[Federal Register Volume 74, Number 156 (Friday, August 14, 2009)]
[Notices]
[Pages 41133-41139]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19555]


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GENERAL SERVICES ADMINISTRATION

[FMR Bulletin 2009-B2]


Guidelines for Public Access Defibrillation Programs in Federal 
Facilities

AGENCY: Department of Health and Human Services and General Services 
Administration.

ACTION: Notice.

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SUMMARY: On May 23, 2001, the Department of Health and Human Services 
(HHS) and the General Services Administration (GSA) jointly issued 
``Guidelines for Public Access Defibrillation Programs in Federal 
Facilities.'' 66 FR 28495-28501. These guidelines were prepared, in 
part, in response to a May 19, 2000, Presidential Memorandum directing 
HHS and GSA to issue guidelines for the placement of automated external 
defibrillator (AED) devices in Federal buildings. In addition, section 
7 of the Healthcare Research and Quality Act of 1999, Public Law 106-
129 (December 6, 1999), 42 U.S.C. 241 note, and section 247 of the 
Public Health Service Act, 42 U.S.C. 238p (as added by section 403 of 
the Public Health Improvement Act, Pub. L. 106-505 (November 13, 
2000)), directed the Secretary of HHS to establish and publish the 
guidelines.
    This bulletin cancels and replaces the May 23, 2001, notice and 
provides updated information for establishing public access 
defibrillation (PAD) programs in Federal facilities.
    The revised guidelines provide a general framework for initiating a 
design process for PAD programs in Federal facilities and provide basic 
information to familiarize facilities leadership with the essential 
elements of a PAD program. The guidelines do not exhaustively address 
or cover all aspects of AED or PAD programs. They are aimed at 
outlining the key elements of a PAD program so that facility-specific, 
detailed plans and programs can be developed in an informed manner.
    PAD programs are voluntary and are not mandatory for Federal 
facilities. The costs and expenses to establish and operate a PAD 
program are the responsibility of the agency sponsoring the program and 
not GSA or HHS.

DATES: Effective Date: August 14, 2009.

FOR FURTHER INFORMATION CONTACT: For further clarification of content, 
contact Stanley C. Langfeld, Director, Regulations Management Division 
(MPR), General Services Administration, Washington, DC 20405; or 
<a href="/cdn-cgi/l/email-protection#47343326292b223e692b26292021222b230720342669202831"><span class="__cf_email__" data-cfemail="5f2c2b3e31333a2671333e3138393a333b1f382c3e71383029">[email protected]</span></a>.

    Dated: August 7, 2009.
Stanley Kaczmarczyk,
Acting Associate Administrator for Governmentwide Policy, General 
Services Administration.
Howard Koh,
Assistant Secretary for Health, Department of Health and Human 
Services.

Public Buildings and Space

    To: Heads of Executive Agencies.

[[Page 41134]]

