Implementation of Provisions of the Ryan White Comprehensive AIDS Resources Emergency Act Regarding Emergency Response Employees

SUMMARY: The Ryan White Comprehensive AIDS Resources Emergency (CARE)

Act (Pub. L. 101-381) includes provisions for emergency response

employees (EREs) who may be exposed to potentially life-threatening

diseases during the course of an emergency. This notice sets forth the

final list of diseases to which these provisions apply; final

guidelines describing circumstances under which exposure to listed

diseases may occur; and final guidelines for determining whether an

exposure to the listed diseases has occurred. The final list of

diseases and guidelines incorporate comments received by CDC on a draft

list and guidelines (57 FR 54794, November 20, 1992).

DATES: The list of diseases and guidelines in this notice are effective

on March 21, 1994. All other applicable provisions of the Act

pertaining to this notice are effective on April 20, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. Robert Mullan, Centers for Disease

Control and Prevention, 1600 Clifton Road, NE., M/S F40, Atlanta, GA

30333, telephone (404) 639-0983.

SUPPLEMENTARY INFORMATION:

Introduction

The Ryan White CARE Act amended the Public Health Service Act to

include provisions regarding emergency response employees (EREs). (See

sections 2681-2690 of the PHS Act, 42 U.S.C. 300ff-81 to 300ff-90.

References are to Title 42 of the U.S. Code.)

Section 300ff-81 requires the development and publication of the

following: (1) A list of potentially life-threatening infectious

diseases to which EREs may be exposed in responding to emergencies; (2)

guidelines describing circumstances in which EREs may be exposed to

such diseases; and, (3) guidelines for medical facilities to determine

whether such exposure occurred.

Sections 300ff-82 through 300ff-83 specify that EREs must be

notified of exposure to any of the airborne infectious diseases on the

list and may request notification of exposure to other listed diseases.

Sections 300ff-84 and 300ff-85 specify the procedures for notifying

EREs when there has been an exposure to a listed disease. Under section

300ff-86, every State public health officer must designate an official

of every employer of EREs in the State who will be responsible for

notifying EREs of exposure. This official is referred to as the

Designated Officer. A medical facility that receives an infectious

patient to which an ERE may have been exposed is responsible for

notifying the Designated Officer that the ERE was exposed to a listed

disease.

Section 300ff-87 limits the time period for which medical

facilities must maintain medical information on patients and respond to

the request under section 300ff-83.

Under section 300ff-88 these provisions may not be construed to

authorize civil actions or penalties against a medical facility or

Designated Officer; to require a medical facility to test patients for

any infectious disease; to authorize or require the disclosure of

identifying information; or, to authorize any ERE to fail to respond,

or to deny services, to victims of emergencies.

Section 300ff-89 requires the Secretary of Health and Human

Services (the Secretary) to establish an administrative process through

which the Department can be notified of alleged violations of the

provisions and, as appropriate, investigate such alleged violations.

The Secretary may seek injunctive relief for violations of these

provisions.

Under section 300ff-90, the provisions of the Act and the

notification system do not apply in a State that has certified to the

Secretary that its notification laws are in substantial compliance with

the Act.

The list of diseases and guidelines specified in section 300ff-81

are effective on the date of publication. All other requirements of the

notification process take effect 30 days after the publication of the

list and guidelines.

This notice includes definitions (Part I), the final list of

potentially life-threatening diseases under section 300ff-81 (Part II),

the final guidelines required under section 300ff-81 (Part III), and

steps to implement sections 300ff-82-300ff-90 (Part IV). Three addenda

are provided for background and informational purposes: A. The text of

the Act; B. Excerpts concerning hepatitis B vaccination, and C.

References.

Responses to Comments

On November 20, 1992, CDC published in the Federal Register (57 FR

54794) a request for comments, including a draft of the required list

of infectious diseases and guidelines. CDC received comments from 101

individuals and/or organizations. CDC solicited comments to the

following questions:

What procedural steps can be taken to protect the

confidentiality of patient information subject to the provisions of the

Act?

Can the ERE notification process be carried out within

existing State confidentiality laws?

What will be the resource implications in carrying out

this legislation?

What are the likely benefits to be gained in implementing

these requirements?

Which States have notification laws that, under section

300ff-90, could be viewed as being in substantial compliance with the

Act?

CDC received a total of 275 comments in response to these

questions. In addition, there were 432 comments to other issues in the

notification process. The comments to the five specific questions and

the additional comments are addressed below.

1. What procedural steps can be taken to protect the

confidentiality of patient information subject to the provisions of the

Act?

According to section 300ff-88(c), this statute may not be construed

to authorize or require any medical facility, any designated officer of

emergency response employees, or any such employee, to disclose

identifying information with respect to a victim of an emergency or

with respect to an emergency response employee.''

CDC received 74 comments to the question regarding this provision.

Many of the comments expressed concern that the victim's

confidentiality could be breached. However, commenters also

acknowledged that EREs and medical facilities are already responsible

for protecting patient confidentiality and that additional protection

could be provided through training.

Other commenters were concerned with the possible liability for

medical facilities that provide patient information to Designated

Officers. The statute addresses liability only from the perspective of

failure to comply with duties established under the statute, not for

breaches of confidentiality. As in other situations involving patient

information, liability for breach of confidentiality is an issue of

State law.

Several commenters stated that informed consent must be obtained

before information on a victim could be provided to a Designated

Officer. The statute does not address informed consent and informed

consent to sharing patient information. Therefore, medical facilities

must look to State laws regarding informed consent and the sharing of

patient information.

The confidentiality provision (section 300ff-88[c]) must also be

read in relation to section 300ff-84, procedures for notification of

exposure. Under this later section, when a medical facility determines

that a victim had an airborne infectious disease or that an ERE was

exposed to an infectious disease on the list, the medical facility is

required to provide (1) the name of the infectious disease involved;

and (2) the date on which the victim of the emergency involved was

transported by emergency response employees to the medical facility

involved.'' These sections can be read together to mean that a medical

facility that provides the required information under section 300ff-84

is not disclosing identifying information under section 300ff-88(c).

States should review their confidentiality statutes and resolve any

conflict with this Federal legislation. Medical facilities must

determine whether, under their State and local laws, providing the

required information under section 300ff-84 violates State or local

confidentiality laws.

2. Can the ERE notification process be carried out within existing

State confidentiality laws?

CDC received responses to this question from 21 State health

departments. Of these States, 11 thought the notification process could

be implemented within the existing State confidentiality laws, 6 States

did not think it could, and 4 States indicated that it could be carried

out for some diseases, but not for other diseases, e.g., exposure to

human immunodeficiency virus (i.e., acquired immunodeficiency syndrome,

AIDS).

3. What will be the resource implications in carrying out this

legislation?

CDC received 86 responses to this question. The vast majority (75)

stated that the notification process would require an allocation of

resources. Several commenters expressed a belief that the cost would be

significant to medical facilities that are served by a large number of

EREs requesting notification.

4. What are the likely benefits to be gained in implementing these

requirements?

CDC received 41 comments to this question. Of these comments, 28

expressed doubt that the notification process would be beneficial to

EREs. According to the comments, the process was not projected to

confer many benefits because EREs are already covered by the

Occupational Health and Safety Administration's Bloodborne Pathogens

Standard, and because EREs should be using universal precautions. The

13 commenters who stated the process would be beneficial believed that

it would increase uniformity in notification of EREs, reduce

noncompliance among medical facilities in informing EREs of exposures,

and provide additional protection to EREs.

5. Which States have notification laws that, under section 300ff-

90, could be viewed as being in substantial compliance with the Act?

Under section 300ff-90, the requirements under the Act do ``not

apply in a State if the chief executive officer of the State certifies

to the Secretary that the law of the State is in substantial compliance

with'' the Act.

A total of 30 commenters responded to this question. Of these, 14

said that their State would be in substantial compliance with the law

and 16 said that their State would not be in compliance with the law.

Two commenters said that States should be allowed latitude in the

determination whether they are in substantial compliance with the Act.

