[Federal Register Volume 76, Number 212 (Wednesday, November 2, 2011)]
[Notices]
[Pages 67736-67743]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-28234]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket NIOSH-219]
Implementation of Section 2695 (42 U.S.C. 300ff-131) of Public
Law 111-87: Infectious Diseases and Circumstances Relevant to
Notification Requirements
AGENCY: Centers for Disease Control and Prevention, Department of
Health and Human Services.
ACTION: Final notice.
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SUMMARY: The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub.
L. 111-87) addresses notification procedures for medical facilities and
state public health officers and their designated officers regarding
exposure of emergency response employees (EREs) to potentially life-
threatening infectious diseases. The Secretary of Health and Human
Services (Secretary) has delegated authority to the Director of the
Centers for Disease Control and Prevention (CDC) to issue a list of
potentially life-threatening infectious diseases, including emerging
infectious diseases, to which EREs may be exposed in responding to
emergencies (including a specification of those infectious diseases
that are routinely transmitted through airborne or aerosolized means);
guidelines describing circumstances in which employees may be exposed
to these diseases; and guidelines describing the manner in which
medical facilities should make determinations about exposures. On
December 13, 2010, CDC invited comment on a draft list of covered
infectious diseases and both sets of guidelines (75 FR 77642). In
consideration of the comments received, this notice sets forth CDC's
final list of diseases, 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.
DATES: The list of diseases and guidelines in this notice will be
effective December 2, 2011.
FOR FURTHER INFORMATION CONTACT: James Spahr, Centers for Disease
Control and Prevention, National Institute for Occupational Safety and
Health, 1600 Clifton Road, NE., M/S E20, Atlanta, GA 30333, telephone
(404) 498-6185.
SUPPLEMENTARY INFORMATION:
Preamble Table of Contents
Introduction
Response to Comments
Implementation of Section 2695 (42 U.S.C. 300ff-131): Infectious
Diseases and Circumstances Relevant to Notification Requirements
Contents
Definitions
Part I. List of Potentially Life-Threatening Infectious Diseases to
Which Emergency Response Employees May Be Exposed
Part II. Guidelines Describing the Circumstances in Which Emergency
Response Employees May Be Exposed to Such Diseases
Part III. Guidelines Describing the Manner in Which Medical
Facilities Should Make Determinations for Purposes of Section
2695B(d) [42 U.S.C. 300ff-133(d)]
Introduction
The Ryan White HIV/AIDS Treatment Extension Act of 2009 (Pub. L.
111-87) amended the Public Health Service Act (PHS Act, 42 U.S.C. 201-
300ii), including the addition of a Part G to Title XXVI, which
addresses notification procedures and requirements for medical
facilities and state public health officers and their designated
officers regarding exposure of EREs to potentially life-threatening
infectious diseases. (See Title XXVI, Part G of the PHS Act, codified
as amended at 42 U.S.C. 300ff-131 to 300ff-140.)
For purposes of these notification requirements, sec. 2695 [42
U.S.C. 300ff-131] requires the Secretary to develop and disseminate:
1. A list of potentially life-threatening infectious diseases,
including emerging infectious diseases, to which EREs may be exposed in
responding to emergencies (including a specification of those
infectious diseases on the list that are routinely transmitted through
airborne or aerosolized means);
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 sec. 2695B(d) [Evaluation
and Response Regarding Request to Medical Facility, 42 U.S.C. 300ff-
133(d)].
On July 7, 2010, the Secretary issued a PHS Act Delegation of
Authority (Delegation of Authority), which assigned to the Director of
CDC the authority vested in the Secretary of HHS (Secretary) under sec.
2695 of Title XXVI (42 U.S.C. 300ff-131) ``as it pertains to the
functions assigned to the [CDC]'' (75 FR 40842, July 14, 2010). On
December 13, 2010, CDC invited comment on a draft list of covered
infectious diseases and two sets of guidelines developed pursuant to
this Delegation of Authority and 42 U.S.C. 300ff-131 through a general
notice and request for comments published in the Federal Register (75
FR 77642).
Response to Comments
In response to the December 2010 notice, CDC received a total of 83
comments from 22 individuals and/or organizations. The comments are
addressed below.
Emergency Response Employees (EREs)
Comment: CDC received two comments regarding EREs. One commenter
wanted to make it clear that police were included among the group of
people considered EREs. The other commenter wanted there to be a
specification that EREs included volunteer and paid emergency medical
services.