    Subject: Guidelines for Public Access Defibrillation Programs in 
Federal Facilities.
    1. Purpose. The primary purpose of these guidelines is to provide a 
general framework for initiating a design process for a public access 
defibrillation (PAD) program in Federal facilities. A secondary purpose 
is to familiarize Federal agencies with the essential elements of such 
a program. The design of a PAD program for any Federal facility will be 
unique and depends on many factors, including the population 
demographics of the facility and the surrounding area, and the size and 
location of the facility and the surrounding area. The design process 
and key elements of a PAD program described in these guidelines are 
intended to provide a foundation upon which individually tailored 
programs are developed and implemented.
    This document is not intended to be a comprehensive summary of all 
aspects of automated external defibrillator (AED) use or establishing 
and operating PAD programs. Rather, it provides sufficient information 
to understand the basic key elements of a program and to launch an 
effective planning and implementation process. There are numerous 
sources for training and education programs as well as model protocols 
that can be used at various stages in the process. The required medical 
consultation can be obtained from Federal sources (see, for example, 
Federal Occupational Health--http://www.foh.dhhs.gov/services/AED/AED.asp) or private contractors.
    It is important to note that PAD programs are voluntary and are not 
mandatory for Federal facilities. The costs and expenses to establish 
and operate a PAD program are the responsibility of the agency 
sponsoring the program and not the General Services Administration 
(GSA) or the Department of Health and Human Services.
    2. Expiration Date. This bulletin contains information of a 
continuing nature and will remain in effect until canceled.
    3. General. Over the past several years, advances in technology 
have provided several innovative opportunities to prevent unnecessary 
disability and death. One of the most important of these advances is 
the AED. The ease of use of AEDs by the trained lay public has led to 
the increasing development of PAD programs. The decreased cost of 
acquisition and upkeep of AEDs now makes it possible to increase 
further the availability and access to these lifesaving devices.
    Ventricular fibrillation (VF) is a common arrhythmia leading to 
cardiac arrest and death. VF is unorganized electrical activity of the 
heart, resulting in no blood flow or pulse that will lead to death. 
Defibrillation is the only technique that is effective in returning a 
heart in VF to its normal rhythm. Although defibrillation has been 
shown to be effective in correcting this abnormality in most cases, up 
until the advent of AEDs defibrillation has been a medical intervention 
only available to be performed by credentialed health professionals and 
trained emergency medical service personnel. While it is difficult to 
use an AED improperly, AEDs are not without risks, if used improperly. 
AEDs are generally prescription devices that are intended to be 
operated only by individuals who have received proper training and 
within a system that integrates all aspects from first responder care 
to hospital care. Hence, a significant emphasis on proper training and 
linkage (notification or transfer) to emergency medical services (EMS) 
systems is critical. The value of the AED technology is that an AED 
will not energize unless an appropriate shockable cardiac rhythm is 
detected.
    The efficacy of defibrillation is tied directly to how quickly it 
is administered. Although the outside limit of the ``window of 
opportunity'' in which to respond to a victim and take rescue actions 
is approximately 10 minutes, the sooner the AED is applied within that 
time period, the more likely it is that it will be effective and that a 
patient will have a normal heart beat restored and recover fully. As 
the length of time between the onset of Sudden Cardiac Arrest (SCA) and 
defibrillation increases, the less the chance of restoration of heart 
beat and full recovery. In general, for every minute that passes 
