[Federal Register Volume 66, Number 100 (Wednesday, May 23, 2001)]
[Notices]
[Pages 28495-28511]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 01-12939]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

GENERAL SERVICES ADMINISTRATION


Guidelines for Public Access Defibrillation Programs in Federal 
Facilities

AGENCY: Office of Public Health and Science, Office of the Secretary, 
HHS and Office of Governmentwide Policy, GSA.

ACTION: Notice of availability of guidelines.

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SUMMARY: The Department of Health and Human Services (HHS) and the 
General Services Administration (GSA) have worked collaboratively to 
develop the following guidelines, entitled ``Guidelines for Public 
Access Defibrillation Programs in Federal Facilities.'' Theses 
guidelines were prepared, in part, in response to a May 19, 2000, 
Presidential Memorandum pertaining to the establishment of guidelines 
for the placement of automated external defibrillators (AEDs) in 
Federal buildings.
    In addition, the Department of Health and Human Services is 
publishing this notice pursuant to section 7 of the Healthcare Research 
and Quality Act of 1999, Public Law 106-129, 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, Public Law 106-
505).
    The guidelines provide a general framework for initiating a design 
process for public access defibrillation (PAD) programs in Federal 
facilities and provide basic information to familiarize facilities 
leadership with the essential elements of a PAD program. The guidelines 
are not intended to 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.

FOR FURTHER INFORMATION CONTACT: Stanley C. Langfeld, Director, Real 
Property Policy Division (MPR), Room 6210, General Services 
Administration,

[[Page 28496]]

1800 F Street, NW., Washington, DC 20405, telephone 202-501-1737. 
Arrangements to receive the policy guidelines in alternative format may 
be made by contacting the named individual.

    Dated: May 15, 2001.
G. Martin Wagner,
Associate Administrator for Governmentwide Policy, General Services 
Administration.
Arthur J. Lawrence,
Assistant Surgeon General, Acting Principal Deputy Assistant Secretary 
for Health, Department of Health and Human Services.

Attachment--Guidelines for Public Access Defibrillation Programs in 
Federal Facilities, January 18, 2001

                            Table of Contents
------------------------------------------------------------------------
                  Section                           Section title
------------------------------------------------------------------------
1.0.......................................  Purpose.
2.0.......................................  General.
3.0.......................................  The Concept of Public Access
                                             Defibrillation (PAD).
4.0.......................................  Establishing a PAD Program
                                             in a Federal Facility.
5.0.......................................  Designing a PAD Program.
6.0.......................................  Selecting Your AEDs.
7.0.......................................  Medical Oversight of Your
                                             PAD Program.
8.0.......................................  Legal Issues.
9.0.......................................  Lay Responder/Rescuer (LRR)
                                             Training.
10.0......................................  Placement of and Access to
                                             AEDs.
11.0......................................  Characteristics of Proper
                                             AED Placement.
12.0......................................  Follow-Up After an AED is
                                             Used.
Attachment A..............................  Sample AED Protocol And
                                             Response Order Elements.
Attachment B..............................  Draft Summary Of Legislative
                                             Activity By State As of
                                             June 1, 2000.
------------------------------------------------------------------------

1.0  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 in any Federal facility will be 
unique, and depend on many factors, including the population 
demographics of the facility/Federal area, and size and location of the 
facility/Federal area. The design process and key elements of a PAD 
program cited 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 PAD programs. 
Rather, it is aimed at providing 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 planning. The required medical consultation can 
be obtained from Federal sources or private contractors.

