, including activation of
the Emergency Medical Services System, by calling the
emergency 911 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 EAs;
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e) Written material covering the information required under
this bill, including the manufacturer product information
sheets on commonly available models of EAs; and,
f) Completion of a training course in cardiopulmonary
resuscitation (CPR) and the use of an automatic external
defibrillator for infants, children, and adults that
complies with regulations adopted by EMS and the standards
of the American Heart Association or the American Red
Cross, and a current certification for that training.
7)States that certification of training shall be valid for no
more than two years, after which recertification with an
authorized training provider is required.
8)Authorizes the EMS director to deny, suspend, or revoke any
approval issued by this bill 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; or,
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 EA.
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9)Requires EMS to assess a fee pursuant to regulation sufficient
to cover the reasonable costs incurred by EMS for the ongoing
review and approval of training and certification.
10)Requires the fee to be deposited in the Specialized First Aid
Training Program Approval Fund (Fund), which is created in the
State Treasury, and all monies deposited in the fund shall be
made available, upon appropriation, to the authority for
purposes of authorizing training providers.
11)Permits EMS to transfer unused portions of the Fund to the
Surplus Money Investment Fund (SFund). Funds transferred to
the SFund shall be placed in a separate trust account, and
shall be available for transfer to the Fund, together with the
interest earned, when requested by EMS.
12)Requires EMS to maintain a reserve balance in the Fund of 5%
of annual revenues. Any increase in the fees deposited in the
Fund shall be effective upon determination by EMS that
additional moneys are required.
13)Exempts certain provisions of this bill for a school district
or county office of education, or its personnel, which
provides and utilizes EAs to provide emergency medical aid, as
specified.
14)States that this bill 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 EAs, or to
require additional training or certification beyond what is
already required under the other statute or regulation.
15)States that any person authorized by this bill who
administers an EA, 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 EA, if that person has complied with the
requirements and standards of this bill.
16)States that the liability exemption 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
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who renders emergency care treatment by the use of an EA.
17)States that nothing in this bill relieves a manufacturer,
designer, developer, distributor, or supplier of an EA of
liability under any other applicable law.
18)Defines the terms "Anaphylaxis," "EA," "Lay rescuer," and
"Prehospital emergency medical care person."
19)Makes clarifying and technical amendments.
20)States that no reimbursement is required by this act pursuant
to Section 6 of Article XIIIB 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 XIIIB of the California Constitution.
FISCAL EFFECT : According to the Assembly Appropriations
Committee:
1)One-time costs to EMSA of $500,000 General Fund (GF) over two
years to convene a task force, revise and create regulations
related to training standards, create an approval process for
training providers, and modify IT systems.
2)Ongoing costs to EMSA of $200,000 (special fund) annually to
review and update standards, and to approve training
providers.
3)Ongoing fee revenue of $200,000 to the Specialized First Aid
Training Approval special fund to support ongoing program
activities.
COMMENTS :
1)Purpose of this bill . This bill authorizes prehospital
emergency medical care personnel and lay rescuers to obtain
and use an EA in emergency situations after receiving
certification of training. This bill is aimed at expanding
the use of EA's by authorizing additional qualified personnel
to use them and granting immunity from civil liability when
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used properly. This bill is sponsored by Conference of
California Bar Associations.
2)Author's statement . According to the author's office,
California law permits school nurses and
trained personnel to obtain and use [EAs] to
provide emergency medical aid to students
experiencing anaphylactic shock, where
authorized by local school board or county
offices of education, and permits school nurses
and designated personnel to assist a student in
the self-administration of an epinephrine
auto-injector provided a current authorization
and release is on file. These laws are
consistent with laws adopted across the nation
reflecting the understanding that the timely
administration of epinephrine is essential to
avoiding serious injury or death in cases of
anaphylaxis, and that epinephrine
auto-injectors - which contain carefully
metered doses of this life-saving medication -
are safe to administer by properly trained
individuals. [EAs] are safe, consumer-friendly,
in widespread distribution, intended to be
carried and self-administered by adults and
even children to protect against
life-threatening anaphylactic shock.
The problem is that the risk of anaphylaxis is
not limited to children, nor is it limited to
school or home. Suffocation and death from an
anaphylactic reaction to substances can occur
anywhere, anytime, to anyone, without warning
or adequate time to obtain definitive medical
care. Under current law, it is illegal for
first responders to possess or carry [EAs] to
save lives for anyone else suffering
anaphylaxis, be it in the wilderness, or even
in the community where medical care cannot be
timely obtained. Not everyone who has been
prescribed an [EA] will have it at the time of
need. Not everyone who has one will be able to
self-administer it in time. Further, not
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everyone who suffers a potentially lethal
anaphylactic reaction will have known of their
allergic predisposition in advance, much less
have had an [EA] prescribed. Yet, people are
unnecessarily exposed to the real risk of
death. People die from anaphylaxis because what
they need---epinephrine---is not always readily
available by someone who can legally administer
it.
SB 669 addresses this real but unnecessary
problem. It allows those group leaders or first
responders who successfully complete a
certified training course, to obtain and use
[EA] to provide life-saving first aid in the
event of anaphylaxis, just as many are already
trained and authorized to do in rendering
immediate CPR, administering a shock from an
automatic external defibrillator, applying
tourniquets for unremitting life-threatening
hemorrhage, and effectuating emergency
evacuations even in face of spinal injuries.
And, like other Good Samaritan laws, it
provides immunity to properly certified
individuals from civil liability, except in
cases of gross negligence.
3)Epinephrine and auto-injectors . According to the National
Institutes of Health, an epinephrine injection is used along
with emergency medical treatment to treat life-threatening
allergic reactions caused by insect bites or stings, foods,
medications, latex, and other causes. Epinephrine works by
relaxing the muscles in the airways and tightening the blood
vessels.
An auto-injector is usually a type of easy-to-use spring-loaded
syringe, intended for self-administration by the patient or by
untrained personnel.
4)Providers currently authorized to administer EAs . In addition
to certain licensed healthcare professionals, existing law
permits a school nurse or other qualified person designated by
the school district physician, the medical director of the
local health department, or the local emergency medical
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services director to administer an EA. This bill would permit
prehospital emergency medical care persons, and lay rescuers
to obtain and administer EAs with proper training and
certification as well.
5)EA authorization in other states . According to information
provided by the author's office, seven states (Arkansas,
Florida, Maryland, Missouri, North Carolina, North Dakota, and
South Carolina) have certificate programs for lay rescuers,
typically providing for the training and certification of
persons who reasonably expect to have responsibility for
others as a result of occupational or volunteer status, such
as camp counselors, forest rangers, and tour guides.
Certified persons are authorized to obtain EAs and are granted
"Good Samaritan" liability protection.
Six other states also provide some form of immunity for EA
use. Three states provide Good Samaritan immunity for persons
who have received authorized training (Connecticut, New York,
and Oregon), and more three states deem that the
administration of epinephrine by a volunteer rescuer in an
emergency is entitled to Good Samaritan protection (Arizona,
Rhode Island, and Virginia).
Analysis Prepared by : Sarah Huchel / B.,P. & C.P. / (916)
319-3301
FN: 0002268