Another commenter requested criteria that would be used to determine

whether a State is in substantial compliance. However, the Act does not

list any criteria for determining whether a State is in substantial

compliance with the provisions of the Act. Therefore, CDC will accept

the certification from the chief executive officer or designee of a

State who certifies that the State is in substantial compliance with

the Act. The certification must include the State statute(s) or

regulation(s) upon which the certification is based. However, under

section 300ff-89, the Secretary retains the authority to ``commence a

civil action to obtain temporary or permanent injunctive relief with

respect to any violation of'' the Act.

6. List of diseases.

Under section 300ff-81, the Secretary must develop ``a list of

infectious disease to which emergency response employees may be exposed

in responding to emergencies. The list * * * shall include a

specification of those infectious diseases on the list that are

routinely transmitted through airborne or aerosolized means.''

CDC received 31 comments to the draft list.

According to one commenter, ``uncommon or rare diseases'' should be

deleted. However, the legislation calls for the list to include

potentially life-threatening diseases regardless of their incidence.

Therefore, the rarity of a disease should not determine whether it is

included on the list.

Other commenters suggested adding chicken pox, syphilis, childhood

diseases, and meningitis to the list. These diseases are not

appropriate for the list because chicken pox is not generally life-

threatening, syphilis does not pose a significant risk of transmission

if an ERE is exposed to an infectious patient, and childhood diseases

(i.e., measles and rubella) are not life-threatening to the ERE.

Meningococcal disease is already on the list. Another commenter noted

that meningococcal disease is not rare, and that it is transmitted

through direct contact, and that the ERE is not likely to be aware of

exposure. As noted in Part III, ``Under special circumstances, C.

diphtheriae, N. meningitidis, and Y. pestis could be transmitted to

EREs by direct contact with droplets from the respiratory tract of

infected persons. However, such transmission is rare.'' Although one

commenter recommended that diphtheria and meningococcal disease be

classified as airborne diseases, they are transmitted by direct contact

only. Likewise, another reviewer recommended that hemorrhagic fevers be

classified as bloodborne diseases, rather than as uncommon or rare

diseases. Although the hemorrhagic fevers have been reported to have

been transmitted via inoculation with contaminated needles,\1\ it was

decided to place the entire group under the uncommon or rare disease

category to emphasize the decreased probability of exposure to these

diseases.

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\1\Benenson AS (ed). Control of communicable diseases in man.

Washington, D.C.: The American Public Health Association, 15th

edition, 1990.

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It was also suggested that hepatitis C be deleted because of

difficulty in interpretation of laboratory test, lack of routine test

availability, and the lack of definitive treatment. Hepatitis C has

been removed from the list at this time for the following reasons:

Available laboratory tests do not distinguish between current or past

infections, evidence of transmission in the health care setting is

limited, and the withdrawal by the Immunization Practices Advisory

Committee of its recommendations for prophylaxis with immune serum

globulin following percutaneous exposure to hepatitis C. Moreover,

there are no specific recommendations for following workers after an

exposure incident involving hepatitis C. CDC will continue to monitor

the scientific literature on hepatitis C, however, and if new

information becomes available that suggests that hepatitis C should be

returned to the list of diseases contained here, CDC will amend the

list.

A number of comments were received regarding tuberculosis. One

commenter stated that tuberculosis is not life threatening, which

should be noted in the regulation. However, tuberculosis, especially

multiple drug-resistant tuberculosis (MDR-TB), can pose a threat to

life; therefore it will remain in the list. Another commenter

recommended that the list should specify tuberculosis disease as

infectious ``pulmonary'' TB. This recommendation has been incorporated

into the list.

It was also recommended that tuberculosis should be deleted from

the list since no emergency treatment is indicated and EREs are

required to have annual skin tests. However, in the event of a

recognized exposure to tuberculosis, employees should be skin tested

six weeks thereafter for conversion. In the event of a conversion, a

decision concerning chemoprophylaxis should be made as soon as

feasible.

One commenter suggested CDC reorganize the list of diseases into

``mandatory reporting'' and ``exposure-triggered reporting.'' However,

it was thought that the current organization made the most sense, since

``exposure-triggered reporting'' is still ``mandatory,'' if an

infectious disease exposure occurs that meets the criteria set forth in

the Act. Some commenters thought the division of diseases into airborne

and other modes of transmission was unnecessary. The diseases are

distinguished by their mode of transmission because, under section

300ff-81(b), the statute requires a ``specification of those infectious

diseases on the list that are routinely transmitted through airborne or

aerosolized means.''

Many States commented that they already have a more comprehensive

list of diseases requiring reporting. A more comprehensive list of

diseases is not prohibited by the legislation; therefore, States may

add diseases to the list, but no diseases on the list published herein

may be removed by a State.

7. Definitions.

Under section 300ff-76, definitions for some of the terms applied

in the statute can be found. Where it was necessary, additional

definitions were added to the draft for clarification. A total of 32

comments regarding the definitions used in the notification process

were received.

One commenter requested the definition of ``Secretary'' be added to

the definitions to clarify that it is the Secretary of the Department

of Health and Human Services who is responsible for injunctions under

section 300ff-89. Therefore, the definition of ``Secretary'' has been

added to the definitions.

Many commenters requested a definition of medical facility. This

term was not defined in the Act, therefore, a definition of medical

facility has been added to the list of definitions. A medical facility,

for purposes of this statute, is any facility that treats victims of

emergencies.

One commenter requested clarification whether the definition of an

ERE included ``non-governmental EREs.'' The definition of EREs includes

employees of non-governmental organizations. One commenter recommended

that law enforcement personnel be included under the definition of

EREs. Under the Act, the definition of EREs includes law enforcement

officers.'' One commenter stated that it is unclear whether EREs who

treat a victim but do not transport the victim are covered under the

Act. Under section 300ff-82, when a medical facility makes a

determination that a victim has an airborne infectious disease, the

medical facility must notify only the Designated Officer of the EREs

who transported the victim, not those who also treated the victim.

However, under section 300ff-83, any ERE who ``attended, treated,

assisted, or transported'' a victim may submit a request for a

determination whether there was an exposure to an infectious disease.

Therefore, under section 300ff-82, the medical facility is required to

notify those EREs who transported a victim who has an airborne

infectious disease, even when the ERE has not made a request for

notification. For these EREs, section 300ff-82 does not require the

medical facility to determine whether the ERE was exposed to the

infectious disease. Under section 300ff-83, EREs who attended, treated,

assisted, or transported a victim can request a determination from the

medical facility of whether the ERE was exposed to an infectious

disease from a victim. This determination would include a determination

of whether an ERE was exposed to a victim of an airborne infectious

disease.

One commenter requested a definition of ``public health officer''

where, under section 300ff-83(g), a designated officer requests the

assistance of the public health officer. Under that section, ``the

public health officer for the community in which the medical facility

is located shall evaluate'' a request from a designated officer to a

medical facility where the medical facility finds that there is

insufficient information to determine whether the ERE was exposed to a

disease. Designated Officers must determine who the public health

officer for the community is where the medical facility is located

based on the jurisdiction where the medical facility is located, i.e.,

whether the community is a city or county.

The majority of comments received on the definitions related to the

definition of ``exposed'' as it is defined in the statute and applied

in the notification process.

The term ``exposed'' is found in two sections of the statute. Under

section 300ff-81, the Secretary must develop the following: ``a list of

potentially life-threatening infectious diseases to which emergency

response employees may be exposed in responding to emergencies;

guidelines describing the circumstances in which such employees may be

exposed to such diseases * * *; [and] guidelines describing the manner

in which medical facilities should make determinations for purposes of

section 300ff-83(d).'' Under section 300ff-83(d), the medical facility

must evaluate the facts submitted by a Designated Officer and make a

determination whether, on the basis of the medical information

possessed by the facility regarding the victim involved, the emergency

response employee was exposed to an infectious disease included on the

list, according to the guidelines issued by the Secretary.

Under section 300ff-76(6), ``the term `exposed,' with respect to

HIV disease, or any other infectious disease, means to be in

circumstances in which there is a significant risk of becoming infected

with the etiologic agent for the disease involved.'' Neither the

statute nor the legislative history of the statute provide any

additional information regarding the definition of significant risk.

Therefore, without statutory or legislative elucidation as to the

meaning of significant risk'', the term can be understood with

reference to its use in other circumstances.

Under the Supreme Court case School Board of Nassau County v.