2.0  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 life-saving devices.
    Ventricular fibrillation (VF) is a common arrhythmia leading to 
cardiac arrest and death. VF is unorganized electrical activity of the 
heart, resulting in producing no blood flow or pulse and which 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 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 directly tied 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 utilized 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 fully recover. As 
the length of time between the onset of sudden cardiac arrest 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. The importance of rapid and positive 
intervention is reflected in the American Heart Association's 
(AHA)``Chain of Survival'' concept.
    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 ``Chain of Survival'' is designed to optimize a patient's 
chance for survival of sudden cardiac arrest. There are four links in 
the chain: early access, early cardiopulmonary resuscitation (CPR), 
early defibrillation, and early advanced cardiac life support (ACLS).
    Early access means that members of the community have been trained 
to quickly recognize possible cardiac arrest and that a mechanism for 
immediate communication of the event and activation of an EMS response 
is in place to assure that fully trained EMS personnel and equipment 
can arrive quickly at the scene. Early CPR by bystanders provides 
ventilation and circulation, ``buying'' precious minutes for EMS teams 
to arrive with a full set of ACLS equipment. The core concept of the 
PAD strategy is to initiate CPR promptly and bring the defibrillator 
and a trained LayResponder/Rescuer (LRR) into the incident sooner than 
a fully equipped EMS unit can be on location.
    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 and/or changes in recommendations.
    Special Note: As is the case in 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,

[[Page 28497]]

as well as the technology of AEDs themselves, is evolving.
    For Federal agencies in GSA controlled space, the Designated 
Official should take reasonable steps to assure that a program's 
supervising physician reviews the facility's program on a regular basis 
in light of the most current scientific literature. 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 41 CFR 101-20.003(g)). AED 
programs should evolve based on the best available science to assure 
the most efficient use of resources and the best outcomes possible. 
Federal sites implementing AED programs should strongly consider 
coordinating with, and becoming a component of, organized research or 
evaluation efforts in their communities. Assistance in determining if a 
facility is eligible to participate in such an effort can be obtained 
through the National Heart, Lung, and Blood Institute, AHA, American 
College of Emergency Medicine (ACEM) or the nearest research 
university/academic health center.

3.0  The Concept of Public Access Defibrillation (PAD)

    Traditionally, EMS systems employ paramedic and emergency medical 
technician (EMT)--level personnel in conjunction with some level of 
involvement by community members, predominantly bystanders who are CPR 
trained. Most communities provide CPR training opportunities either 
through a local institution or via programs sponsored by units of a 
local or State/Territorial government. Until recently, AEDs and other 
defibrillation devices have been brought to locations by the local EMS 
system. The size, cost, and complexity of these devices, as well as 
other factors, have constrained 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 sudden cardiac arrest 
that occurs in a non-medical setting may require a program that 
utilizes community ``volunteer'' lay responders or rescuers (non-
medical 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 the community (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 and who have 
been certified by a competent authority. Persons without these basic 
credentials should not use the device.

4.0  Establishing a PAD Program in a Federal Facility

    Before establishing a program in a 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 effective and successful will be 
the program.
    Each PAD program should include the following major elements:
     Support of the Program by Agency Leadership
     Training/Certifying and Retraining Personnel in 
CardiopulmonaryResuscitation (CPR) and the Use of the AED and 
Accessories
     Obtaining Medical Direction and Medical Oversight
     Understanding Legal Aspects
     Development and Regular Review of PAD and Operational 
Protocols
     Development of an Emergency Response Plan and Protocols, 
Including a Notification System to Activate Responders
     Integration with Facility Security and Emergency Medical 
Services (EMS) Systems
     Maintaining Hardware and Support Equipment on a Regular 
Basis and After Each Use
     Development of Quality Assurance and Data/Information 
Management Plans
     Development of Measurable Performance Criteria, 
Documentation and Periodic Program Review
     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 use of the PAD system, a thorough post-event review of system 
performance should be undertaken. The skills of personnel who are 
potential responders and rescuers should be refreshed and new personnel 
trained. The program should make an effort to routinely and regularly 
assess the operating state and condition of AED and support equipment 
as well.
    A key element in assuring that your PAD program will be clearly 
understood and will function well is the development of standard 
operating procedures (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.