CDC response: ``Emergency response employee'' is not defined in the
PHS Act, and CDC's authority for purposes of this notice is limited to
those duties set out in the Delegation of Authority (75 FR 40842). The
duties of an individual considered an ERE are described in 42 U.S.C.
300ff-133(a):
[[Page 67737]]
[i]f 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.
Non-compliance
Comment: CDC received one comment regarding non-compliance. The
commenter noted that there was no mention of an administrative contact
person or a process regarding non-compliance.
CDC response: The PHS Act addresses this issue in section 2695H [42
U.S.C. 300ff-139], which is outside the scope of this notice covering
the Secretary's duties under sec. 2695 [42 U.S.C. 300ff-131]. The
December 13, 2010, Federal Register notice was limited to those duties
assigned to CDC through the Secretary's Delegation of Authority (75 FR
40842).
Designated officers
Comment: CDC received one comment regarding designated officers.
The commenter noted that the designated officer position needs to be
better developed.
CDC response: The PHS Act does not provide a definition of
``designated officer,'' except that 42 U.S.C. 300ff-136 provides for
selection of such officer by the public health officer of each state.
The December 13, 2010, Federal Register notice was limited to those
duties assigned to CDC through the Secretary's Delegation of Authority
(75 FR 40842). Development of the designated officer position is beyond
the scope of the Delegation and this notice.
Definitions
The December 13, 2010, general notice and request for comments
provided definitions only where such were necessary for clarification
of CDC's approach to developing the disease list and guidelines as
assigned to CDC through the Secretary's Delegation of Authority (75 FR
40842). CDC received five comments regarding definitions. One commenter
approved of the definitions.
Comment: Two commenters wanted to either use the word
``communicable'' instead of ``infectious'' or to add the word
``communicable'' in front of ``infectious.''
CDC response: To ensure consistency in interpretation of terms used
in the PHS Act and in the guidelines, CDC is mirroring the Act's
language in its guidelines to the extent feasible. Title XXVI, Part G
of the PHS Act refers only to the word ``infectious'' and not to the
word ``communicable.'' Furthermore, the ability of the infectious
diseases included in the draft to be transmitted from person to person
is addressed in their specification as ``transmitted by contact or body
fluid exposures,'' ``transmitted through aerosolized airborne means,''
or ``transmitted through aerosolized droplet means.'' In addition, Part
III, ``Guidelines Describing the Manner in Which Medical Facilities
Should Make Determinations for Purpose of Section 2695B(d) [42 U.S.C.
300ff-133(d)],'' in several places requires consideration of
``infectious disease that was possibly contagious at the time of the
potential exposure incident.'' Therefore the requested wording change
was not made.
Comment: Two commenters requested that the word ``exposed'' be
redefined as ``any contact direct or indirect with a person in which
there is a risk of transmission of an infectious agent to an ERE.''
CDC response: CDC did not redefine ``exposed.'' The existing
definition is clear and there was concern that the word ``contact''
could lead to misinterpretations.
List of Potentially Life-Threatening Infectious Diseases (Part I)
Under sec. 2695 of Title XXVI (42 U.S.C. 300ff-131), CDC, through
the Delegation of Authority by the Secretary of HHS, must issue a list
of potentially life-threatening infectious diseases, including emerging
infectious diseases, to which EREs may be exposed in responding to
emergencies (including a specification of those infectious diseases
that are routinely transmitted through airborne or aerosolized means).
CDC received 45 comments regarding its proposed disease list.
CDC received a number of positive comments in support of the
proposed disease list. For example, one commenter was pleased to see
the addition of hepatitis C to the disease list. Another commenter
supported finalization of the disease list. Two commenters stated that
they agreed with the list of Potentially Life-Threatening Infectious
Diseases: Routinely Transmitted by Contact or Body Fluid Exposures and
the list of Potentially Life-Threatening Infectious Diseases: Routinely
Transmitted Through Aerosolized Airborne Means. Two commenters
appreciated the language in the document permitting amendments to the
list in the future as warranted by new scientific information or
emerging diseases.
Comment: Two commenters felt that there should not be two separate
lists, one listing diseases with aerosolized airborne transmission and
the other listing diseases with aerosolized droplet transmission. They
requested there be a single specification for the list of life-
threatening infectious diseases that identifies disease routinely
transmitted through airborne or aerosolized means. In contrast, others
supported this approach. One commenter ``agrees with these definitions
[regarding aerosolized airborne and aerosolized droplet transmission
and the corresponding lists] and appreciates the thoroughness and
clarity in which they are written,'' and stated that ``[t]his will
permit our members to implement the revised requirements with accuracy
and consistency.'' Two other commenters provided very similar
supportive comments.
