BILL ANALYSIS
SENATE JUDICIARY COMMITTEE
Martha M. Escutia, Chair
2003-2004 Regular Session
AB 1369 A
Assembly Member Pavley B
As Amended August 18, 2003
Hearing Date: August 19, 2003 1
Health and Safety Code 3
GWW:cjt 6
9
SUBJECT
Automatic External Defibrillators (AEDs):
Mandated Placement in Residential Care Facilities for the
Elderly
DESCRIPTION
This bill would, as of July 1, 2005 and until January 1, 2010,
require every residential care facility for the elderly (RCFE)
with a licensed bed capacity of over 60 persons, to acquire,
maintain, and train personnel in the use of automatic external
defibrillators (AEDs), as specified. Employees of such a
facility, and the board of directors, and the facility itself
would be immunized from civil liability for injuries resulting
from an employee's rendering emergency care with an AED,
except for injury or death that results from gross negligence
or wilfull or wanton misconduct. A facility's immunity would
be further conditioned upon the facility complying with
specified maintenance, training, and staffing requirements.
(This immunity would track the immunity provided by existing
law to building owners who voluntarily install AEDs in their
buildings.) The civil immunity provisions of the bill would
also apply to RCFEs with less than 60 licensed beds that elect
to install an AED.
The bill would require the mandated RCFEs to give current and
new residents (including hospice residents) the opportunity to
file a statement declining the use of an AED in emergency
situations. Unless the resident affirmatively acts to opt
out, an AED would be used on a resident in an emergency
situation even if the resident otherwise had a DNR
(do-not-resuscitate) directive on file.
(more)
AB 1369 (Pavley)
Page 2
(This analysis reflects author's amendments to be offered in
Committee.)
BACKGROUND
An AED is a small, lightweight medical device used to assess a
person's heart rhythm and, if necessary, administer an
electric shock through the chest wall to restore a normal
heart rhythm in victims of sudden cardiac arrest. Built-in
computers assess the patient's heart rhythm, determine whether
the person is in cardiac arrest, and signal whether to
administer the shock. Audible cues guide the user through the
process. Portable AEDs are available upon a prescription from
a medical authority. Their general cost is about $2,500 to
$3,000 per unit.
According the American College of Emergency Physicians (ACEP)
website, when a person suffers a sudden cardiac arrest,
chances of survival decrease by 7 to 10 percent for each
minute that passes without defibrillation. A victim's best
chance for survival is when there is revival within four
minutes. However, AEDs are less successful when the victim
has been in cardiac arrest for more than a few minutes,
especially if no cardiopulmonary resuscitation (CPR) was
provided.
The ACEP supports increased public access to AEDs that is
coordinated with community medical services systems and with
appropriate training.
In 1999, the Legislature enacted SB 911 (Figueroa) to provide
a qualified immunity from civil liability for trained persons
who use in good faith and without compensation an AED in
rendering emergency care or treatment at the scene of an
emergency. The qualified immunity would also extend to those
businesses that purchased the device, the medical authority
that prescribed the device, and the agency that trained the
person in the AED use, provided that specified training and
maintenance requirements were met. The immunities do not
apply in cases of personal injury resulting from gross
negligence of wilfull or wanton misconduct.
In 2002, the Legislature enacted AB 2041 (Vargas), Chapter
718, Statutes of 2002, to modify the conditions for immunizing
the AED user and purchasing business. It eliminated the CPR
AB 1369 (Pavley)
Page 3
and AED-use training requirements for users and relaxed the
facility's training and staffing requirements. AB 2041 was
enacted with a five-year sunset to allow an assessment of its
broader immunity provisions.
Both SB 911 and AB 2041 provided a qualified immunity to those
entities that voluntarily purchased an AED for placement and
use in their buildings. This bill would provide a similar
qualified immunity to specified RCFEs (those having a licensed
bed capacity of over 60 persons) that would be required by
this bill to acquire, maintain and train personnel in the use
of AEDs.