between the event and defibrillation, the probability of survival 
decreases by 7 to 10 percent. After 10 minutes, the probability of 
survival is extremely low.
    Today's AEDs are relatively inexpensive and usable by persons with 
limited training. The advantage of well structured PAD programs is that 
they provide better trained individuals and increase accessibility and, 
as a result, increase the potential to reduce response times and 
markedly increase the probability of survival and full recovery.
    The importance of rapid and positive intervention is reflected in 
the American Heart Association's (AHA's) ``Chain of Survival'' concept. 
The ``Chain of Survival'' is designed to optimize a patient's chance 
for survival of SCA. There are four links in the chain: (1) Early 
access, (2) early cardiopulmonary resuscitation (CPR), (3) early 
defibrillation, and (4) early advanced cardiac life support.
    Early access is the first link in the chain of survival and means 
that members of the workplace have been trained to recognize possible 
cardiac arrest quickly and notify EMS (i.e., call 911) of the event 
resulting in activation of an EMS response.
    The second link in the chain of survival is to begin CPR 
immediately. CPR is the critical link that buys time between the first 
link (notification of EMS) and the third link (use of the AED). The 
earlier you administer CPR to a person in cardiac or respiratory 
arrest, the greater their chance of survival. CPR keeps oxygenated 
blood flowing to the brain and heart until defibrillation or other 
advanced care can restore normal heart activity. CPR may be 
administered by a trained responder or an untrained bystander who has 
witnessed an individual experiencing SCA. In a witnessed SCA situation, 
trained responders may use either conventional CPR or ``hands-only'' 
CPR. Untrained responders may use ``hands-only'' CPR in a witnessed SCA 
situation. In an un-witnessed SCA situation, conventional or ``hands 
only'' CPR may be used by trained responders. The AHA clarified this 
approach to CPR in an SCA situation in March 2008, when it updated 
previous CPR guidelines for witnessed adult SCA to include ``hands-
only'' CPR (see, http://handsonlycpr.eisenberginc.com/faqs.html#a). 
These guidelines noted that there was a need to increase the prevalence 
and quality of bystander CPR. The use of ``hands-only'' CPR is meant to 
encourage earlier CPR intervention by untrained bystanders and trained 
bystanders who are not confident that they can perform conventional 
CPR. Early CPR by trained or untrained bystanders provides precious 
minutes for trained AED responders as well as EMS teams to arrive.
    Early defibrillation (use of the AED) is the third link in the 
chain of survival. Many SCA victims are in VF, experiencing a lethal, 
chaotic heart rhythm that prevents the heart from effectively pumping 
blood. You must defibrillate a victim immediately to stop VF and allow 
a normal heart rhythm to resume. The sooner you provide defibrillation 
with the AED device, the better the victim's chances of survival. 
Several studies have documented the effects of time to defibrillation 
and the effects of bystander CPR on the chances of survival from SCA. 
For every minute that passes between collapse and

[[Page 41135]]

defibrillation, survival rates from witnessed VF SCA decrease 7 to 10 
percent, if no CPR is administered.
    The fourth link in the chain of survival is early advanced care. 
This link is provided by highly trained EMS personnel. EMS personnel 
give basic life support and defibrillation as well as more advanced 
care that can help the heart respond to defibrillation and maintain a 
normal rhythm after a successful defibrillation.
    The material in these guidelines is based upon the recommendations, 
programs and literature on AEDs from the AHA and the American Red Cross 
(ARC), leaders in the encouragement of AED installation, training and 
usage. The AHA and ARC cooperate with other organizations in developing 
and improving standards for AEDs. Users of this guidance should check 
the latest AHA, ARC and National Safety Council (NSC) information for 
updates or changes to the recommendations.