CDC response: CDC holds that having two separate lists most
accurately represents the epidemiology of the diseases on the
respective lists and mirrors usual infection control terminology, which
will facilitate comprehension and optimal implementation of the Act.
Therefore, the two separate lists (aerosolized airborne transmission
and aerosolized droplet transmission) have been retained.
Commenters also asked CDC to consider amending the disease list by
adding or removing conditions.
Comment: One commenter recommended that all multi-drug-resistant
organisms (MDROs) be added to the disease list to establish
documentation and surveillance for these organisms. Five other
commenters specifically wanted methicillin-resistant Staphylococcus
aureus (MRSA) and other resistant organisms [for example E. coli ST131
and vancomycin-resistant enterococci (VRE)] to be added to the disease
list.
CDC response: Because documentation and surveillance activities are
beyond the scope of 42 U.S.C. 300ff-131, the addition of MDROs for the
purpose of documentation and surveillance to the disease list is not
warranted. CDC's authority for purposes of this final notice is limited
to those duties assigned to CDC through the Secretary's Delegation of
Authority (75 FR 40842).
Regarding the addition of MRSA and other resistant organisms (ST131
and VRE) for the purposes of notification, exposure alone without
clinical infection would not necessitate any type
[[Page 67738]]
of screening or prophylactic treatment.\1\ MRSA, in particular, has
become common and contemporary treatment of clinical conditions such as
wound infections or cellulitis associated with abscesses, carbuncles,
or furuncles routinely covers for MRSA until culture results allow for
the narrowing of antibiotic coverage.\2\ Therefore, CDC has not added
MRSA, ST131, VRE, or MDROs in general to the list of diseases.
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\1\ Liu C, et al. Clinical practice guidelines by the Infectious
Diseases Society of America for the treatment of methicillin-
resistant Staphylococcus aureus infections in adults and children.
Infectious Disease Society of America Guidelines. January 4, 2011.
http://cid.oxfordjournals.org/content/early/2011/01/04/cid.ciq146.full.pdf+html. Accessed July 14, 2011.
\2\ Liu C, et al. Clinical practice guidelines by the Infectious
Diseases Society of America for the treatment of methicillin-
resistant Staphylococcus aureus Infections in adults and children.
Infectious Disease Society of America Guidelines. January 4, 2011.
http://cid.oxfordjournals.org/content/early/2011/01/04/cid.ciq146.full.pdf+html. Accessed July 14, 2011.
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Comment: Five commenters wanted anthrax to be added to the disease
list.
CDC response: Anthrax remains an endemic public health threat
through annual epizootics in certain areas of the United States.
Cutaneous anthrax can be transmitted human to human via drainage from
lesions and is potentially fatal if left untreated; \3\ therefore,
cutaneous anthrax has been added to the list of Potentially Life-
Threatening Infectious Diseases: Routinely Transmitted by Contact or
Body Fluid Exposures. Inhalation and gastrointestinal anthrax are not
contagious from human to human and are not included in this list; they
are, however, addressed in a newly added list of Potentially Life-
Threatening Infectious Diseases Caused by Agents Potentially Used for
Bioterrorism or Biological Warfare.
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\3\ Gold H. Anthrax: a report of 117 cases. AMA Arch Int Med
1955;96:387-96.
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Comment: One commenter requested that syphilis be added to the
disease list.
CDC response: While the transmission of syphilis via accidental
needlestick injury may be a theoretical concern, there is only one case
report of its occurrence in the medical literature, and even in that
case, it is not clear whether active infection was due to a needlestick
injury. Syphilis due to needlestick injury does not pose a significant
public health risk to health care workers, and syphilis has not been
added to the list.
Comment: Eight commenters desired that seasonal influenza and/or
novel influenza be added to the disease list.
CDC response: CDC recognizes that influenza infections are
potentially life-threatening. Therefore, CDC has expanded the influenza
viruses included on the list of Potentially Life-Threatening Infectious
Diseases: Routinely Transmitted Through Aerosolized Droplet Means to
broaden them beyond just avian influenza A viruses, but still avoid
overburdening the reporting system. To achieve this, CDC has modified
the list to specify novel influenza A viruses, as defined by the
Council of State and Territorial Epidemiologists (CSTE).\4\ This
specification includes avian influenza and adds other influenza A
strains of animal origin and other new or unique reassortments.