Arline, the Court listed the criteria by which it could be determined

whether an individual poses a ``significant risk'' to others (480

U.S.C. 273, 288). These criteria were recommended by the American

Medical Association and included:

A finding of facts, based on reasonable medical judgments given the

state of medical knowledge, about

(a) The nature of the risk (how the disease is transmitted),

(b) The duration of the risk (how long is the carrier infectious),

(c) The severity of the risk (what is the potential harm to

others), and

(d) The probabilities the disease will be transmitted and will

cause varying degrees of harm.

Subsequently, these criteria were incorporated into the definition

of ``direct threat'' under the Americans With Disabilities Act. (See

Senate Report No. 101-116, 101st Congress, 1st Session, 1989, page 40.)

These criteria have been incorporated into the definition of

``exposed'' and into the guidelines under section 300ff-81(a)(2).

One commenter suggested that a system should be established that

specifies the information required from a Designated Officer regarding

exposure, thereby reducing the chance for confusion or insufficient

information. Such a system is not required under the statute and has

not been developed. The parties involved in this system must be given

the latitude to develop procedures appropriate for their situation.

Several commenters stated that the determination of exposure is

complex and should be left to public health or occupational health

officials and that the determination of exposure cannot be the

responsibility of the medical facility. The responsibility for

determining exposure is specified in the statute and rests with medical

facilities. This process cannot be altered by CDC.

Commenters also noted the need for more ``user-friendly'' exposure

determination guidelines for Designated Officers with no medical

background. The guidelines for Designated Officers describe the

circumstances in which employees may be exposed to the diseases on the

list. These guidelines are as succinct as possible within the

specifications of the statute.

It was noted that exposure to persons undergoing tuberculosis drug

therapy and skin test converters, who are not infectious, should not be

reported. CDC agrees with this comment and it is addressed under

Comments on the Disease List. Another comment on tuberculosis stated

that the section on airborne diseases is a problem because merely

sharing air space is not sufficient to transmit tuberculosis and would

not require treatment or followup. However, sharing air space is the

main route of transmission for tuberculosis. EREs who transport

patients with infectious TB are at risk of infection and should be

medically evaluated.

One individual asked whether States are ultimately responsible for

determining which circumstances constitute exposure and whether State

health officers or other professionals have input in this

determination. Under the statute, in the case of airborne transmission,

no determination of exposure must be made: if the medical facility

determines that the victim has an airborne disease, the facility must

notify the Designated Officer of the ERE who transported the victim. In

the case of bloodborne exposures, it is the responsibility of

Designated Officers and medical facilities to make these determinations

based on the guidelines.

One commenter stated that the duties of the medical facility should

apply, as long as there is documentation that an ERE may have been

exposed to one of the listed diseases. However, the period for which

medical facilities must retain information on a victim is limited by

section 300ff-87.

As suggested by commenters, in section III.A.2 a recommendation has

been added that when an exposure incident occurs or there is a breach

of universal precautions, OSHA's Bloodborne Pathogens Standard

protocols should be followed. Also, in defining occupational exposure

to bloodborne pathogens, skin contact is limited to contact with non-

intact skin.

One commenter suggested that ERE employers should provide, at no

cost, counseling and medical evaluation, medical treatment, or

prophylaxis whenever EREs are notified of occupational exposure. This

suggestion is consistent with the OSHA Bloodborne Pathogens Standard.

However, the Act does not require compliance with these provisions.

One commenter stated that rural States with low prevalence of HIV

and hepatitis B virus infection do not need a sophisticated

notification system as specified under this legislation. However, the

statute does not allow for distinguishing between States with high and

low prevalences of the notifiable diseases.

One commenter stated that the use of Control of Communicable

Diseases in Man is not adequate to make exposure determinations.

Control of Communicable Diseases in Man is intended to serve in

conjunction with prior infection control training and experience of the

Designated Officer in making exposure determinations.

8. First responders.

Several commenters stated that first responders should be covered

under the notification system established by the Act, while one stated

they should not be covered. First responders are individuals who have

other responsibilities within an organization but who also, as part of

their official responsibilities or as a volunteer, respond to

emergencies that occur. Whether first responders are covered under the

Act depends upon whether they fit within the definition of an ERE. The

definition of ERE includes ``firefighters, law enforcement officer,

paramedics, emergency medical technicians, and other individuals

(including employees of legally organized and recognized volunteer

organizations, without regard to whether such employees receive nominal

compensation) who, in the course of professional duties, respond to

emergencies in the geographic area involved.'' Therefore, for first

responders to be covered by the Act, they must respond to emergencies

as part of their professional duties.

9. Patient testing.

Twelve comments regarding the patient testing provision of the Act

were received. Patient testing is addressed under 300ff-88(b). This

section states that the Act ``may not, with respect to victims of

emergencies, be construed to authorize or require a medical facility to

test any such victim for any infectious disease.''

One commenter recommended that patient testing be mandatory and

others suggested that this provision establishes an incentive to test

patients. One other comment recommended routinely testing victims for

tuberculosis. The Act does not authorize mandatory patient testing.

Several commenters requested that the testing provision be

incorporated into the guidelines for clarification. This has been done

in a footnote to section III.C.3.

Several comments addressed patient consent for testing. One

commenter suggested that consent should be requested when knowledge of

the patient's infected status is necessary in order to determine

whether there has been an exposure. The Act does not prohibit seeking

patient consent where consent is required in order to test the patient.

Other commenters stated that, in their medical facility, patient

consent is necessary before a patient can be tested. Whether consent is

required in order to test a patient is a matter of State laws. Medical

facilities should consult their State health department or other

regulatory agency for State laws and regulation on patient consent.

The patient testing provision must also be read in conjunction with

the provisions of OSHA's Occupational Exposure to Bloodborne Pathogens

Standard (29 CFR part 1910). Under OSHA's standard, following a report

of an exposure incident, ``(A) [t]he source individual's blood shall be

tested as soon as feasible and after consent is obtained in order to

determine HBV and HIV infectivity. If consent is not obtained, the

employer shall establish that legally required consent cannot be

obtained. When the source individual's consent is not required by law,

the source individual's blood, if available, shall be tested and the

results documented'' (29 CFR Sec. 1910.1030(f)(3)(A)). Therefore, while

the ERE notification system established under the Act does not

authorize or require a medical facility to test a victim for any

infectious disease, other laws or regulations may require or permit

testing of victims. Also, other laws, particularly State laws, may

address patient consent to testing. When there has been an exposure,

employers should follow the OSHA Bloodborne Pathogens Standard and

applicable State and local laws regarding patient testing and consent.

10. 30-day implementation period.

Under the Act, the provisions of the notification system take

effect 30 days after publication of the list of diseases and guidelines

under section 300ff-81. (42 U.S.C. 300ff-80 note.) Of the twenty

comments received regarding this provision, nineteen stated that the

30-day period was insufficient to implement the provisions of the Act.

However, the 30-day implementation provision is statutorily defined,

and CDC cannot alter it.

11. 48-hour notification period.

Under section 300ff-82(b), a medical facility must inform the

Designated Officer as soon as is practicable, but not later than 48

hours, when it determines that a victim has an airborne infectious

disease, including when the victim dies before reaching the medical

facility. The same time limitation applies, under section 300ff-83(e),

when it determines that an ERE requesting notification was or was not

exposed to an infectious disease.

Of the comments received, fifteen stated that the statutory time

frame for reporting was too short. In general these comments reflected

the position that it would be difficult for medical facilities to

comply with the time frame due to staff shortages, low weekend

coverage, and occasions when appropriate medical personnel are

unavailable. An additional nine comments stated that the time frame was

too long. Several commenters stated that 48 hours was too long to wait

for notification when the ERE has been exposed to meningococcal disease

due to its incubation period. Another commenter stated that 48 hours is

unacceptable for exposure to cases of plague, rabies, and hepatitis B.

Since the time limits are established in the Act, they cannot be

altered. However, it should be noted that, in the case of an airborne

disease, notification is not required until a determination has been

made that the victim has such a disease. The time limit begins after

such a determination is made. For other diseases, if, after 48 hours,

exposure cannot be determined without additional information, the

medical facility must inform the designated officer that there are

insufficient facts to make a determination or that the facility does

not have the necessary information on a victim to determine whether the

victim has a disease on the list of diseases.

