Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 28495

DATES: The Commercial Activities Panel

will hold a public hearing on June 11,

2001, beginning at 9:00 a.m. in the

Walsh-Reckord Hall of States at One

Massachusetts Avenue, Washington,

DC. Individuals or groups that wish to

attend or participate in the hearing

should notify the Panel and submit

written summaries of their statements

by June 4, 2001.

ADDRESSES: Submit requests to attend or

participate in the hearing, written

summaries of oral statements, and any

other relevant materials via E-mail to

A76panel@gao.gov or to the General

Accounting Office, Office of the General

Counsel, Room 7476, 441 G St., NW,

Washington, DC 20548. See

SUPPLEMENTARY INFORMATION for other

information about electronic filing.

FOR FURTHER INFORMATION CONTACT:

William T. Woods, Project Director,

(202) 512–8214; E-mail:

woodsw@gao.gov

SUPPLEMENTARY INFORMATION: Section

832 of the Floyd D. Spence National

Defense Authorization Act for Fiscal

Year 2001, Public Law 106–398, Oct. 30,

2000, directs the Comptroller General of

the United States to convene a panel of

experts to study the policies and

procedures governing the transfer of

commercial activities for the federal

government from government personnel

to a federal contractor. The Panel’s

study is to include a review of: (1)

procedures for determining whether

functions should continue to be

performed by government personnel; (2)

procedures for comparing the costs of

performing functions by government

personnel with the costs of performing

those functions by federal contractors;

(3) implementation by the Department

of Defense of the Federal Activities

Inventory Reform (FAIR) Act of 1998

(Pub. L. 105–270, 112 Stat. 2382, 31

U.S.C. 501 note); and (4) procedures of

the Department of Defense for publicprivate competitions under Office of

Management and Budget (OMB)

Circular A–76. Formation of the Panel

was announced in the Federal Register

on April 17, 2001 (66 FR 19786). By

May 1, 2002, the Comptroller General

must submit to Congress a report of the

Panel on the results of the study,

including recommended changes with

regard to implementing policies and

enactment of legislation.

During the course of its work, the

Panel will hold several public hearings.

Interested parties are invited to attend

these hearings to provide their

perspectives on sourcing issues. The

first public hearing will be held on June

11, 2001, in the Walsh-Reckord Hall of

States at One Massachusetts Avenue,

NW, Washington, DC. The hearing will

begin at 9:00 a.m. The focus of this first

hearing will be the principles and

policies underlying outsourcing.

Specifically, the Panel is interested in

hearing views on the principles and

policies that should govern decisions

concerning whether particular functions

should be performed by the public

sector or by the private sector. Future

hearings will focus on other aspects of

outsourcing.

Any party who would like to attend

the hearing or make a presentation

should contact William T. Woods at

(202) 512–8214 or woodsw@gao.gov.

Those who wish to make presentations

at the hearing should submit written

summaries of their oral statements via

E-mail or regular mail as indicated in

the ADDRESSES section by 5:30 p.m. on

June 4, 2001. The Panel will attempt to

accommodate all interested parties who

respond before the deadline. Each

presenter will have 3 to 5 minutes to

make an oral statement at the hearing.

Interested parties who would like to

make electronic presentations during

the hearing must indicate their desire to

do so by the June 4 deadline. More

detailed guidance on hearing

procedures will be provided to

presenters by E-mail in advance of the

hearing. Any interested party may

submit full statements for inclusion in

the hearing record by 5:30 p.m. on June

15. The hearing will be transcribed.

Two additional hearings currently are

planned outside of Washington, DC. A

public hearing will be held in

Indianapolis, Indiana, on August 8,

2001, which will focus on alternatives

to the public/private competitions

conducted pursuant to OMB Circular A–

76. Another public hearing will be held

in San Antonio, Texas, on August 15,

2001, and will address current processes

under OMB Circular A–76 and the FAIR

Act. Further information, including the

exact locations and times of these

hearings, will be announced in a later

Federal Register notice. In addition, a

notice was issued on March 23, 2001 (66

FR 16245), seeking submission of public

comments identifying significant

sourcing issues, as well as references to

or copies of written materials related to

these issues. The Panel will continue to

consider all such information received

at any time.

Electronic Access and Filing

This notice is available on GAO’s

website at http://www.gao.gov under

‘‘Commercial Activities Panel.’’

Requests to participate in the hearing,

electronic presentations, written

summaries of oral statements, full

statements, and other submissions

regarding outsourcing issues may be

sent via E-mail to A76panel@gao.gov.

Dated: May 18, 2001.

Jack L. Brock, Jr.,

Managing Director, Acquisition and Sourcing

Management, General Accounting Office.

[FR Doc. 01–13051 Filed 5–22–01; 8:45 am]

BILLING CODE 1610–02–P

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.

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,

28496 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

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 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 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 sciencesupporting efficacy in controlled

settings usually precedes evidence of

effectiveness when implemented large

scale in real world settings. The science

surrounding the effectiveness of AEDs,

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 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

28498 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

(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

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 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 inhouse 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

28500 Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices

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 electrodeto-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 nonjudgmental 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

Federal Register / Vol. 66, No. 100 / Wednesday, May 23, 2001 / Notices 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. Postevent 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 coworker 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 lifethreatening 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 coworker 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

BILLING CODE 6820–23–P

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

BILLING CODE 6820–23–C