Regarding over-burdening the reporting system, sec. 2695G(e) [42 U.S.C.
300ff-138(e)] states:
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\4\ Council of State and Territorial Epidemiologists. Novel
influenza A virus infections: 2010 Case Definition. CSTE Position
Statement Number: 09-ID-43. http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/novel_influenzaA.htm. Accessed July 18,
2011.
In any case in which the Secretary determines that, wholly or
partially as a result of a public health emergency that has been
determined pursuant to section 319(a), individuals or public or
private entities are unable to comply with the requirements of this
part, the Secretary may, not withstanding any other provision of
law, temporarily suspend, in whole or in part, the requirements of
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this part as the circumstances reasonably require.
Comment: Eight commenters suggested that pertussis be added to the
disease list.
CDC response: CDC recognizes that pertussis is a highly
communicable disease and is potentially life-threatening. Pertussis has
been associated with significant adult morbidity.\5\ Additionally, an
exposed and subsequently infected ERE might carry this highly
contagious disease home to young children, and pertussis is associated
with an increased number of fatalities in the very young.\6\ Therefore,
CDC has added pertussis to the list of Potentially Life-Threatening
Infectious Diseases: Routinely Transmitted Through Aerosolized Droplet
Means.
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\5\ De Serres G, et al. Morbidity of pertussis in adolescents
and adults. J Infect Dis 2000;182:174-9.
\6\ CDC. Pertussis--United States, 2001--2003. MMWR
2005;54:1283-6.
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Comment: One commenter noted that bioterrorist agents were not
specifically mentioned in the disease list.
CDC response: The Select Agents list maintained by HHS \7\ lists
biological agents that have the potential to pose a severe threat to
human health and that may be used or adapted for bioterrorist attacks.
Those agents on the list that are routinely transmitted human to human
are already listed in Part I ``List of Potentially Life-Threatening
Infectious Diseases to Which EREs Might be Exposed.'' CDC recognizes
that the other agents on the Select Agents list would not typically
exhibit human-to-human transmission or be considered contagious
threats. However, in the setting of potential intentional modification
to artificially increase transmissibility or lethality and deployment
as bioweapons (potentially in quantities far greater than would
naturally be encountered), atypical pathways of transmission may occur.
In this case, EREs may be exposed by entering contaminated environments
to care for victims and by exposure to contaminated individuals from
those environments. Thus, CDC has added to the definition of exposed
(``or, in the case of a select agent, from a surface or environment
contaminated by the agent to an ERE.'') and created the disease list
category Potentially Life-Threatening Infectious Diseases Caused by
Agents Potentially Used for Bioterrorism or Biological Warfare. This
disease list category includes diseases caused by any transmissible
agent included in the HHS Select Agents List including those that are
not routinely transmitted human to human but may be transmitted via
exposure to contaminated environments.\8\
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\7\ 42 CFR 73.3, 73.4.
\8\ Note: 42 CFR 73 specifies special reporting requirements for
Select Agents independent of these guidelines.
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Comment: One commenter requested rabies be removed from the disease
list or that CDC add an explanation of its presence on the list.
CDC response: Rabies is an almost universally fatal viral disease
that has no reliable treatment; therefore, if an exposure to the rabies
virus has occurred, the best hope for prevention of the disease is
timely post-exposure immunization (i.e., rabies vaccine with or without
Human Rabies Immunoglobulin). Rabies virus is present in the saliva,
nervous tissue, and spinal fluid of humans with the disease, and it is
recommended protocol that a contact investigation be conducted and
recommendations for any necessary post-exposure immunization be made
any time there has been a diagnosis of rabies in a human patient.\9\
Thus, a brief explanation has been added regarding rabies exposure, and
CDC will retain rabies on the list of Potentially Life-Threatening
Infectious Diseases:
[[Page 67739]]
Routinely Transmitted by Contact or Body Fluid Exposures.
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\9\ CDC. Human Rabies Prevention--United States, 2008:
Recommendations of the Advisory Committee on Immunization Practices.
MMWR 2008;57:1-26,28.
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Comment: Two commenters recommended that certain diseases such as
SARS-CoV, smallpox, avian influenza, and aerosolizable spores (i.e.,
anthrax) be listed on a separate list rather than on the main list.