CHANGES TO EXISTING LAW
Existing law , Health and Safety Code Section 1797.190,
provides that the Emergency Services Authority may establish
minimum standards for the training and use of AEDs by
individuals not otherwise licensed or certified for its use.
Existing law , Civil Code Section 1714.21, immunizes from civil
liability:
(1) Any person who, in good faith and not for compensation
renders emergency treatment by the use of an automated
external defibrillator (AED) at the scene of an emergency.
(2)A person or entity (e.g., a building owner) who provides
CPR and AED training to a person who renders emergency
care pursuant to (1) above.
(3)A person or entity that acquires an AED for emergency
use if the person or entity has complied with specified
training and staffing requirements, as set forth in
subdivision (b) of Section 1797.196 of the Health and
Safety Code.
This immunity does not apply in cases of gross negligence or
willful or wanton misconduct.
Existing law , Health and Safety Code Section 1797.196(b)
provides any person or entity that acquires an AED with an
immunity from liability for its use by any person rendering
emergency care under Civil Code Section 1714.21, if the person
or entity complies with all regulations governing the
placement of the AED and ensures all of the following:
That the AED is regularly maintained and regularly
tested according to the operation and maintenance
AB 1369 (Pavley)
Page 4
guidelines set forth by the manufacturer;
That the AED is checked for readiness after each use
and at least once every 30 days if the AED has not been
used in the preceding 30 days. Records of these periodic
checks are also required;
That any person who renders emergency care or
treatment by using an AED activates the emergency medical
services system as soon as possible, and reports any use
of the AED to the licensed physician and to the local
Emergency Medical Services (EMS) agency;
That for every AED unit acquired up to five units, no
less than one employee per AED unit shall complete a CPR
training course that complies with specified standards;
That acquirers of AED units shall have trained
employees who should be available to respond to an
emergency that may involve the use of an AED unit during
normal business hours;
That there is involvement of a licensed physician in
developing a program to ensure compliance with the
regulations and requirements for training, notification,
and maintenance; and
That building owners prepare a written plan describing
the procedures to be followed in the event of an
emergency requiring the use of an AED. The plan shall
require the user to immediately notify "911" and trained
office personnel at the start of AED procedures.
Existing law authorizes by regulation, but does not require,
RCFEs to maintain and operate an AED, subject to compliance
with all applicable federal and state requirements. These
regulations require the licensee to comply with certain notice
and AED maintenance requirements, but varies from Section
1797.196(b) in that it requires the training in CPR and AED
use of at least one employee per AED unit in the RCFE
(compared to one employee per five units). Like Section
1797.196(b), the regulations requires a RCFE to have trained
employees who should be available to respond to an emergency
that may involve the use of an AED unit during normal
operating hours. Also, the regulations specify that RCFEs
operating AEDs must observe a do-not-resuscitate (DNR) order,
advance directives, and requests to forego resuscitative
measures.
This bill would, beginning July 1, 2005 and until January 1,
2010, require every RCFE with a licensed bed capacity of over
60 persons, to acquire, maintain, and train personnel in the
AB 1369 (Pavley)
Page 5
use of AEDs pursuant to any standards developed by the
Emergency Services Authority, any other relevant regulations,
and as specified by this bill. Employees of such a facility,
and the board of directors, and the facility itself would be
immunized from civil liability for injuries resulting from an
employee's rendering emergency care with an AED, except for
injury or death that results from gross negligence or wilfull
or wanton misconduct. A facility's immunity would be further
conditioned upon the facility complying with specified
maintenance, training, and staffing requirements. (The
conditions for this immunity would track the same conditions
set forth in existing Section 1797.196(b) - set forth above -
which apply to public or private building owners who
voluntarily install AEDs in their buildings.)