5.0  Designing a PAD Program

    Given the wide variation in Federal work facilities, there will be 
significant variation in the complexities associated with program 
design. Small, physically compact offices will require different levels 
of planning and design than large, multi-building facilities spread 
over campus environments. 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. Although it is possible to have the full range of planning and 
design activities performed via consultant or contract, it should be 
kept in mind that the actual responders at a facility typically will be 
those who work there and that both individual employees'' and unions'' 
interests, in accordance with union contracts, should be considered in 
any process. Officials in the facility's management ``chain of 
command'' must have close involvement at every step, as specified for 
occupants of facilities under GSA custody and control in 41 CFR 101-
20.103-4, entitled ``Occupancy Emergency Program.''
    While most Federal agencies' facilities are single tenant buildings 
or may have several tenants under the clear command/leadership of a 
ranking official, many GSA facilities contain multiple tenants that are 
not under the direction of a single agency official. 41 CFR 101-20.103, 
entitled ``Physical protection and building security,'' provides 
guidance on coordinating and implementing a comprehensive 
OccupancyEmergency Program. (The definition of ``emergency'' in this 
part

[[Page 28498]]

(see 41 CFR 101-20.003(i)) includes medical emergencies.) 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 circumstances follow the guidelines 
described in 41CFR 101-20.103 to assure clarity of responsibility and 
accountability.
    Because Federal law enforcement officers routinely respond to 
emergencies within Federal properties and are familiar with all sites 
within their jurisdiction and are required to be first aid and CPR 
trained, it is recommended that all Federal Police Officers also 
receive the necessary training in the use of AEDs. Federal agencies 
should also consider the security implications of training contract 
guards in the use of AEDs since these guards have responsibilities to 
guard entry points and other fixed posts within a facility. The 
security implications of contract guards abandoning these posts during 
a medical emergency should be carefully considered in the development 
and operation of a PAD program.
    We recommend that Automated External Defibrillator response orders 
be included as part of each facility's Occupant Emergency Plan. See 
ATTACHMENT A, entitled ``SAMPLE AED PROTOCOL AND RESPONSE ORDER 
ELEMENTS.''

6.0  Selecting Your AEDs

    Only commercially available AEDs that have been cleared for 
marketing by the 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.
    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 your particular location. 
Utilizing a single brand of AED within a facility will greatly simplify 
training, maintenance, and data management. It would be wise to contact 
local EMS personnel to seek their opinion and to clarify protocols with 
respect to equipment use.
    Currently, there are Federal Supply Service (FSS) Supply contracts 
for AEDs. A prescription from a physician overseeing the AED placement 
must accompany the order before the AED manufacturer can accept the 
order and deliver the AED. Your procurement office can assist in 
locating current contract information and prices.
    In the future, additional products are likely to receive approval 
for marketing from the FDA. Program designers should take steps to 
confirm that all devices that are acquired have received FDA marketing 
approval and that the use of AEDs in their respective facilities fully 
complies with FDA labeling requirements.


    Special Note: AEDs are prescription devices. In a PAD program, 
plans and protocols that are approved by a supervising physician are 
considered a prescription. The selection of a particular AED and 
associated equipment are integral components of a PAD program. Once 
the physician has approved and signed-off on AED selection and 
placement, this becomes the authorizing prescription for procurement 
of the device(s).


    Emergency response and AED usage protocols that are signed by a 
physician are a prescription constituting legal ``permission'' 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 
prescription and serves as the authorizing document for AED use. 
Protocols should be periodically reassessed 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/or on a regular basis) with changes made as needed under the 
direction of the supervising physician. These revised or re-certified 
protocols constitute new or renewed prescriptions.

7.0  Medical Oversight of Your PAD 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 medical staff, such as a Health Unit, or contractor or through an 
agency-wide designated Federal physician in accordance with state and 
local laws. It is best to seek medical input from the very beginning of 
the design of your program. A physician should be involved as a 
consultant in all aspects of the program, not only as the program's 
prescribing physician, but also as an active participant in all 
aspects.
    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 to assure that quality 
is consistently maintained. Physicians can be extremely helpful in 
assisting facility leadership in linking their PAD program with the 
community at large and with appropriate EMS and hospital systems. 
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.