CDC response: CDC appreciates this comment. Accordingly, anthrax
(except for the cutaneous manifestation) and smallpox (Variola virus)
have been placed in the disease list category Potentially Life-
Threatening Infectious Diseases Caused by Agents Potentially Used for
Bioterrorism or Biological Warfare. SARS-CoV and avian influenza (now
included as a ``novel influenza'') will remain under Potentially Life-
Threatening Infectious Diseases: Routinely Transmitted Through
Aerosolized Droplet Means because this accurately reflects their mode
of transmission.
Guidelines Describing the Circumstances in Which Employees May Be
Exposed (Part II).
In this final notice, ``exposed'' is defined as ``to be in
circumstances in which there is recognized risk for transmission of an
infectious agent from a human source to an ERE \10\ or, in the case of
a Select Agent, from a surface or environment contaminated by the agent
to an ERE.'' See discussion of the inclusion of Select Agents, above.
CDC received three comments regarding this section.
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\10\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 23, 2010.
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One commenter supported the way that Part I ``List of Potentially
Life-threatening Infectious Diseases to Which Emergency Response
Employees May Be Exposed'' clearly outlined the various methods of
disease transmission (contact or body fluid exposures, aerosolized
airborne, and aerosolized droplet) that are utilized in determining
risk of exposure. The other two commenters made substantive requests.
Comment: One commenter requested that aerosolized airborne and
aerosolized droplet means of transmission be addressed separately in
Part II ``Guidelines Describing the Circumstances in Which Such
Employees May Be Exposed to Such Diseases'' as they were in Part I.
CDC response: CDC determined that there was benefit in the current
approach to discussing aerosolized airborne and aerosolized droplet
transmission in the same section in Part II, limiting redundancy by
providing language common to the two modes of transmission only once.
Comment: The final commenter requested that CDC provide more
information about exposures, but did not specify what additional
information was desired.
CDC response: There was not enough specificity provided with this
comment for CDC to formulate a response. Additionally, CDC believes
that the current content of the exposures description is sufficient.
Guidelines Describing the Manner in Which Medical Facilities Should
Make Determinations (Part III)
Section 2695B(d) [42 U.S.C. 300ff-133(d)] specifies that medical
facilities shall evaluate the facts submitted in an ERE's request to
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 pursuant to sec. 2695(a)(1) [42 U.S.C.
300ff-131(a)(1)] and sets certain parameters on these responses. CDC
received six comments regarding medical facilities.
Two commenters were supportive of the medical facility guidelines.
One supported making the proposed guidelines final. The other was in
agreement with the proposed criteria for making determination of
exposure when responding to appropriate requests by an employer; the
individual felt such interaction would result in the best
determination.
Comment: Three commenters did not feel comfortable with the medical
facilities' authority to determine exposure. One commenter felt that
the guidance should not allow a medical facility to overrule the
designated officer's determination that an exposure had occurred. Two
commenters noted that Part III ``Guidelines Describing the Manner in
Which Medical Facilities Should Make Determination for Purposes of
Section 2695B(d) [42 U.S.C. 300ff-133(d)]'' appears to require medical
facilities to conduct a second exposure evaluation, and they felt that
the role of a medical facility should be solely to determine if a
patient had a disease transmissible by aerosols, and if so, to provide
information to the designated officer who would notify all potentially
exposed EREs. One commenter stated that medical facility management and
exposure guidelines are not adequate and will not work well.
CDC response: CDC notes that the role and responsibilities of
medical facilities are specified in some detail in the statute in sec.
2695B(d), (e), (f) [42 U.S.C. 300ff-133(d), (e), (f)]. In addition,
sec. 2695B(g) [42 U.S.C. 300ff-133(g)] specifies the role of the public
health officer in resolving differences of opinion between designated
officers and medical facilities.
Notification
Under sec. 2695B(c)(2) [42 U.S.C. 300ff-133(c)(2)], a request for
notification with respect to victims assisted shall be in writing and
signed by the designated officer involved, and shall contain a
statement of the facts collected pursuant to subsection (b)(1).
Additionally, under sec. 2695B(e) [42 U.S.C. 300ff-133(e)], after
receiving a request, a medical facility must make the applicable
response as soon as is practicable, but not later than 48 hours after
receiving the request. CDC received nine comments regarding
notification.