Both medical facilities and designated officers should be aware of

the provisions of section 300ff-87 regarding time limits and

information available on a victim. This section states that the duties

of medical facilities under the Act

(1) Shall apply only to medical information possessed by the

facility during the period in which the facility is treating the victim

for conditions arising from the emergency, or during the 60-day period

beginning on the date on which the victim is transported by emergency

response employees to the facility, whichever period expires first; and

(2) Shall not apply to any extent after the expiration of the 30-

day period beginning on the expiration of the applicable period

referred to in paragraph (1), except that such duties shall apply with

respect to any request under section 300ff-83(c) received by a medical

facility before the expiration of such 30-day period.

One commenter requested clarification as to the meaning of this

language. Subsection (1) establishes the time limit for which a medical

facility must retain information on a victim of an emergency. The

meaning of subsection (2) is somewhat ambiguous. Accordingly, the two

subsections are interpreted and will be applied to mean that the duties

of medical facilities terminate at the end of the period during which

the facility provides medical care to the victim for conditions arising

from the emergency, or at the end of the 60-day period beginning on the

date on which the victim is transported by EREs to the facility,

whichever period is shorter. However, the duties of the medical

facility shall continue if, under section 300ff-83(c) a request is

received within 30 days of the date of the applicable period under

subsection (1) of section 300ff-87. In practice, if a victim is

transported to a medical facility and released after two days, the

facility must respond to a request submitted under section 300ff-83(c)

if the request is received within 30 days of the date the victim was

discharged from the facility. Also, if a victim of an emergency is

transported to a medical facility and remains in the facility for more

than 60 days, the facility must respond to a request under section

300ff-83(c) when the request is received within 30 days from the

expiration of the 60-day period.

12. Designated Officers

Under 42 U.S.C. 300ff-87:

(a) For the purposes of receiving notifications and responses and

making requests * * * on behalf of emergency response employees, the

public health officer of each State shall designate 1 official or

officer of each employer of emergency response employees in the State.

(b) In making the designations required in section (a), a public

health officer shall give preference to individuals who are trained in

the provision of health care or in the control of infectious diseases.

A total of 56 comments regarding these provisions were received.

The majority of comments stated that it is impractical for State public

health officers to make such designations due to the large number of

employers of EREs in the State, the high turnover rate among some

employees, and the lack of individuals trained in the control of

infectious diseases among some employers of EREs. Other commenters

stated that it would be more efficient for employers to designate the

official or officer for their EREs. In order to address the concern

that designating an official or officer for each employer of EREs is

impractical or too burdensome on State public health officers, it would

be permissible for States to allow employers to submit the name of an

individual whom the employer would like for the State public health

officer to designate as the designated officer for the employer.

Many commenters recommended that the Designated Officer should be a

physician or, in one comment, an epidemiologist or infection control

practitioner. Many other commenters stated that it will be very

difficult for employers to have a designated officer who is qualified

to make the determinations required under the statute. Regarding the

qualifications of the Designated Officer, the statute only requires

that the State public health officer ``give preference to individuals

who are trained in the provision of health care or in the control of

infectious disease.'' While, under the statute, a State public health

officer cannot require an employer to have a physician as the

Designated Officer, employers can recommend to the State public health

officer that a physician who is an employee be designated as the

Designated Officer. In those cases where an employer does not consider

any employee qualified to act as the Designated Officer, a qualified

individual, such as a physician, could be retained by the employer to

serve solely as the Designated Officer.

A number of commenters suggested permitting the State public health

officer to designate a regional Designated Officer, who could function

in that capacity for several employers. This would be permitted under

the statute only where the regional designated officer is also an

employee of all the employers in the specified region.

Two commenters stated that the duties of the Designated Officers

may create liability for them. While the duties of the Designated

Officer may create liability issues under State law for acts or

omissions, the statutes provides that it * * * may not be construed to

authorized any cause of action for damages or any civil penalty against

any * * * designated officer, for failure to comply with the duties

established. * * *''

13. Comments on prevention.

CDC received 44 comments regarding preventing disease in EREs. It

was suggested that if EREs are using universal precautions, then there

would not be a need for this regulation. However, universal precautions

do not address airborne disease transmission. Moreover, universal

precautions cannot protect entirely from inadvertent needlestick

injury.

It was also suggested that EREs may become lax regarding compliance

with universal precautions if they know they can get patient

information. Since exposure precedes notification, notification is not

expected to deter EREs in the practice of universal precautions.

One commenter thought that the concept of body substance isolation

should be used instead of universal precautions. As noted under

III.A.2, ``Under emergency circumstances in which differentiation

between fluid types is difficult, if not impossible, all body fluids

are considered potentially hazardous.'' This is essentially body

substance isolation.

One commenter suggested that, to avoid confusion and duplication,

CDC should adopt language crafted by OSHA in their Bloodborne Pathogens

Standard and tuberculosis compliance memorandum. This was agreed to; as

noted above, several changes have been made to bring the two documents

into closer alignment.

One commenter suggested that purified protein derivative (PPD)

testing should be given to EREs every 6 months. CDC recommends that

tuberculin skin testing be performed every 6 months in areas where

there is a high risk for tuberculosis transmission. For other, lower-

risk areas, annual tuberculin skin testing is recommended.

One commenter stated that EREs need to be trained to recognize

symptoms of active tuberculosis. CDC agrees with this.

Another commenter noted that patients suspected of having active

tuberculosis should be tested and isolated in a timely manner. CDC

acknowledges that this is a key concept in tuberculosis control

efforts.\2\,\3\

---------------------------------------------------------------------------

\2\CDC. Guidelines for preventing the transmission of

tuberculosis in health-care facilities, with special focus on HIV-

related issues. MMWR 1990;39(no. RR-17).

\3\CDC. Draft Guidelines for Preventing the Transmission of

Tuberculosis in Health-Care Facilities, Second Edition. Federal

Register 1993:58 (no. 195):52810-52854, October 12.

---------------------------------------------------------------------------

One commenter thought that CDC should explain if or how the

proposed notification requirements will reduce transmission of airborne

disease and how they will fit into the infection control strategy

outlined in the 1990 CDC Guidelines for Preventing the Transmission of

Tuberculosis in Health Care Settings. There is no conflict between

these requirements and either the 1990 document\4\ or the 1993 draft

Guidelines.\5\

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\4\See footnote 2.

\5\See footnote 3.

---------------------------------------------------------------------------

One commenter noted that tetanus/diphtheria boosters should be

given every 10 years. This is current CDC policy.\6\

---------------------------------------------------------------------------

\6\CDC. General recommendations on immunization. Recommendations

of the Advisory Committee on Immunization Practices (ACIP) MMWR

1994; 43(No. RR-1).

---------------------------------------------------------------------------

One commenter thought that diphtheria vaccination virtually

eliminates the possibility of occupational transmission. This is true;

notification of exposure then provides an impetus for ensuring that

diphtheria vaccination has been obtained recently enough to ensure that

immunity has been maintained.

It was also suggested that infection control education programs are

needed for EREs. However, the legislation is not directed to this need.

The OSHA Bloodborne Pathogens Standard has provisions for employee

training programs for bloodborne pathogens.

For plague and rabies, it was noted that education offers the best

prevention against infection. Nonetheless, notification and follow-up

are indicated upon potential exposure to either of these diseases.

One commenter proposed that an ERE who sustains significant

exposure should be assured counseling and testing, and that this is

more important than inordinate efforts to determine patient HIV status.

CDC believes that counseling and testing are key elements in follow-up

of an employee exposure to a potentially life-threatening infectious

disease. Additional language from the OSHA Bloodborne Pathogens

Standard has therefore been appended in Addendum B for follow-up of a

potential HIV exposure: ``Following a report of an exposure incident,

the employer shall make immediately available to the exposed employee a

confidential medical evaluation and follow-up including at least the

following elements: * * * counseling.''

One commenter stated that medical facilities should not be

responsible for follow-up testing of EREs. There is no provision in the

legislation that charges medical facilities with follow-up testing of

EREs.