    Special Note:  As is the case with most clinical developments, 
the science-supporting efficacy in controlled settings usually 
precedes evidence of effectiveness when implemented large-scale in 
real world settings. The science surrounding the effectiveness of 
AEDs, as well as the technology of AEDs themselves, is evolving.


    For Federal agencies in space under the jurisdiction, custody or 
control of GSA, the Designated Official under the facility's Occupant 
Emergency Plan (as defined in 41 CFR 102-71.20) is responsible for 
oversight of the facility's PAD program. As provided in 41 CFR 102-
71.20, the Designated Official is the highest-ranking official of the 
primary occupant agency of a Federal facility, or, alternatively, a 
designee selected by mutual agreement of occupant agency officials 
(see). AED programs should evolve based on the best available science 
to assure the most efficient use of resources and the best outcomes 
possible.
    4. The Concept of Public Access Defibrillation. Until recently, 
AEDs and other defibrillation devices had to be brought to locations by 
the local EMS system. The size, cost and complexity of these devices, 
as well as other factors, served to limit their use. With recent 
advances in technology, many of the previous constraints have been 
reduced or eliminated. Increasingly, AEDs are being deployed in public 
facilities, such as sports arenas, shopping malls and airports, or in 
police and fire units, thus potentially decreasing the time between 
cardiac arrest and access to defibrillation.
    However, optimal improvement in survival from SCA that occurs in a 
non-medical setting may require a program that relies upon community 
lay (i.e., non-medical) responders or rescuers (LRRs) who have been 
trained in CPR and in the appropriate use of AEDs. A comprehensive, 
well integrated community approach to the use of AEDs would serve a 
large proportion of that community (e.g., a facility, a campus, etc.). 
LRRs could quickly respond to, identify and treat a cardiac arrest 
patient and activate the formal EMS system.
    ``Public access'' to AEDs does not mean that any member of the 
public who witnesses an event should be able to use an AED. ``Public 
access'' refers to the accessibility of the device itself. While AEDs 
are reasonably uncomplicated to use, the AED should be used only by 
persons who have received proper training and education from a 
nationally recognized training institution or association. Persons 
without these basic credentials should not use the device.
    5. Establishing a Public Access Defibrillation Program in a Federal 
Facility. Before establishing a program in a Federal facility, each 
agency should enlist the assistance of not only the personnel at that 
location, but also local training, medical and emergency response 
resources. These partnerships are fundamental to any successful PAD 
program. In some instances, a facility may be large enough to have 
training, medical and emergency response resources integral to Federal 
operations. For the most part, this will be the exception rather than 
the rule, but the same principles apply. The more closely the PAD 
program is connected to such resources and the more visibility and 
support given to the program by the facility leadership, the more the 
program will be effective and successful.
    Each PAD program should include the following major elements:
    <bullet> Support of the program by each of the facility's occupant 
agencies
    <bullet> Training and retraining personnel in CPR and the use of 
the AED and accessories
    <bullet> Obtaining medical direction and medical oversight from 
nationally recognized institutions or agencies (for example, medical 
oversight can be obtained through existing federal resources such as 
Federal Occupational Health--http://www.foh.dhhs.gov/services/AED/AED.asp)
    <bullet> Understanding legal aspects
    <bullet> Development and regular review of the PAD program and 
standard operational protocols (SOPs)
    <bullet> Development of an emergency response plan and protocols, 
including a notification system to activate responders
    <bullet> Integration with facility security and EMS systems
    <bullet> Maintaining hardware and support equipment on a regular 
basis and after each use (Note: AEDs are not building equipment and, as 
such, are not inventoried or maintained by GSA or property management 
personnel)
    <bullet> Educating all employees regarding the existence and 
activation of the PAD program
    <bullet> Development of quality assurance and data/information 
management plans
    <bullet> Development of measurable performance criteria, 
documentation and periodic program review
    <bullet> Review of new technologies
    It is important to emphasize that PAD programs are not isolated 
``one-time events.'' PAD programs should be reviewed on a regular basis 
and improved, where possible. Additionally, after every incident 
involving the use of the PAD system, a thorough post-event review of 
system performance should be undertaken.
    A key element in assuring that the PAD program will be clearly 
understood and will function well is the development of SOPs for the 
major components of the program. SOPs, as well as the program as a 
whole, should be periodically revisited and revised, where appropriate.
    6. Designing a Public Access Defibrillation Program. Given the wide 
variety of Federal work facilities, there will be significant variation 
in the complexities associated with PAD program design. Not all Federal 
facilities are appropriate for PAD programs. The decision to develop a 
PAD program for a particular Federal facility should include all major 
stakeholders in the potential PAD program, including consultation with 
a physician (consultation with a physician can be obtained through 
existing federal resources such as Federal Occupational Health--http://www.foh.dhhs.gov/services/AED/AED.asp). Facility leadership should take 
steps to assure that all stakeholders, including those who are external 
to the facility, are afforded the opportunity to participate in 
planning and design. Small, physically compact offices will require 
different levels of planning and design than large, multi-building 
facilities spread over campus environments. Although it is possible to 
have the full range of planning and design activities performed by a 
consultant or contractor, it should be kept in mind that the actual 
responders at a facility typically will be those who work there and 
that both individual