The bill would require the mandated RCFEs to give information
about AED use to all current and new residents, including
those receiving hospice services and those with a DNR
directive, and provide them with the opportunity to file a
separate statement declining the use of an AED in emergency
situations. Unless the resident files an opt-out statement, a
RCFE's employee could use the AED (and CPR) on that resident
in medical emergencies. The bill would require the RCFE to
repeat this process for current residents to opt-out of AED
use at least once every two years.
The bill would also require the mandated RCFEs to:
Establish policies to address the presentation,
processing, maintenance, revision, and
information-dissemination of declination statements.
Provide lists of those residents signing a declination
statement to the CPR and AED-use trained employees, to
maintain a copy of that list with each AED maintained in
the facility, and to maintain a copy of each declination
statement in the resident's file.
This bill would authorize the Department of Social Services to
adopt emergency regulations to implement its provisions, and
would exempt the initial emergency regulations and the first
readoption from review by the Office of Administrative Law.
The emergency regulation and its first readoption would be
effective for up to 180 days.
This bill would also direct the Emergency Service Authority to
encourage local EMS agencies to track the uses of AEDs on
residents of RCFEs.
AB 1369 (Pavley)
Page 6
COMMENT
1. Stated need for mandatory placement of AEDs in RCFEs
According to the author, "At least 450,000 cases of
unexpected cardiac arrest occur annually in the United
States, and the majority of these cases occur in places
other than hospitals. Studies have shown that when
defibrillators are used immediately on cardiac arrest
victims, the survival rate is almost 100 percent. But
because traditional emergency medical services take 8 to 15
minutes to respond, the overall survival rates for cardiac
arrest victims in most U.S. communities are only 5 to 10
percent."
The author further notes that despite the proven success of
quick defibrillation, and the availability of AEDs that can
be easily placed in a variety of locations and used by
non-medical personnel, facilities that house and care for
senior citizens oftentimes do not have AEDs on the
facilities' premises.
In support, the California Senior Legislature, sponsor of AB
1369, writes that AB 1369 is one of the Top Ten State
Priority Proposals from its 22nd Annual Session that
concluded in October 2002. The proposal is a priority for
seniors because, according to a 1998 American Heart
Association study, 84.2% of those who die of sudden cardiac
arrest are 65 years old or older.
2. Opposition to mandatory placement by RCFEs
According to the Senate Health Committee analysis, about 600
RCFEs would be affected by AB 1369's mandate. (An RCFE is a
housing arrangement chosen by persons 60 years of age or
over, or their authorized representative, where varying
levels and intensities of care and supervision, protective
supervision, or personal care are provided, based upon their
varying needs. Assistance may include assistance with
taking medications, money management, or personal care.)
Groups representing the RCFEs and other assisted living
facilities strongly oppose AB 1369, primarily because of
concerns over liability, feasibility, costs, and the
"opt-out" provision with its potential attendant management
AB 1369 (Pavley)
Page 7
problems. Groups representing hospice patients also oppose
application of the opt-out provision to hospice patients who
have already affirmatively accepted only pallative or
comfort care. These opposition points are discussed below.
a) Liability concerns
Opponents assert that RCFEs should not be singled out for
mandatory placement of AEDs, and that such a mandate
would create liability problems and increase liability
insurance premiums which have already soared in recent
years. Instead, they urge the adoption of a pilot
program promoting the voluntary use of AEDs.
The recent August 18th amendments respond to this
concern, although not perhaps to the opposition's entire
satisfaction. As amended, the bill confers the same
immunity to RCFEs as the immunity given under existing
law to building owners who voluntarily install AED units
in their buildings. The provisions of subdivision (e) of
proposed Section 1569.7, beginning on page 3, line 40,
through page 5, line 2, are taken directly from existing
law, Heath and Safety Code Section 1797.196(b). In fact,
the amendments reduce the training requirements that
RCFEs must meet in order to obtain the immunity. Under
current regulations, an RCFE must have one trained person
per installed AED. Under AB 1369, pursuant to AB 2041
(Vargas), the RCFE would only be required to train one
person for every five AEDs installed. (However, a
separate staffing requirement - to have a trained
employee able to respond to emergency situations on hand
"during normal business hours" is retained. As RCFEs are
24-hour operations, this requirement (like the current
regulations) would likely require the training of at
least six employees to satisfy 24 hours a day, 7 days a
week, normal business hours of a RCFE.)