One commenter suggested that regulation provides little incentive

for ERE employers to adopt infection control plans. The threat of HIV

infection should provide a powerful incentive for implementation of

infection control plans. Moreover, there are Federal agencies and other

organizations that require and recommend infection control procedures

(e.g., OSHA and the National Fire Protection Administration).

14. Airborne versus bloodborne.

Ten comments were received regarding notification for airborne

diseases versus notification for other diseases. It was suggested that

EREs should be notified of all the listed diseases, not just airborne

diseases, without making a request, and that the ERE request should be

a ``back-up.'' This is not consistent with the legislation.

One commenter suggested that in making a distinction between

airborne and bloodborne exposures, the Act frustrates its intent,

placing the burden on the ERE to request determinations of bloodborne

exposures. The commenter thought that this would lead to more requests

than if all diseases were treated alike. Again, this concept is not

consistent with the legislation.

15. Coordination with OSHA.

Ten comments were received regarding this notification system and

requirements of the OSHA Bloodborne Pathogens Standard.

In one response, CDC was urged to cooperate with OSHA to develop a

joint advisory notice on tuberculosis. However, OSHA has announced its

intention to promulgate an occupational health standard addressing

tuberculosis and other airborne pathogens. CDC will be assisting OSHA

in this regulatory effort.

Another commenter felt that CDC should require States without State

plan OSHA programs to develop worker protection programs at least as

effective as those in the already Federally approved States. States

without State OSHA plans are already covered by Federal OSHA programs.

One commenter thought it was unclear how the notification process

interfaces with OSHA regulations and that there appeared to be

duplication. Since a significant portion of EREs are not covered by

OSHA regulations, some degree of overlap is inescapable.

One reviewer stated that the draft notification process recommended

that workers be immunized with hepatitis B virus vaccine,'' but noted

that this is a requirement under the OSHA Bloodborne Pathogens

Standard. The recommendation for immunization was added for those EREs

not covered by the OSHA Bloodborne Pathogens Standard. The OSHA

requirement is presented in Addendum B.

Several commenters noted that the definition of bloodborne

transmission is inconsistent with the OSHA Bloodborne Pathogens

Standard's use of the term ``other potentially infectious material.''

Part III.2 has been expanded to comply with the OSHA definition.

One commenter asked whether the Designated Officer represents the

employer or the employee. According to the commenter, it would be

inconsistent under the OSHA Bloodborne Pathogens Standard for the

Designated Officer to represent the employee. In the ERE notification

system, the Designated Officer is acting in the interest of the

employee. This is not seen as inconsistent with OSHA regulations,

however, since employers are still required to meet the notification

provisions of the OSHA Bloodborne Pathogens Standard. In addition, many

EREs are not covered by OSHA regulations.

One commenter stated that his State has an approved occupational

safety and health plan, and suggested that the notification process

therefore is redundant. As noted in section 300ff-90, ``this [ERE

portion of the Act] shall not apply in a State if the chief executive

officer of the State certifies to the Secretary that the law of the

State is in substantial compliance with this subpart.''

One commenter suggested that all medical facilities are covered by

OSHA regulations regarding exposure; therefore, Designated Officers

should be aware of them and educate EREs. In fact, not all medical

facilities are covered by OSHA (e.g., public hospitals in states

without State OSHA plans). Moreover, EREs are not typically employees

of the medical facility, thus necessitating another route of

notification to that provided by the OSHA Bloodborne Pathogens

Standard.

16. Injunctive relief.

Authority for injunctive relief is provided in section 300ff-89.

This section states:

(a) The Secretary may, in any court of competent jurisdiction,

commence a civil action for the purpose of obtaining temporary or

permanent injunctive relief with respect to any violation of [these

provisions].

(b) The Secretary shall establish an administrative process for

encouraging emergency response employees to provide information to the

Secretary regarding violations of [these provisions]. As appropriate,

the Secretary shall investigate alleged such violations and seek

appropriate injunctive relief.

Regarding subsection (b) of these provisions, anyone alleging a

violation of any of these provisions should contact CDC. Alleged

violations of these provisions will be investigated. In any case that

injunctive relief may be sought, the Department of Health and Human

Services will coordinate its efforts with the Department of Justice.

Final Notice: Provisions of Section 411 of the Ryan White Comprehensive

AIDS Resources Emergency Act Regarding Emergency Response Employees

Section 411 of the Ryan White Comprehensive AIDS Resources

Emergency (CARE) Act (Pub. L. 101-381), amends the Public Health

Service Act to include provisions regarding emergency response

employees (sections 2681-2690 of the PHS Act, 42 U.S.C. 300ff-81 to

300ff-90). This notice sets forth the final list of diseases; final

guidelines describing circumstances under which exposure to infectious

diseases may occur; and final guidelines for determining whether an

exposure to such a disease has occurred, as required under section 411

of the Act. The final list of diseases and guidelines incorporate

comments received by CDC to the draft list and guidelines (57 FR 54794,

November 20, 1992). The list of diseases and guidelines are effective

on March 21, 1994. All other provisions of section 411 of the Act are

effective on April 20, 1994.

CDC will continue to monitor the scientific literature on

infectious diseases. If new information becomes available that suggests

that additional infectious diseases should be added to the list of

diseases contained here, CDC will amend the list.

Dated: March 15, 1994.

Walter R. Dowdle,

Deputy Director, Centers for Disease Control and Prevention (CDC).

Contents

Part I. Definitions

Part II. List of Potentially Life-Threatening Infectious Diseases to

Which Emergency Response Employees Can Be Exposed

Part III. Guidelines for Determining Exposure

Part IV. Implementation of the Law

Addendum A: Background--Text of Sections 2681-2690 of the PHS Act as

amended by Pub. L. 101-381 (42 U.S.C. 300ff-81 to 300ff-90)

Addendum B: Excerpts Concerning Hepatitis B Vaccination

Addendum C: References

Statutory citations within this notice are to the Title 42 of

the U.S. Code.

Part I. Definitions

Aerosol. Small particles of matter that float on air currents.

Airborne transmission. Person-to-person transmission of an

infectious agent by an aerosol.

Bloodborne transmission. Person-to-person transmission of an

infectious agent through contact with an infected person's blood.

Designated Officer of Emergency Response Employees. An

individual designated under 42 U.S.C. 300ff-86 by the public health

officer of the State involved (42 U.S.C. 300ff-76).

Emergency. An emergency involving injury or illness (42 U.S.C.

300ff-76).

Emergency response employees (EREs). Firefighters, law

enforcement officers, paramedics, emergency medical technicians, and

other persons (including employees of legally organized and

recognized volunteer organizations, without regard to whether such

employees receive nominal compensation) who, in the course of

professional duties, respond to emergencies in the geographic area

involved (42 U.S.C. 300ff-76).

Employer of Emergency Response Employee. An organization that,

in the course of professional duties, responds to emergencies in

that geographic area involved (42 U.S.C. 300ff-76).

Exposed. With respect to HIV disease or any other infectious

disease, to be in circumstances in which there is a significant risk

of becoming infected with the etiologic agent for the disease

involved (42 U.S.C. 300ff-76).

Medical Facility. Any facility that receives victims of

emergencies who are transported to the facility by emergency

response employees.

Patient. A victim of an emergency who has been aided by an

Emergency Response Employee and has been transported to a medical

facility.

Potentially life-threatening infectious disease. An infectious

disease that can cause death in a healthy, susceptible host.

Routinely transmitted by aerosol. A disease that is usually

transmitted via the aerosol route.

Secretary. The Secretary of the Department of Health and Human

Services as this term is used in Title XXVI of the Public Health

Service Act (42 U.S.C. 300ff-80 through 42 U.S.C. 300ff-90).

Significant Risk. A finding of facts relating to a human

exposure to an etiologic agent for a particular disease, based on

reasonable medical judgments given the state of medical knowledge,

about

(a) The nature of the risk (how the disease is transmitted),

(b) The duration of the risk (how long an infected person may be

infectious),

(c) The severity of the risk (what is the potential harm to

others) and

(d) The probabilities the disease will be transmitted and will

cause varying degrees of harm.