[[Page 41136]]

employees and union interests, in accordance with collective bargaining 
agreements, should be considered in any process. Officials in the 
facility's management ``chain of command'' must have close involvement 
at every step, as provided in 41 CFR 102-74.230 through 102-74.260, 
entitled ``Occupancy Emergency Program,'' for occupants of facilities 
under GSA's jurisdiction, custody or control.
    While many Federal agencies' facilities are single-tenant buildings 
or may have several tenants under the clear command or leadership of a 
ranking official, other GSA facilities contain multiple tenants that 
are not under the direction of a single agency official. For guidance 
on establishing, coordinating and implementing a comprehensive 
Occupancy Emergency Program, see 41 CFR 102-74.230 through 102-74.260, 
entitled ``Occupancy Emergency Program.'' For these purposes, the 
definition of ``emergency'' includes medical emergencies (see 41 CFR 
102-71.20). In facilities that are multi-tenant, special attention 
should be paid to avoid confusion about decision-making processes and 
authority for the development and operation of a PAD program. It is 
recommended that the Federal agencies in multi-tenant facilities follow 
the guidelines described in 41 CFR 102-74.230 through 102-74.260 to 
assure clarity of responsibility and accountability.
    We further recommend that AED response orders be included as part 
of each facility's Occupant Emergency Plan. See ATTACHMENT A, entitled 
``SAMPLE AED PROTOCOL AND RESPONSE ORDER ELEMENTS.''
    7. Selecting Your Automated External Defibrillator. Only 
commercially available AEDs that have been cleared for marketing by the 
U.S. Food and Drug Administration (FDA) should be considered for use in 
a PAD program. Prior to purchasing, it is important for facility 
leadership to seek assistance in the selection of a device for 
deployment in the facility. Because technology is developing quite 
rapidly, seeking the advice of an individual or organization with 
current knowledge about AEDs is essential. Involving a medical 
oversight provider(s) is crucial.
    All AEDs in PAD programs should be consistent with current AHA 
Guidelines for CPR and Emergency Cardiac Care. This includes the audio 
and visual commands of the AED as well as the electrocardiographic 
analysis and defibrillation algorithms.
    Additionally, as there are some differences in the devices 
currently on the market, an expert can help to explain the relative 
advantages and disadvantages of AEDs for a particular location. 
Utilizing a single brand of AED within a facility will greatly simplify 
training, maintenance and data management.
    Currently, there are Federal Acquisition Service supply contracts 
for AEDs. However, most AEDs require a prescription from a physician 
for purchase. At the present time, there is only one AED cleared for 
over-the-counter-sale. The selection of a particular AED and associated 
equipment are integral components of a PAD program and, in such a 
program, plans and protocols that are approved by a supervising 
physician are considered a prescription. Once the physician has 
approved and signed off on AED selection and placement, if required, 
this becomes the authorizing prescription for procurement of the 
device(s). An agency's procurement office can assist in locating 
current contract information and prices. The physician providing 
medical oversight for a PAD program can advise on prescription 
requirements for the AED.
    In the future, additional products are likely to receive clearance 
for marketing from the FDA. Program designers should take steps to 
confirm that all devices that are acquired have received FDA clearance 
and that the use of AEDs in their respective facilities fully complies 
with FDA labeling requirements.
    Emergency response and AED usage protocols signed by a physician 
constitute legal authorization for properly trained and certified 
individuals to use AEDs in a particular manner as outlined in the 
protocol. Responders must be familiar with and trained in the context 
of the approved procedures in the facility and strictly adhere to these 
procedures when an emergency occurs.
    The actual selection and procurement of AEDs should be one of the 
last steps in the design of a facility's PAD program and should be done 
under the guidance and written authorization of the PAD program's 
supervising physician. The protocol for AED usage that is developed as 
part of a facility's PAD program is an integral part of the physician's 
medical oversight and serves as the authorizing document for AED use. 
Protocols should be reassessed periodically in accordance with a 
regular schedule of reviews as determined in consultation with the 
PAD's supervising physician. A current protocol that takes into 
consideration both new treatment recommendations and any changes in the 
FDA labeling of the AED should be integrated into the PAD training and 
education and re-training programs.
    Essentially, the protocols that are signed by the supervising 
physician set the medical standards and criteria for the operation of 
the PAD program and all of its components. Systems operated within the 
boundaries and criteria of these signed protocols are considered to be 
under a physician's supervision, whether or not the physician is 
physically present in the facility. As noted in this guidance, PAD 
programs should be reviewed on a regular basis (after each activation 
and on a regular basis) with changes made, as needed, under the 
direction of the supervising physician. Revised protocols should be in 
accordance with current AHA Guidelines for CPR and Emergency 
Cardiovascular Care.
    8. Medical Oversight of a Public Access Defibrillation Program. 
AEDs are medical devices that are to be used under the advice and 
consent of a physician only by individuals with the proper training and 
certification. Therefore, medical oversight is an essential component 
of PAD programs. This oversight can be provided either by a facility's 
own physician, through existing federal resources (including Federal 
Occupational Health--http://www.foh.dhhs.gov/services/AED/AED.asp) or 
by a contracting physician, in accordance with applicable federal, 
state and local laws. It is best to seek medical input from the very 
beginning of the program. A physician should be involved as a 
consultant in all aspects of the program.
    Medical and physician oversight does not mean that a physician is 
required to be present to manage the PAD program on a day-to-day basis. 
However, it is prudent for facility leadership to develop management 
and oversight protocols of lay program overseers so that quality is 
consistently maintained. Additionally, a central role for the physician 
is conducting assessment of the PAD system's performance after the use 
of an AED, including review of the AED data and the electrocardiograph 
tracing of a victim.
    9. Legal Issues. Any PAD program should be reviewed by agency legal 
counsel, so that the program, as designed, is in compliance with all 
applicable federal, state and local laws. PAD programs establish 
procedures for dealing with emergent medical situations that present an 
appreciable risk of serious bodily injury and death regardless of the 
degree of care exercised by those involved in responding to the 
situation. These situations are often the subject of regulation by 
various authorities. The