While some of the opposition had argued for a broad
immunity, similar to that afforded to "Good Samaritan"
users (who are not required to be trained for the
immunity), the better public policy, as articulated by
the American College of Emergency Physicians, is to
promote public access to AEDs that is coordinated with
community EMS systems and with appropriate training.
Thus, AB 1369 would confer the same immunity, with the
AB 1369 (Pavley)
Page 8
same training and maintenance requirements, for RCFEs as
that granted under existing law to building owners that
voluntarily install AEDs in their buildings.
(Reportedly, the required AED/CPR training course can be
completed in 4 hours at a cost of about $45 per
participant.)
b) Concerns that mandatory placement of AEDs in RCFEs is
not appropriate
Opponents also contend AB 1369 is not likely to be the
life saving measure that the author intends because of
the nature of the population in RCFEs and the fact that
many (reportedly a majority in most facilities) residents
have express DNR directives on file. They also object to
the imposition of the additional costs of purchasing the
units and training their employees for private facilities
when the state has yet to impose similar mandates on
public facilities.
One opponent, the California Assisted Living
Association (CALA) contends that the typical RCFE
resident is over 80 years of age and experiencing some
degree of failing health, with many of them having a DNR
directive on file. CALA and other opponents question why
AEDs placement should be mandated in a setting where a
high concentration of people have already indicated they
do not want to be resuscitated?
Another opponent, the California Association of Homes
and Services for the Aging (CAHSA), argues that the frail
80+ year-old RCFE resident is not an appropriate
candidate for CPR. (The administration of CPR, which
precedes the AED use, is absolutely necessary for
effective AED use. Because the supply of oxygen-rich
blood to the brain is cut off when the heart stops
pumping, people who survive a cardiac arrest lasting more
than a few minutes often suffer brain damage. Thus, CPR
supplies the breathing support to keep oxygen flowing to
the brain pending restoration of the heart rhythms.)
CAHSA argues that the old age and frail condition of
the typical RCFE resident makes CPR a dangerous treatment
option. "Cracked ribs and broken bones are not uncommon
with CPR on middle age patients. With 80+ age patients
with or without osteoporosis, CPR will break fragile
AB 1369 (Pavley)
Page 9
bones, bruise organs, and could cause internal bleeding.
RCFEs by law are not equipped to handle the follow-up
that is immediately necessary after applying CPR to frail
residents," writes CAHSA.
The author's office responds that mandated placement
in RCFEs would benefit the many other seniors in those
facilities who do not opt out. The unit could also be
available for use on visitors who suffer a cardiac
arrest.
On the issue of potential injury from CPR, the author's
staff responds that while the resident might receive some
injuries in the course of the CPR, that resident's
chances of survival and retaining a normal life are
markedly improved with timely CPR and AED intervention.
According to a recent report in the New England Journal
of Medicine, cardiac arrest patients who survive having
their heart shocked with a portable AED can go on to lead
lives that are just as long and as full as people with
similar heart conditions who've never had a cardiac
arrest. Of the 200 original patients in the study, 42
percent lived long enough to leave the hospital, and
almost all of those patients (79 of 84) were free of
disabling neurological problems. In contrast, the
traditional survival rate for cardiac arrest victims
outside a hospital is three percent to 10 percent. In
short, the author's office argues: "it is better for the
resident to have a broken bone or bruises than being
dead."
The author's office also responds that not all RCFE
residents are as frail or elderly as the opponents argue.