Part II. List of Potentially Life-Threatening Infectious Diseases

to Which Emergency Response Employees Can be Exposed

In developing the list of infectious diseases to which EREs can

be exposed, CDC used the following criteria:

1. The disease is potentially life-threatening, i.e., it carries

a significant risk of death if acquired by a healthy, susceptible

host, and

2. The disease can be transmitted from person to person.

A. Airborne Diseases

Infectious pulmonary tuberculosis (Mycobacterium tuberculosis)

B. Bloodborne Diseases

1. Hepatitis B

2. Human immunodeficiency virus infection (including acquired

immunodeficiency syndrome [AIDS])

C. Uncommon or Rare Diseases

1. Diphtheria (Corynebacterium diphtheriae)

2. Meningococcal disease (Neisseria meningitidis)

3. Plague (Yersinia pestis)\7\

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\7\During the 1980s, a mean of 18 cases of plague was reported

annually in persons exposed in enzootic areas of the southwestern

United States. Thus, normally only EREs in this area face potential

occupational exposure to plague.

---------------------------------------------------------------------------

4. Hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-Congo, and

other viruses yet to be identified)

5. Rabies

Part III. Guidelines for Determining Exposure

A. Circumstances Under Which Exposure can Occur

1. Airborne Diseases

Infectious pulmonary tuberculosis (Mycobacterium tuberculosis)

Occupational exposure to airborne pathogens may occur when an

ERE shares air space with a patient who has an infectious disease

caused by an airborne pathogen.

2. Bloodborne Diseases

Human immunodeficiency virus infection (including acquired

immunodeficiency syndrome [AIDS])

Hepatitis B

Occupational exposure to bloodborne pathogens may occur as the

result of contact during the performance of normal job duties with

blood or other body fluids to which universal precautions apply.

When EREs have contact with body fluids under emergency

circumstances in which differentiation between fluid types is

difficult, if not impossible, all body fluids are considered

potentially hazardous. Universal precautions, as outlined in

Guidelines for Prevention of Transmission of Human Immunodeficiency

Virus and Hepatitis B Virus to Health-Care and Public-Safety

Workers, are recommended for all EREs to reduce the risk of exposure

to bloodborne pathogens. In the Occupational Safety and Health

Administrations Bloodborne Pathogens Standard, an exposure incident

is defined as a ``specific eye, mouth, other mucous membrane, non-

intact skin, or parenteral contact with blood or other potentially

infectious materials that results from the performance of an

employee's duties.'' Bloodborne pathogens are defined therein as

``pathogenic microorganisms that are present in human blood and can

cause disease in humans. These pathogens include, but are not

limited to, hepatitis B virus (HBV) and human immunodeficiency virus

(HIV).''\8\

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\8\Occupational Safety and Health Administration. Occupational

exposure to bloodborne pathogens: final rule. 29 CFR Part 1910.1030.

Federal Register, December 6, 1991.

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These precautions, and other provisions of the Occupational

Safety and Health Administration (OSHA) rule governing occupational

exposure to bloodborne pathogens (29 CFR 1910.1030), may be

mandatory for some EREs, depending upon whether they are employed in

the public or private sector and whether the State in which they are

employed has an approved occupational safety and health plan.

Employers covered under the OSHA Bloodborne Pathogens Standard

should comply with provisions contained in the standard when there

is an exposure incident or a breach of universal precautions.

Also, it is recommended that workers with occupational exposure

to blood be vaccinated with hepatitis B vaccine (see Addendum B).

3. Uncommon or Rare Diseases

Diphtheria (Corynebacterium diphtheriae)

Meningococcal disease (Neisseria meningitidis)

Plague (Yersinia pestis)

Hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-Congo, and other

viruses yet to be identified)

Rabies

While person-to-person transmission of pathogens in this

category is rare or theoretical, infection with any of these

pathogens could be life-threatening. Under special circumstances,

Corynebacterium diphtheriae, Neisseria meningitidis, and Yersinia

pestis could be transmitted to EREs by direct contact with droplets

from the respiratory tract of infected persons. However, such

transmission is rare. Person-to-person transmission of plague, for

example, has not been documented since 1924. Hemorrhagic fever

viruses are primarily bloodborne pathogens, but none occur naturally

in the U.S. Any suspected importation of these infectious agents are

thoroughly investigated by the Public Health Service.

B. Guidelines for Determining Exposure to an Airborne Infectious

Disease Listed in Part II

Under section 300ff-82, if it is determined that a patient has

an airborne infectious disease, the medical facility must notify the

Designated Officer of the EREs who transported the patient as soon

as practicable but not later than 48 hours after the determination

has been made.

C. Guidelines for Determining Exposure to a Bloodborne or Other

Infectious Disease Listed in Part II

1. Under section 300ff-83(a), an ERE may submit a request for a

determination whether he or she was exposed to an infectious

disease.

2. Upon receipt of such a request from an ERE, under section

300ff-83 (b) and (c) the Designated Officer must:

a. Collect facts relating to the circumstances under which the

ERE may have been exposed to an infectious disease, and

b. Evaluate the facts and determine if the ERE would have been

exposed to an infectious disease (see Part III.A.).

c. If the Designated Officer determines that the ERE may have

been exposed to an infectious disease, he or she must send to the

medical facility to which the patient was transported a signed

written request, along with the facts collected, for a determination

of whether the ERE was exposed to a listed disease.

3. When a medical facility receives such a request, under

section 300ff-83(d), it must:

a. Determine if there is sufficient information in the request

to identify the patient suspected of having an infectious disease

(see Part III).\7\

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\7\Note however, that per section 300ff-88, ``this subpart may

not, with respect to victims of emergencies, be construed to

authorize or require a medical facility to test any such victim for

any infectious disease.''

---------------------------------------------------------------------------

b. If the medical facility can identify the patient in question,

medical records should be reviewed for:

(i) Results of tests diagnostic for any of the diseases listed

in Part II.

(ii) Signs or symptoms compatible with any of the diseases

listed in Part II.

c. If it is determined that the patient is infected with any of

the diseases listed in Part II, the medical facility must review the

information sent with the request to determine if the ERE was

exposed.

(i) In determining whether the ERE was exposed, the medical

facility should consider whether, based on the facts, the ERE was in

circumstances in which there is a significant risk of becoming

infected with the etiologic agent for the disease with which the

patient is infected;

(ii) In determining whether there was a significant risk of the

ERE becoming infected with the etiologic agent for the disease with

which the patient is infected, the medical facility should consider:

(a) The nature of the risk (how the disease is transmitted),

(b) The duration of the risk (how long is the carrier

infectious),

(c) The severity of the risk (what is the potential harm to

others), and

(d) The probabilities the disease will be transmitted and will

cause varying degrees of harm.

(iii) Under section 300ff-83(e), if a determination of exposure

is made, the medical facility must notify the Designated Officer in

writing as soon as practicable, but not later than 48 hours after

receiving the request, that the ERE was exposed to a listed disease.

(iv) If the information provided by the Designated Officer is

insufficient to make a determination, the medical facility must so

notify the Designated Officer in writing as soon as practicable but

not later than 48 hours after receiving the request.

(v) Under section 300ff-83(g), if the Designated Officer

receives notice of insufficient information, he or she may request

the public health officer for the community in which the medical

facility is located to evaluate the request and the medical

facility's response. The public health officer must then evaluate

the request and the medical facility's response and report his or

her findings to the Designated Officer as soon as practicable but

not later than 48 hours after receiving the request.

(a) If the public health officer finds the information provided

is sufficient to make a determination of exposure, he or she must

submit the request to the medical facility.

(b) If the public health officer finds the information provided

was insufficient to make a determination of exposure, he or she must

advise the Designated Officer about collecting more information. If

sufficient facts are subsequently collected by the Designated

Officer, the public health officer must resubmit the request to the

medical facility.

D. References

In making determinations or evaluations described in this Part,

the Designated Officer, the medical facility, or the public health

officer may use standard medical references or the latest edition of

The Control of Communicable Diseases in Man. Additional references

are listed in Addendum C.

Part IV. Implementation of the Law

A. By April 20, 1994, State public health officers must have

selected persons to serve as Designated Officers of EREs for each

employer of EREs in their States. In the selection of Designated

Officers, the State public health officer shall give preference to

individuals who are trained in the provision of health care or the

control of infectious diseases (section 300ff-86).