[[Page 41137]]

risk of liability for failing to comport with applicable regulations, 
and for acts or omissions that result in harm, are important and ever-
present concerns that should be addressed in the PAD program. Though 
federally owned facilities generally are not subject to state and local 
authority, federal law can incorporate or adopt specific state and 
local authorities or otherwise make them applicable to federal 
facilities.
    One of the most important legal concerns with any PAD program will 
be the potential liability of those who respond to the emergent 
situation, including, potentially, Federal employees. The following 
legal principles should be considered in developing a PAD program:
    <bullet> As a general rule, the Federal Tort Claims Act, 28 U.S.C. 
1346(b), 2401(b), 2671-80 (FTCA), immunizes Federal employees acting 
within the scope of their employment from personal liability for most 
tortious conduct. Whether an individual Federal employee is acting 
within the scope of his or her employment is, under the FTCA, 
determined by the substantive law of the state where the act or 
omission occurred. Employees whose use of an AED is outside the scope 
of employment may not be entitled to either immunity from liability 
under the FTCA or representation by the Department of Justice, in the 
event suit is filed challenging their conduct in operating an AED 
system. However, other immunity provisions may apply as discussed 
below.
    <bullet> The liability of the Federal Government for injuries 
caused by Federal employees acting within the scope of their employment 
also is determined by the FTCA. The FTCA provides that liability is 
determined according to the law of the place where the wrongful or 
negligent act or omission occurred. Under the FTCA, the Federal 
Government is not liable for the wrongful acts of any person who is not 
a ``Federal employee'' as defined in 28 U.S.C. 2671.
    <bullet> Under the FTCA, the United States is subject to liability 
for the negligence of an independent contractor only if it can be shown 
that the government had authority to control the detailed physical 
performance and exercised substantial supervision over the day-to-day 
operations of the contractor. Thus, a PAD program should consider 
placing responsibility for responding to emergency medical situations 
on a contractor over whom the Federal Government does not exercise day-
to-day control. The PAD program should, however, include criteria to 
assure that the contractor has the requisite expertise, training and 
resources.
    <bullet> Many states have enacted legislation to provide some 
degree of immunity to lay individuals who provide assistance to people 
in distress. The laws are called ``Good Samaritan'' laws. Since these 
laws vary from state to state, management of individual facilities 
should be aware of the law applicable to their facility.
    <bullet> Congress provided additional protection from civil 
liability for AED use in the Public Health Improvement Act, Public Law 
106-505 (November 13, 2000). Subtitle A of Title IV of the Public 
Health Improvement Act, referred to as the Cardiac Arrest Survival Act 
of 2000, provides persons who use or attempt to use an AED, and persons 
who acquire an AED, immunity from civil liability for harms resulting 
from the use or attempted use of the AED, subject to a number of 
important exceptions. The statute provides default immunity only. The 
federal immunity supersedes state law only to the extent that a state 
has no statute or regulation that provides users or acquirers with 
immunity for civil liability arising from the use of an AED in an 
emergency situation. The statute explicitly states that its provisions 
are not intended to waive any protections from liability for Federal 
officers and employees provided in the FTCA or the Westfall Act. 
Nothing in these guidelines or in any PAD program established pursuant 
to these guidelines should be read as creating a duty for Federal 
employees or contractors not otherwise existing under applicable state 
or Federal law to provide assistance to persons in medical distress.
    10. Lay Responder and Rescuer Training. Even in the case where 
large facilities have self-contained emergency medical services 
systems, it is still advisable to devise a training program for LRRs. 
The greater the number of well trained LRRs that are available, the 
more effective a PAD program will be. Overall effectiveness will be 
improved as the number of personnel who are fully trained and willing 
to respond increases. As a general matter, in facilities where there 
are sufficient numbers of personnel to permit in-house training 
programs, a routine training schedule should be established. An 
additional benefit of in-house training is that training in groups that 
correspond closely with work groups tends to build a better sense of 
team and responsibility than would individual, separate training.
    Nationally recognized training organizations, such as AHA, ARC and 
NSC, provide materials and guidance through a variety of courses that 
include combined CPR and AED training. These programs provide 
comprehensive materials for the training of LRRs and are targeted 
toward providing lay persons all of the information and training 
necessary to assess the status of a victim competently, administer CPR, 
if necessary, and to operate an AED properly. Some PAD programs may 
require additional training in pediatric CPR, if there are children in 
the facility, i.e., a daycare facility. It is important for LRRs to be 
trained in the maintenance and operation of the specific AED model that 
will be used in their PAD program.
    Although universal precautions are taught in CPR and AED classes, 
additional bloodborne pathogen training is highly recommended for LRRs. 
Federal agencies utilizing LRRs should develop an ``Exposure Control 
Plan for Bloodborne Pathogens,'' which may be incorporated into the 
Occupancy Emergency Program for the facility.
    Agencies should organize their responses around a team approach 
using either LRRs or existing emergency response resources, such as 
security.
    All PAD training programs should include a component that describes 
and explains the facility specific program. All retraining or refresher 
programs should, likewise, include this component to assure that LRRs 
are aware of the most current information regarding their specific PAD 
program.
    Training is not a one-time event. Leadership should seek to 
maintain and improve the LRRs' skills and abilities. Formal CPR and AED 
training should be conducted at the frequency as recommended by the 
nationally recognized training organization used by the agency, but at 
least every two years. Mock drills and refresher sessions engage teams 
in periodic ``scenario'' practice sessions to maintain LRRs skills and 
rehearse protocols. Computer-based programs, video teaching materials 
and AED trainer devices permit more frequent review of basic CPR and 
AED skills. Mock drills and refresher practice sessions will be 
important to maintain current knowledge and a reasonable comfort level 
among LRRs and response teams. Mock drills are recommended on an annual 
basis and the mock drill results should be reviewed by the program's 
medical director. The frequency of sessions will vary from facility to 
facility. Refresher sessions should be held at least every six months 
and established in consultation with the physician providing medical 
oversight.
    11. Placement of and Access to Automated External Defibrillators. 
While there is no single ``formula'' to determine the appropriate 
number,

[[Page 41138]]

