Guidelines for Public Access Defibrillation Programs in Federal Facilities

05/23/2001

Federal Register

Page 28495

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 Number 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,

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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

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(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

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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

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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 Number 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).

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).

(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

Public Access Defibrillators - Draft Summary of Legislative Activity by

State as of June 1, 2000 on Pages 28502-28511 of Original Document.

[FR Doc. 01-12939 Filed 5-22-01; 8:45 am] BILLING CODE 6820-23-C