B. By April 20, 1994, medical facilities must have in place

procedures for:

1. Notifying Designated Officers within 48 hours of any

instances in which it is known that a patient who has been

transported to the medical facility is infected with an airborne

disease listed in Part II (section 300ff-82(a) and (b)).

2. Responding within 48 hours to written requests from

Designated Officers for determination of possible exposure to

diseases listed in Part II (section 300ff-83(e)).

C. By April 20, 1994, ERE employers must have in place

procedures by which EREs can make requests of Designated Officers

and procedures by which the Designated Officers would make

appropriate disposition of such requests (section 300ff-83(a)).

D. By April 20, 1994, local health agencies must have in place

procedures for handling requests for evaluations from Designated

Officers (section 300ff-83(g)).

E. By April 20, 1994, the Secretary of Health and Human Services

will:

1. Send copies of the list of potentially life-threatening

diseases and the exposure guidelines to State public health officers

requesting appropriate distribution (section 300ff-81(c)(1)).

2. Make copies of the list and guidelines available to the

public (section 300ff-81(c)(2)).

3. Have in place procedures for receiving and handling

allegations of violations of the exposure notification process

(section 300ff-89(b)).

Addendum A

Background--Text of Sections 2681-2690 of the PHS Act as amended by

Pub. L. 101-381 (42 U.S.C. 300ff-81 to 300ff-90. References are to

Title 42 U.S.C.). (Published for informational purposes only)

SUBPART II--Notifications of Possible Exposure to Infectious Diseases

SEC. 300ff-81. Infectious Diseases and Circumstances Relevant to

Notification Requirements.

(a) In General.--Not later than 180 days after the date of the

enactment of the Ryan White Comprehensive AIDS Resources Emergency

Act of 1990, the Secretary shall complete the development of--

(1) A list of potentially life-threatening infectious diseases

to which emergency response employees may be exposed in responding

to emergencies;

(2) Guidelines describing the circumstances in which such

employees may be exposed to such diseases, taking into account the

conditions under which emergency response is provided; and

(3) Guidelines describing the manner in which medical facilities

should make determinations for purposes of Section 300ff-83(d).

(b) Specification of Airborne Infectious Diseases.--The list

developed by the Secretary under subsection (a)(1) shall include a

specification of those infectious diseases on the list that are

routinely transmitted through airborne or aerosolized means.

(c) Dissemination.--The Secretary shall--

(1) Transmit to the state public health officers copies of the

list and guidelines developed by the Secretary under subsection (a)

with the request that the officers disseminate such copies as

appropriate throughout the states; and

(2) Make such copies available to the public.

Sec. 300ff-82. Routine Notifications With Respect to Airborne

Infectious Diseases in Victims Assisted.

(a) Routine Notification of Designated Officer.

(1) Determination by Treating Facility.--If a victim of an

emergency is transported by emergency response employees to a

medical facility and the medical facility makes a determination that

the victim has an airborne infectious disease, the medical facility

shall notify the designated officer of the emergency response

employees who transported the victim to the medical facility of the

determination.

(2) Determination by Facility Ascertaining Cause of Death.--If a

victim of an emergency is transported by emergency response

employees to a medical facility, the medical facility ascertaining

the cause of death shall notify the designated officer of the

emergency response employees who transported the victim to the

initial medical facility of any determination by the medical

facility that the victim had an airborne infectious disease.

(b) Requirement of Prompt Notification.-- With respect to a

determination described in paragraph (1) or (2), the notification

required in each of such paragraphs shall be made as soon as is

practicable, but not later than 48 hours after the determination is

made.

Sec. 300ff-83. Request for Notifications with Respect to Victims

Assisted.

(a) Initiation of Process by Employee.--If an emergency response

employee believes that the employee may have been exposed to an

infectious disease by a victim of an emergency who was transported

to a medical facility as a result of the emergency, and if the

employee attended, treated, assisted, or transported the victim

pursuant to the emergency, then the designated officer of the

employee shall, upon the request of the employee, carry out the

duties described in subsection (b) regarding a determination of

whether the employee may have been exposed to an infectious disease

by the victim.

(b) Initial Determination by Designated Officer.--The duties

referred to in subsection (a) are that--

(1) The designated officer involved collect the facts relating

to the circumstances under which, for purposes of subsection (a),

the employee involved may have been exposed to an infectious

disease; and

(2) the designated officer evaluate such facts and make a

determination of whether, if the victim involved had any infectious

disease included on the list issued under paragraph (1) of Section

300ff-81(a), the employee would have been exposed to the disease

under such facts, as indicated by the guidelines issued under

paragraph (2) of such Section.

(c) Submission of Request to Medical Facility.--

(1) In General.--If a designated officer makes a determination

under subsection (b)(2) that an emergency response employee may have

been exposed to an infectious disease, the designated officer shall

submit to the medical facility to which the victim involved was

transported a request for a response under subsection (d) regarding

the victim of the emergency involved.

(2) Form of Request.--A request under paragraph (1) shall be in

writing and be signed by the designated officer involved, and shall

contain a statement of the facts collected pursuant to subsection

(b)(1).

(d) Evaluation and Response Regarding Request to Medical

Facility.--

(1) In General.--If a medical facility receives a request under

subsection (c), the medical facility shall evaluate the facts

submitted in the request and make a determination of whether, on the

basis of the medical information possessed by the facility regarding

the victim involved, the emergency response employee was exposed to

an infectious disease included on the list issued under paragraph

(1) of Section 300ff-81(a), as indicated by the guidelines issued

under paragraph (2) of such Section.

(2) Notification of Exposure.--If a medical facility makes a

determination under paragraph (1) that the emergency response

employee involved has been exposed to an infectious disease, the

medical facility shall, in writing, notify the designated officer

who submitted the request under subsection (c) of the determination.

(3) Finding of no Exposure.--If a medical facility makes a

determination under paragraph (1) that the emergency response

employee involved has not been exposed to an infectious disease, the

medical facility shall, in writing, inform the designated officer

who submitted the request under subsection (c) of the determination.

(4) Insufficient Information.--(A) If a medical facility finds

in evaluating facts for purposes of paragraph (1) that the facts are

insufficient to make the determination described in such paragraph,

the medical facility shall, in writing, inform the designated

officer who submitted the request under subsection (c) of the

insufficiency of the facts.

(B)(i) If a medical facility finds in making a determination

under paragraph (1) that the facility possesses no information on

whether the victim involved has an infectious disease included on

the list under Section 2681(a), the medical facility shall, in

writing, inform the designated officer who submitted the request

under subsection (c) of the insufficiency of such medical

information.

(ii) If after making a response under clause (i) a medical

facility determines that the victim involved has an infectious

disease, the medical facility shall make the determination described

in paragraph (1) and provide the applicable response specified in

this subsection.

(e) Time for Making Response.--After receiving a request under

subsection (c) (including any such request resubmitted under

subsection (g)(2)), a medical facility shall make the applicable

response specified in subsection (d) as soon as is practicable, but

not later that 48 hours after receiving the request.

(f) Death of Victim of Emergency.--

(1) Facility Ascertaining Cause of Death.--If a victim described

in subsection (a) dies at or before reaching the medical facility

involved, and the medical facility receives a request under

subsection (c), the medical facility shall provide a copy of the

request to the medical facility ascertaining the cause of death of

the victim, if such facility is a different medical facility than

the facility that received the original request.

(2) Responsibility of Facility.--Upon the receipt of a copy of a

request for purposes of paragraph (1), the duties otherwise

established in this subpart regarding medical facilities shall apply

to the medical facility ascertaining the cause of death of the

victim in the same manner and to the same extent as such duties

apply to the medical facility originally receiving the request.

(g) Assistance of Public Health Officer.--

(1) Evaluation of Response of Medical Facility Regarding

Insufficient Facts.--

(A) In the case of a request under subsection (c) to which a

medical facility has made the response specified in subsection

(d)(4)(A) regarding the insufficiency of facts, the public health

officer for the community in which the medical facility is located

shall evaluate the request and the response, if the designated

officer involved submits such documents to the officer with the

request that the officer make such an evaluation.

(B) As soon as is practicable after a public health officer

receives a request under paragraph (1), but not later than 48 hours

after receipt of the request, the public health officer shall

complete the evaluation required in such paragraph and inform the

designated officer of the results of the evaluation.