placement, and access system for AEDs, there are several major elements 
that should be considered. However, all considerations are based upon 
(1) an optimal response time of 3 minutes or less and (2) an assessment 
of the level of risk in a facility's environment. Factors that should 
be considered include:
    <bullet> Response Time: The optimal response time is 3 minutes or 
less. This interval begins from the moment a person is identified as 
needing emergency care to when the AED is at the side of the victim. 
Survival rates decrease by 7 to 10 percent for every minute that 
defibrillation is delayed. Therefore, it is recommended that Federal 
agencies train as many employees as possible on the use of AEDs.
    <bullet> Demographics of the Facility's Workforce: Leadership 
should examine the composition of the resident workforce. Since the 
likelihood of an event occurring increases with age, special 
consideration should be given to the age profile of the workforce.
    <bullet> Visitors: Facilities (including Federal areas, such as 
Wilderness Areas and National Parks) that host large numbers of 
visitors are more likely to experience an event, and an appraisal of 
the demographics of visitors should be included in an assessment.
    <bullet> Specialty Areas: Facilities where strenuous work is 
conducted are more likely to experience an event. Additionally, 
specialty areas within facilities, such as exercise and work out rooms, 
should be considered to have a higher risk of an event than areas where 
there is minimal physical activity.
    <bullet> Physical Layout of Facility: Response time should be 
calculated based upon how long it will take an LRR with an AED walking 
at a rapid pace to reach a victim. Large facilities and buildings with 
unusual designs, elevators, campuses with several separate buildings, 
and physical impediments all present unique challenges to LRRs. In some 
larger facilities, it may be necessary to incorporate the use of 
properly equipped ``golf cart'' style conveyances to accommodate time 
and distance conditions.
    <bullet> Physical Placement of AEDs: Facilities that have large 
open areas present unique challenges.
    <bullet> GSA should be notified of any alterations necessary to 
accommodate the placement of AEDs in GSA-controlled facilities.
    12. Characteristics of Proper Automated External Defibrillator 
Placement. There are several elements that contribute to the proper 
placement of AEDs. The major elements are:
    <bullet> An easily accessible position (e.g., placed at a height so 
those shorter individuals can reach and remove the device, unobstructed 
access).
    <bullet> A secure location that prevents or minimizes the potential 
for tampering, theft or misuse, and precludes access by unauthorized 
users. Facilities should take additional steps to assure that an AED 
has not been stolen or improperly removed.
    <bullet> A location that is well marked, publicized and known among 
trained staff. Periodic ``tours'' of locations are recommended.
    <bullet> A nearby telephone that can be used to call backup, 
security, EMS, or 911 to be sure that additional help is dispatched.
    <bullet> Protocols should clearly address procedures for activating 
local EMS personnel. These protocols should include notification of EMS 
personnel of the quantity, brands and locations of AEDs within the 
facility. This information will enhance dispatch and the EMS responder 
protocol, enabling proper planning and scene management once EMS 
personnel arrive at the victim's side. Equipment stored in a manner in 
which the removal of the AED automatically notifies security, EMS or a 
central control center is ideal.
    <bullet> Where automatic notification of the opening of an AED 
storage cabinet or removal of an AED from a cabinet is not implemented, 
emphasis should be placed on notification procedures and equipment 
placement in close proximity to a telephone.

Equipment To Be Placed With AEDs

    It is recommended that additional items that may be necessary to a 
successful rescue be placed in a bag and stored and accessible with the 
AED. Keep in mind that CPR is an essential element of an effective 
rescue and that, as a victim collapses, other physical injury may occur 
concurrently:
    <bullet> A set of simplified directions for CPR and the use of the 
AED
    <bullet> Non-latex protective gloves (several pairs in small, 
medium and large sizes)
    <bullet> Appropriate sizes of CPR face masks with detachable 
mouthpieces, plastic or silicone face shields (preferably clear), with 
one-way valves, or other type of barrier device that can be used in 
mouth to mouth resuscitation
    <bullet> Disposable razor to dry shave a victim in chest areas, if 
needed, as well as a supply of 4x4 gauze pads to clear and dry an area, 
to assure proper electrode-to-skin contact
    <bullet> A pair of medium size bandage or blunt end scissors
    <bullet> Spare battery and electrode pads
    <bullet> Two biohazard or medical waste plastic bags for waste or 
for transport of the AED should it become contaminated
    <bullet> Pad of paper and writing tools
    <bullet> One absorbent towel
    In large or complex facilities, access routes should be given 
careful consideration. Such facilities may demand the use of a 
designated responder or team approach, in which at least one responder 
has keys or passes to allow for the use of a more direct route or 
elevator override key to expedite access and transport by appropriate 
medical or EMS personnel.
    13. Follow-up After an Automated External Defibrillator Is Used. 
All AEDs are equipped with a credit card size device (i.e., data card), 
or have the capacity to internally store data for later downloading, 
that will record and contain information about the patient's heart 
rhythm, AED assessment functioning, and the characteristics of the 
shock(s) administered. Depending on the design of a particular PAD, the 
AED will either accompany the victim to the hospital or will be 
retained on site for the medical advisor as part of the PAD's program 
review. The proper disposition of the AED and its electronic recorder 
module must be addressed in a PAD program's protocols.
    After an event, the PAD medical director should be promptly 
notified, and a review and assessment of performance should be 
performed. This process is best led by the PAD's physician overseer. A 
copy of the full report should be provided to and reviewed by the 
Designated Official and any other authorities, as required by 
applicable state and local laws.
    Incident reports and follow-up should be performed as soon as 
possible, and restocking of supplies and returning the AED to service 
should be accomplished promptly. All aspects of the performance of the 
system, people, device, and protocols should be addressed in a non-
judgmental manner with an eye toward verifying or improving 
effectiveness and to identify problem areas that must be resolved. 
Responsibility for each step should be clearly articulated in 
protocols. The results of routinely scheduled and post-event reviews 
should be shared and discussed with facility management and other 
interested parties, as deemed appropriate in a particular facility. 
Individuals with responsibility for facility oversight are also 
responsible for the PAD program and should remain informed about their 
program's performance.
    Post-event reviews should be arranged and conducted with 
sensitivity to issues