8.0  Legal Issues

    Any PAD program should be reviewed by legal counsel to assure that 
the program, as designed, comports with all applicable Federal, State 
and local authorities. 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 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 federal facilities

[[Page 28499]]

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 
principles should be considered in developing a PAD program:
     As a general rule, the Federal Tort Claims Act, 28 U.S.C. 
sections 1346(b), 2671-80, (FTCA) immunizes Federal employees acting 
within the scope of the employment from personal liability for most 
tortious conduct. Whether an individual Federal employee was acting 
within or without of the scope of his/her employ 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 their employment may be eligible for federal representation, but 
could be personally liable for any harm that results from the use of 
the AED.
     The liability of the Federal government for injuries 
caused by Federal employees acting within the scope of their employment 
is determined by the FTCA as well. 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,'' defined in 28 U.S.C. section 2671.
     Under the FTCA, the United States is not liable for the 
wrongful acts of government contractors. Thus, a PAD program should 
consider reposing responsibility for responding to emergency medical 
situations on a contractor over which we do not exercise day-to-day 
control. ThePAD program should, however, include criteria to assure 
that the contractor has the requisite expertise, training and 
resources.
     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. Because these 
laws vary from state to state, management of individual facilities 
should be aware of the law applicable to them. Attachment B (entitled 
``Draft Summary of Legislative Activity by State as of June 1, 2000'') 
is a recent abstract of state/territorial ``Good Samaritan'' laws.
     Congress recently 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 
Act, 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 a default immunity only, however: the federal immunity 
displaces a State rule of decision only to the extent that State has no 
statute or regulations that provide users or acquirers with immunity 
for civil liability arising from emergent use of an AED. 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 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.

9.0  Lay Responder/Rescuer (LRR) 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 the 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 competently assess the status of a victim, administer CPR 
if necessary, and to properly operate an AED. It is important for LRRs 
to be trained on the maintenance and operation of the specific AED 
model that will be used in their PAD program.
    Some locales may wish to take an additional step and organize their 
responses around a team approach. The recommended training course 
provides flexible training and will incorporate elements of 2-person 
rescue techniques that accommodate a ``response team'' approach.
    All PAD training programs should include a component that descibes 
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 refresher 
training should be conducted at least every two years. Computer-based 
programs and video teaching materials permit more frequent review. 
Facility leadership should make periodic contact with the AHA to assure 
that advances in techniques and care are incorporated into their PAD 
program, and training in them is promptly made available to LRRs. It is 
recommended that LRR teams engage in periodic ``scenario'' practice 
sessions to maintain their skills and rehearse protocols.
    Facility leadership is urged to develop a vigorous approach to 
maintaining and improving skills. Thus, aside from formal annual re-
certification, mock drills and practice sessions will be important to 
maintain current knowledge and a reasonable comfort level among LRRs 
and/or teams. The frequency of such sessions will vary from facility to 
facility. Organizations currently operating PAD programs routinely 
complete practice sessions on a monthly to quarterly schedule. The 
intervals for conducting these exercises should be established in 
consultation with the physician providing medical oversight.

10.0  Placement of and Access to AEDs

    While there is no single ``formula'' to determine the appropriate 
number, 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) 
assessing the level of risk in a facility's environment. Factors that 
should be considered include:
     Response Time: The optimal response time is 3 minutes or 
less. This interval begins from the moment a

[[Page 28500]]

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.
     Demographics of the Facility's Workforce: Leadership 
should examine the make up of the resident workforce. Because the 
likelihood of an event occurring increases with age, consideration 
should be given to the age profile of the workforce.
     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.
     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.
     Physical Layout of Facility: Response time should be 
calculated based upon how long it will take for 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.
     Physical Placement of AEDs: Facilities that have large 
open areas present unique challenges.