Comment: Three commenters felt that the requirement for a written
request was not practical. Of these commenters, two advocated for the
use of modern technology allowing requests to be in a documented verbal
or electronic form followed by a written communication. Three
commenters felt that the 48-hour time frame for response by the medical
facility is too long and that this time frame may unnecessarily
restrict or delay notifications to EREs. One commenter felt there was a
problem with medical facilities taking responsibility for notifying
exposed EREs of lab results that were available a day or two after the
victim arrived at the facility.
CDC response: Processes specified in the PHS Act cannot be altered
through the guidelines published in this final notice. Moreover, the
scope of this final notice is limited to those duties assigned to CDC
through the Secretary's Delegation of Authority (75 FR 40842).
Comment: One commenter requested additional clarification or
emphasis that the statute requires medical facilities to notify EREs of
possible exposure to TB and that the facilities notify the designated
officers of the ERE agencies regarding the newly added airborne and
droplet transmitted diseases.
CDC response: CDC has placed TB on the list of Potentially Life-
Threatening Infectious Diseases: Routinely Transmitted Through
Aerosolized Airborne Means; thus it will require routine notification.
Additionally, sec. 2695(c) of Title XXVI [42 U.S.C. 300ff-131(c)]
addresses dissemination by requiring that CDC, as delegated by the
Secretary of HHS, shall transmit to State public health officers copies
of the list and guidelines it developed with the request that the
officers disseminate
[[Page 67740]]
such copies as appropriate throughout the State and make such copies
available to the public.
Comment: One commenter felt that non-transporting emergency
response employees should be included in notifications.
CDC response: As previously noted, ``emergency response employee''
is not defined in the PHS Act and CDC's authority for purposes of this
notice is limited to those duties set out in the Delegation of
Authority (75 FR 40842). The duties of an individual considered an ERE
are described in 42 U.S.C. 300ff-133(a) as having ``attended, treated,
assisted, or transported the victim pursuant to the emergency.''
HIPAA
CDC received three comments regarding the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), which provides
confidentiality for patients' protected health information, including
health conditions, treatments, or payment records. In general, HIPAA
rules would apply to EREs and medical facilities caring for the victims
of emergencies.
Comment: One commenter recommended the addition of a statement
directing ERE companies to provide appropriate requests to medical
facilities while also adhering to HIPAA rules in the process.
CDC response: CDC, in consultation with the HHS Office for Civil
Rights, notes that the HIPAA rules regarding privacy of individually
identifiable health information apply to HIPAA covered entities and, to
some extent, to their business associates. Those ERE companies that are
HIPAA covered entities or business associates must adhere to the
relevant HIPAA rules. While ERE companies that are neither HIPAA
covered entities nor their business associates are not subject to
HIPAA, we expect that the designated officers of all ERE companies will
only request relevant information of medical facilities; i.e., whether
there was sufficient information to determine whether the emergency
response employee involved had been exposed and, if so, what
determination did the facility make. What information can be requested
and reported can be found in sec. 2695C(a)(1), (2) [42 U.S.C. 300ff-
134(a)(1), (2)] and sec. 2695D(a)(1), (2) and (b)(1)-(3) [42 U.S.C.
300ff-135(a)(1), (2) and (b)(1)-(3)]. Section 2695G(c) [42 U.S.C.
300ff-138(c)] states that ``[t]his part 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.''
Comment: Two commenters recommended a clear statement that
notification of source patient test results or other information is not
a HIPAA violation.
CDC response: CDC, in consultation with the HHS Office for Civil
Rights, notes that under the HIPAA Privacy Rule, if a law requires the
disclosure of individually identifiable health information, a covered
entity (such as a medical facility) may comply with such statute
provided that the disclosure complies with and is limited to the
relevant requirements of such law. Public Law 111-87 requires medical
facilities that make determinations as to whether EREs have been
exposed to an infectious disease to notify the designated officer who
submitted the request. If the determination is that the employee has
been exposed, the medical facility shall provide the name of the
infectious disease involved and the date on which the victim of the
emergency was transported by EREs to the facility. Other than this
information, Public Law 111-87 does not authorize medical facilities to
disclose identifying information with respect to either a victim of an
emergency or an ERE. A medical facility would not violate HIPAA by
complying with this requirement of the PHS Act.
Patient Testing
CDC received four comments regarding testing victims of emergencies
for potentially life-threatening infectious diseases. Results of such
tests are generally needed for medical facilities to make definitive
determinations about potential ERE exposures.