[[Page 41139]]

of medical and patient record confidentiality. As such, the physician 
overseeing the PAD program should conduct a thorough medical 
documentation review prior to the ``process'' evaluation that will be 
conducted by or for individuals with responsibility for facility 
management. The physician should be responsible for assuring that 
privileged or confidential patient information is shielded.
    An essential post-event consideration is the psychological effect 
on LRRs and others. It is not at all uncommon for LRRs, witnesses and 
co-workers to have psychological or stress reactions to an event. These 
people may have both emotional and physical reactions that need to be 
addressed, but for which there is a reluctance to come forward to ask 
for help. Facility leadership has a positive obligation to reach out 
and offer help to these individuals, affirming that such responses are 
normal and to a large extent to be expected. Post-event support is 
especially important in cases where a rescue is unsuccessful. Post-
event support should be available and offered promptly after an event, 
and the invitation to seek assistance should remain open. This type of 
psychological care is best provided by trained professionals with 
expertise in the area of critical incident stress management. Provision 
of these psychological services should be addressed in the PAD program 
design and protocols.

Attachment A

Sample AED Protocol and Response Order Elements

Activation of the Automated External Defibrillator Response Team
    1. During Health Unit Duty Hours: 7 a.m. to 12 a.m. Monday through 
Friday; weekends and Federal holidays, the Health Unit is closed. In 
any potentially life-threatening cardiac emergency:
    (a) The first person on the scene will:
    (i) Call the Security Console by dialing ``0000'' and inform them 
of the location and nature of the emergency.
    (ii) Remain with the victim, send a co-worker to meet the emergency 
team at a visible location and escort to the site.
    (iii) Initiate CPR.
    (b) Security Personnel immediately upon receiving the call will:
    (i) Notify the AED response team by dialing the group notification 
number for the AED team pagers and enter the code for the location of 
the emergency.
    (ii) Notify local EMS 911.
    (iii) Inform the EMS operator of location and nature of emergency 
and that an AED unit is on site.
    (iv) Notify Federal Police Officer(s) to meet the EMS personnel and 
escort them to the site of the emergency.
    (v) Notify Federal Police Officer(s) to respond to the site and 
offer any assistance needed (if staffing allows).
    (c) Health Unit staff immediately upon receiving the notification 
will proceed directly to the scene with the Health Unit AED and other 
emergency equipment (2 nurses will respond, if available).
    (d) Other AED responders immediately upon receiving the 
notification will:
    (i) (The team member previously designated to transport the AED 
unit) obtain the AED unit closest to them or to the site of the 
emergency and proceed with it to the emergency site.
    (ii) (All other AED responders) go directly to the site of the 
emergency.
Emergency Site Protocol
    --Whichever AED responder arrives on the scene first will assess 
the victim. If AED use is indicated, the AED trained personnel will 
administer the AED and assist with CPR according to established 
protocols (see AED Treatment Algorithm).
    --When the Health Unit Nurse is on the scene, he or she shall be in 
charge of directing the activities until the local EMS arrives and 
assumes care of the victim.
    --Any additional AED responders shall assist with CPR, recording of 
data and time, notifications, crowd control, and escorting of EMS, as 
needed. Any additional AED units will remain on site as a back-up.
    2. Non-Health Unit Hours: 12 a.m. to 7 a.m. Monday through Friday, 
and All Hours Saturday, Sunday and Federal holidays. In any potentially 
life-threatening cardiac emergency:
    (a) The first person on the scene will:
    (i) Call the Security Console by dialing ``0000'' and inform them 
of the location and nature of the emergency.
    (ii) Remain with the victim, send a co-worker to meet the emergency 
team at a visible location and escort to the site.
    (iii) Initiate CPR.
    (b) Security Personnel immediately upon receiving the call will:
    (i) Notify the AED response team by dialing the group notification 
number for the AED team pagers and enter the code for the location of 
the emergency.
    (ii) Notify local EMS 911.
    (iii) Notify Federal Police Officer(s) to meet the EMS personnel 
and escort them to the site of the emergency.
    (iv) Notify Federal Police Officer(s) to respond to the site and 
offer any assistance needed (if staffing allows).
    (c) AED Responders immediately upon receiving the notification 
will:
    (i) (The team member previously designated to transport the AED 
unit) obtain the AED unit closest to them or to the site of the 
emergency and proceed with it to the emergency site.
    (ii) (All other AED responders) go directly to the site of the 
emergency.
    (iii) (Whichever AED responder arrives on the scene first) assess 
the victim. If AED use is indicated, the AED trained personnel will 
administer the AED and assist with CPR according to established 
protocols (see AED Treatment Algorithm) until local EMS professionals 
arrive and assume care of the victim.

[FR Doc. E9-19555 Filed 8-13-09; 8:45 am]
BILLING CODE P


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