11.0  Characteristics of Proper AED Placement

    There are several elements that contribute to proper placement of 
AEDs. The major elements are:
     An easily accessible position (e.g., placed at a height so 
those shorter individuals can reach and remove, unobstructed access, 
etc.)
     A secure location that prevents or minimizes the potential 
for tampering, theft, and/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.
     A location that is well marked, publicized, and known 
among trained staff. Periodic ``tours'' of locations are recommended.
     A nearby telephone that can be used to call backup, 
security, EMS, or 911 to be sure that additional help is dispatched.
     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.
     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 into a bag and be 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:
     A set of simplified directions for CPR and the use of the 
AED
     Non-latex protective gloves (several pairs in small, 
medium, and large sizes)
     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
     Disposable razor to dry shave a victim in chest areas if 
needed, as well as a supply of 4x4 gauze pads to clear/dry an area, to 
assure proper electrode-to-skin contact
     A pair of medium size bandage or blunt end scissors
     Spare battery and electrode pads
     Two biohazard or medical waste plastic bags for waste or 
for transport of the AED should it become contaminated
     Pad of paper and writing tools
     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 or elevator 
override key to expedite access and transport by appropriate medical or 
EMS personnel.

12.0  Follow-Up After an AED Is Used

    All AEDs are equipped with a credit card size device (e.g., 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 of the 
PAD's 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 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. 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 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 charged 
with 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

[[Page 28501]]

psychological or stress reactions to an event. These people may have 
both emotional and physical reactions that need to be tended to, but 
for which there is a reluctance to come forward to ask for help. 
Facility leadership has a positive obligation to pro-actively reach out 
and offer help, 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 AED Response Team

    1. During Health Unit Duty Hours: 7 a.m. to 12 a.m. Monday through 
Friday; weekends and Federal holidays, the health center 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.
    (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; 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 CPR according to established protocols (see 
Automated External Defibrillation Treatment Algorithm).
--When the Health Unit Nurse is on the scene, he/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, 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 and 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'' 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.
    (e) 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, 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 CPR according to established protocols (see 
Automated External Defibrillation Treatment Algorithm) until local EMS 
professionals arrive and assume care of the victim.

Attachment B

Draft Summary of Legislative Activity by State as of June 1, 2000

47 States Provide Limited Immunity for Lay Responders
 1. Alabama--6/99
 2. Alaska--4/98
 3. Arizona--5/99
 4. Arkansas--2/99
 5. California--7/99
 6. Colorado--3/99
 7. Connecticut--10/98
 8. Florida--4/97
 9. Georgia--3/98
10. Hawaii--5/98
11. Idaho--3/99
12. Illinois--8/99
13. Indiana--2/99
14. Iowa--2/98--*Administrative rules or regulations allow AED use by 
laymen and provide immunity
15. Kansas--3/98
16. Kentucky--2/2000
17. Louisiana--6/99
18. Maryland--4/99
19. Massachusetts--11/99* strengthened 5/98 law
20. Minnesota--3/98
21. Michigan--11/99
22. Mississippi--3/99
23. Missouri--3/98
24. Montana--4/99
25. Nebraska--4/99
26. Nevada--6/97
27. New Hampshire--7/99
28. New Jersey--3/99
29. New Mexico--4/99
30. New York--8/98
31. North Dakota--3/99
32. Ohio--11/98
33. Oklahoma--4/99
34. Oregon--6/99
35. Pennsylvania--12/98
36. Rhode Island--95
37. South Dakota--2/00
38. South Carolina--6/99
39. Tennessee--5/99* strengthened 5/98 law
40. Texas--6/99
41. Utah--3/99
42. Vermont--5/00
43. Virginia--3/99
44. Washington--6/98
45. Wisconsin--7/99
46. West Virginia--3/99
47. Wyoming--3/99

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[FR Doc. 01-12939 Filed 5-22-01; 8:45 am]
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