(2) Finding of Evaluation.--

(A) If an evaluation under paragraph (1)(A) indicates that the

facts provided to the medical facility pursuant to subsection (c)

were sufficient for purposes of determinations under subsection

(d)(1)--

(i) The public health officer shall, on behalf of the designated

officer involved, resubmit the request to the medical facility; and

(ii) The medical facility shall provide to the designated

officer the applicable response specified in subsection (d).

(B) If an evaluation under paragraph (1)(A) indicates that the

facts provided in the request to the medical facility were

insufficient for purposes of determinations specified in subsection

(c)--

(i) The public health officer shall provide advice to the

designated officer regarding the collection and description of

appropriate facts; and

(ii) If sufficient facts are obtained by the designated

officer--

(I) the public health officer shall, on behalf of the designated

officer involved, resubmit the request to the medical facility; and

(II) The medical facility shall provide to the designated

officer the appropriate response under subsection (c).

Sec. 300ff-84. Procedures for Notification of Exposure.

(a) Contents of Notification to Officer.--In making a

notification required under section 300ff-82 or section 300ff-

83(d)(2), a medical facility shall provide--

(1) The name of the infectious disease involved; and

(2) The date on which the victim of the emergency involved was

transported by emergency response employees to the medical facility

involved.

(b) Manner of Notification.--If a notification under Section

300ff-82 or Section 300ff-82(d)(2) [sic] is mailed or otherwise

indirectly made--

(1) The medical facility sending the notification shall, upon

sending the notification, inform the designated officer to whom the

notification is sent of the fact that the notification has been

sent; and

(2) Such designated officer shall, not later than 10 days after

being informed by the medical facility that the notification has

been sent, inform such medical facility whether the designated

officer has received the notification.

Sec. 300ff-85. Notification of Employee.

(a) In General.--After receiving a notification for purposes of

section 300ff-82 or 300ff-83(d)(2), a designated officer of

emergency response employees shall, to the extent practicable,

immediately notify each of such employees who--

(1) Responded to the emergency involved; and

(2) As indicated by guidelines developed by the Secretary, may

have been exposed to an infectious disease.

(b) Certain Contents of Notification to Employee.--A

notification under this subsection to an emergency response employee

shall inform the employee of--

(1) The fact that the employee may have been exposed to an

infectious disease and the name of the disease involved;

(2) Any action by the employee that, as indicated by guidelines

developed by the Secretary, is medically appropriate; and

(3) If medically appropriate under such criteria, the date of

such emergency.

(c) Responses Other Than Notification of Exposure.--After

receiving a response under paragraph (3) or (4) of subsection (d) of

section 300ff-83, or a response under subsection (g)(1) of such

section, the designated officer for the employee shall, to the

extent practicable, immediately inform the employee of the response.

Sec. 300ff-86. Selection of Designated Officers.

(a) In General.--For the purposes of receiving notifications and

responses and making requests under this subpart on behalf of

emergency response employees, the public health officer of each

state shall designate 1 official or officer of each employer of

emergency response employees in the state.

(b) Preference in Making Designations.--In making the

designations required in subsection (a), a public health officer

shall give preference to individuals who are trained in the

provision of health care or in the control of infectious diseases.

SEC. 300ff-87. Limitations With Respect to Duties of Medical

Facilities.

The duties established in this subpart for a medical facility--

(1) Shall apply only to medical information possessed by the

facility during the period in which the facility is treating the

victim for conditions arising from the emergency, or during the 60-

day period beginning on the date on which the victim is transported

by emergency response employees to the facility, whichever period

expires first; and

(2) Shall not apply to any extent after the expiration of the

30-day period beginning on the expiration of the applicable period

referred to in paragraph (1), except that such duties shall apply

with respect to any request under section 300ff-83(c) received by a

medical facility before the expiration of such 30-day period.

Sec. 300ff-88. Rules of Construction.

(a) Liability of Medical Facilities and Designated Officers.--

This subpart may not be construed to authorize any cause of action

for damages or any civil penalty against any medical facility, or

any designated officer, for failure to comply with the duties

established in this subpart.

(b) Testing.--This subpart may not, with respect to victims of

emergencies, be construed to authorize or require a medical facility

to test any such victim for any infectious disease.

(c) Confidentiality.--This subpart may not be construed to

authorize or require any medical facility, any designated officer of

emergency response employees, or any such employee, to disclose

identifying information with respect to a victim of an emergency or

with respect to any emergency response employee.

(d) Failure to Provide Emergency Services.--This subpart may not

be construed to authorize any emergency response employee to fail to

respond, or to deny services, to any victim of an emergency.

Sec. 300ff-89. Injunctions Regarding Violation of Prohibition.

(a) In General.--The Secretary may, in any court of competent

jurisdiction, commence a civil action for the purpose of obtaining

temporary or permanent injunctive relief with respect to any

violation of this subpart.

(b) Facilitation of Information on Violations.--The Secretary

shall establish an administrative process for encouraging emergency

response employees to provide information to the Secretary regarding

violations of this subpart. As appropriate, the Secretary shall

investigate alleged such violations and seek appropriate injunctive

relief.

Sec. 300ff-90. Applicability of Subpart.

This subpart shall not apply in a state if the chief executive

officer of the state certifies to the Secretary that the law of the

state is in substantial compliance with this subpart.

Effective Date.--Sections 300ff-80 and 300ff-81 of part E of

title XXVI of the Public Health Service Act, as added by subsection

(a) of this section, shall take effect upon the date of the

enactment of this Act. Such part shall otherwise take effect upon

the expiration of the 30-day period beginning on the date on which

the Secretary issues guidelines under section 300ff-81(a).

(See 300ff-80 Note in Title 42 of the United States Code)

Addendum B

Excerpts Concerning Hepatitis B Vaccination

Guidelines for Prevention of Transmission of Human

Immunodeficiency Virus and Hepatitis B Virus to Health-Care and

Public-Safety Workers. Morbidity and Mortality Weekly Report 1989;

38 (supplement no. S-6).

Emergency medical workers have an increased risk for hepatitis B

infection . . . The degree of risk correlates with the frequency and

extent of blood exposure during the conduct of work activities. A

few studies are available concerning risk of HBV infection for other

groups of public-safety workers (law-enforcement personnel and

correctional-facility workers), but reports that have been published

do not document any increased risk for HBV infection . . .

Nevertheless, in occupational settings in which workers may be

routinely exposed to blood or other body fluids as described below,

an increased risk for occupational acquisition of HBV infection must

be assumed to be present.

Occupational Safety and Health Administration's Occupational

Exposure to Bloodborne Pathogens Standard, 29 CFR Part 1910.1030.

(f) Hepatitis B vaccination and post-exposure evaluation and

follow-up--

(1) General.

(i) The employer shall make available the hepatitis B vaccine

and vaccination series to all employees who have occupational

exposure . . .

(ii) The employer shall ensure that . . . the hepatitis B

vaccine and vaccination series and post-exposure evaluation and

follow-up, including prophylaxis, are:

(A) Made available at no cost to the employee.

(3) Post-exposure Evaluation and Followup. Following a report of

an exposure incident, the employer shall make immediately available

to the exposed employee a confidential medical evaluation and

follow-up, including at least the following elements:

(v) Counseling.

Addendum C

References

General:

Benenson AS (ed). Control of communicable diseases in man.

Washington, D.C.: The American Public Health Association, 15th

edition, 1990.

For hepatitis B and human immunodeficiency virus:

CDC. Guidelines for prevention of transmission of human

immunodeficiency virus and hepatitis B virus to health-care and

public-safety workers. MMWR 1989; 38 (supplement no. S-6).

Occupational Safety and Health Administration. Occupational

exposure to bloodborne pathogens: final rule. 29 CFR Part 1910.1030.

Federal Register, December 6, 1991.

For tuberculosis:

American Thoracic Society/Centers for Disease Control.

Diagnostic standards and classification of tuberculosis. Amer Rev

Resp Dis 1009;142:725-35.

American Thoracic Society/Centers for Disease Control. Control

of tuberculosis. Amer Rev Resp Dis. 1983;128:336-342.

[FR Doc. 94-6492 Filed 3-18-94; 8:45 am]

BILLING CODE 4163-18-P