Many are capable of independent existence, and are able
to drive their own cars and lead independent lives just
like any other senior citizen.
c) Issue of pre-existing DNR and whether AB 1369
nullifies that directive
A very difficult issue is whether AB 1369's "opt-out"
process violates the wishes of a RCFE patient, including
one there for hospice service, who had prepared and filed
a DNR. Under AB 1369, that resident and any other
AB 1369 (Pavley)
Page 10
resident would have to file a separate statement to
decline the AED use. Thus, unless that separate
declination is made, a RCFE resident who has a DNR
directive on file could have an AED used to attempt to
resuscitate him or her in a cardiac arrest emergency,
notwithstanding the DNR.
The Calif. Hospice and Pallative Care Association, as
well as the Compassion in Dying Federation and other
opponents, oppose this policy of AB 1369. They argue
that it waters down the effectiveness of an existing DNR
and other advanced directives, thus creating confusion
and possibly resulting in the unintended resuscitation of
a person who did not wish resuscitation. Particularly
with a high risk of brain damage when breathing rhythms
are not restored within minutes (by either CPR or AED
usage), persons filing a DNR to avoid "living as a
vegetable" could find their intents and wishes thwarted.
The author's office responds all RCFE residents (or their
representatives) will be given the full opportunity to
sign a separate statement rejecting the use of AEDs.
Thus, she argues, DNR wishes and intents will not be
thwarted.
Opponents also contend that since a great many RCFE
residents already have a DNR directive on file, including
hospice residents who desire only pallative care, that AB
1369 should provide for an "opt-in" process instead.
The author responds that the "opt-out" process is
necessary because RCFE employees cannot legally abide by
a DNR or other advance directive. She explains that
because RCFEs employees are non-licensed, non-medical
personnel, they are not legally authorized to honor or to
assume responsibility for a DNR order. Instead, in cases
of emergency, they must call 9-1-1 and present the DNR
order to responding medics. Thus, without this "opt-out"
process, trained RCFEs would be directed to use the AED
on any cardiac arrest victim in the RCFE, even those with
a DNR or other advance directive.
Alternatively, the law, like the current regulations,
could require the RCFE to observe a DNR and other advance
directives. If that were the case, an "opt-in" process
AB 1369 (Pavley)
Page 11
could be utilized.
d) Concerns that RCFE employees are not qualified to
handle AED responsibilities, which would lead to
increased liability
Opponents point out that typical RCFE employees are
unlicensed employees who have no training in medical
procedures or devices. Indeed, their function, to assist
seniors in the facility, may not even require a high
school education.
Thus, opponents express concern whether these
employees are equipped to handle the AED
responsibilities, and whether AB 1369's proposed process
for listing those who have rejected AED use, is
sufficient to ensure appropriate usage and not expose the
RCFE to unwanted liability.
3. January 1, 2010 sunset is proposed, to allow future
assessment of impact
In light of the various concerns raised by the opposition,
not all of which are addressed by the August 18th
amendments, and in light of the lack of empirical data
demonstrating that the benefits of mandatory placement of
AEDs in RCFEs (and how many will opt-out, thus reducing its
impact) and the monetary and potential liability costs
imposed upon RCFEs (which most likely will be passed onto
consumers), Committee staff strongly suggested, and the
author and sponsors have accepted, a 4 year sunset of the
bill so that the Legislature can revisit this issue and make
appropriate changes, if necessary, in light of the actual
experience under AB 1369.
4. Application of immunity to smaller RCFEs electing to install
AEDs; amendment needed for appropriate implementation
Proposed subdivision (l), on page 7, lines 23 through 26,
would apply the immunity provisions of AB 1369 [subdivisions
(b), (c), and (d)] to RCFEs with a licensed bed capacity of
60 or fewer persons, that elect to install an AED in the
facility. However, to implement those provisions, other
provisions also need to be made applicable.
For example, subdivision (g) sets forth the proposed
AB 1369 (Pavley)
Page 12
"opt-out" process. Without that provision, it is unclear
how these RCFEs would respond in cardiac arrest patients
with a DNR directive. Would the current regulations that
require the RCFE to observe a DNR control? Similarly, AB
1369 omits application of subdivision (h) to these RCFEs.
That subdivision sets forth a process for RCFEs to inform
their residents about the AEDs, and to maintain a list of
those residents who have opted out of AED use. It is
unclear how these RCFEs would address the implementation
concerns in the absence of the specified procedures.
Perhaps the omission was an oversight. In any case,
assuming this Committee agrees with the proposed opt-out
process, Committee staff recommends the following amendment
to facilitate implementation:
On page 7, line 26, after the period insert:
In the event of that election, the provisions of
subdivisions (g) and (h) shall apply.
5. Very small chance of misuse or misapplication, asserts AHA
According to the AHA, AEDs contain microcomputers to
accurately identify sudden cardiac arrests and make
extensive use of audible prompting and signals to provide
operators with clear and concise instruction, making their
use uncomplicated, intuitive, and nearly foolproof. AHA's
website states that "an AED will almost never decide to
shock an adult victim when the victim is in non-VF
(ventricular fibrillation: irregular heart rhythm). AEDs
'miss' fine (sic) VF only about 5% of the time. The
internal computer uses complex analysis algorithms to
determine whether to shock?. The AED will make the correct
'shock' decision more than 95 of 100 times and a correct 'no
shock indicated' decision in more than 98 of 100 times.
This level of accuracy is greater than the accuracy of
emergency professionals."
AHA also reports that the device does not allow for manual
overrides, in the event a panicked operator tries to
administer the shock even when the device finds that the
victim is not in cardiac arrest.
Intentional misuse would not be covered by the qualified
immunity.
AB 1369 (Pavley)
Page 13
6. Technical amendments
The following are suggested for clarity and grammar
purposes.
a) On page 3, in lines 5 and 6, the language
should read:
bed capacity that exceeds 60 persons shall acquire,
maintain, and train personnel in the use of an acquire
and maintain, and train personnel in the use of, an
automatic external
Read literally, the current language would require the
acquisition and maintenance of people instead of the AEDs
in question.
The same changes are necessary for page 7, lines 25
and 26.
b) On page 3, strike out lines 9 and 10 and insert (for
better readability):
pursuant to subdivision (e) of this section, Section
1797.190, and any relevant regulations.
c) On page 5, line 36, strike out "resident" and insert:
resident's
Support: Commission on Aging; American Heart Ass'n.; American
Red Cross of CA;
Calif. Professional Firefighters Ass'n.; Congress
of Calif. Seniors;
Emergency Medical Services Administrators' Ass'n.;
Federation of Retired
Union Members of Santa Clara and San Benito
Counties; Medtronic
Physio-Control; Older Women's League of
California; Triple-A Council
of CA.
Opposition: ARV Assisted Living, Inc.; Calif. Assisted Living
Ass'n.; Calif. Ass'n for Health Services at Home;
AB 1369 (Pavley)
Page 14
Calif. Ass'n of Homes and Services for the Aging;
Calif. Ass'n of Long Term Care Medicine; Calif.
Hospice and Pallative Care Ass'n.; Hospices
Partners; San Carlos Elms; Summerville at Casa
Whittier; Compassion in Dying Federation; Pathway
Home Health and Hospice
HISTORY
Source: California Senior Legislature
Related Pending Legislation: None Known
Prior Legislation: AB 2041 (Vargas), Chapter 718, Statutes of
2002
SB 911 (Figueroa), Chapter 163, Statutes of
1999
Prior Vote: Senate Health and Human Services: 7 - 3
Assembly Floor: 53 - 22
Assembly Health Committee: 5 - 0
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