Comment: Three commenters noted that there are state laws allowing
for the testing of victims if an ERE can document an exposure; one of
these three commenters recommended it be stated that State and local
laws be used when they are more expansive than the Federal law.
CDC response: CDC has not added that specific statement to this
final notice, because it is outside the scope of this notice, which is
limited to those duties assigned to CDC through the Secretary's
Delegation of Authority. However, Section 2695G(f) [42 U.S.C. 300ff-
138(f)] states that ``[n]othing in this part shall be construed to
limit the application of State or local laws that require the provision
of data to public health authorities.''
Comment: One commenter requested that CDC strongly recommend
patient testing.
CDC response: Patient testing is not authorized under sec. 2695G(b)
[42 U.S.C. 300ff-138(b)], which specifically states that ``this part
may not, with respect to victims of emergencies, be construed to
authorize or require a medical facility to test any such victim for an
infectious disease.''
General
CDC received 7 general comments not focused on a specific part of
the December 13, 2010, Federal Register notice.
Comment: Two commenters stated that the Act is important and urged
CDC to move as quickly as possible to implement.
CDC response: CDC agrees and is working toward that end.
Comment: Two commenters recommended that more research is needed
regarding how to protect EREs, and encouraged the National Institute
for Occupational Safety and Health (NIOSH) to conduct more research.
CDC response: CDC agrees that this remains an important area of
investigation.
Comment: One commenter recommended that Title XXVI, Part G of the
PHS Act be a standalone Public Law.
CDC response: The requested action is outside the scope of this
final notice and Delegation of Authority.
Comment: One commenter recommended that CDC/NIOSH facilitate a
structured process to engage key stakeholders in development of any
regulation and guidance materials related to the Ryan White HIV/AIDS
Treatment Extension Act.
CDC response: CDC appreciates this comment and agrees that
transparency and stakeholder involvement are extremely important. This
is why CDC published its draft guidance in the Federal Register and
requested public comments to assist in development of the final
guidance. Even after this final notice is issued, CDC will encourage
stakeholders to continue to provide comments and intends to establish a
Web site to facilitate ongoing communication.
Comment: One commenter stated that he or she supports and would be
willing to participate in pre-rabies vaccination for wildlife
rehabilitators and others who volunteer or are employed working with
animals.
CDC response: Although CDC appreciates this response, this topic is
outside the scope of this notice and the Delegation of Authority.
[[Page 67741]]
Final Notice
For the reasons discussed in the preamble, CDC amends
Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87:
Infectious Diseases and Circumstances Relevant to Notification
Requirements as follows:
Implementation of Section 2695 (42 U.S.C. 300ff-131) Public Law 111-87:
Infectious Diseases and Circumstances Relevant to Notification
Requirements
The Ryan White HIV/AIDS Treatment Extension Act of 2009 \11\ (Pub.
L. 111-87) amended the Public Health Service Act (PHS Act, 42 U.S.C.
201-300ii) and addresses notification procedures and requirements for
medical facilities and state public health officers and their
designated officers regarding exposure of emergency response employees
(EREs) to potentially life-threatening infectious diseases.\12\ (See
Title XXVI, Part G of the PHS Act, codified as amended at 42 U.S.C.
300ff-131 to 300ff-140). This document 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, as required by the Act. The final list of
diseases and guidelines incorporate comments received by CDC on a draft
list and guidelines (75 FR 77642, December 13, 2010).
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\11\ The Ryan White Act (Pub. L. 111-87) amended the Public
Health Service Act (PHS Act, 42 U.S.C. 201-300ii), including the
addition of a Part G to Title XXVI.
\12\ See Title XXVI, Part G of the PHS Act, codified as amended
at 42 U.S.C. 300ff-131 to 300ff-140.
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Contents
Definitions
Part I. List of Potentially Life-Threatening Infectious
Diseases to Which Emergency Response Employees May Be Exposed.
Part II. Guidelines Describing the Circumstances in Which
Emergency Response Employees May Be Exposed to Such Diseases.
Part III. Guidelines Describing the Manner in Which
Medical Facilities Should Make Determinations for Purposes of Section
2695B(d) [42 U.S.C. 300ff-133(d)].
Definitions
The following definitions are used in the list of diseases and
guidelines:
Aerosol means tiny particles or droplets suspended in air. These
range in diameter from about 0.001 to 100 [mu]m.\13\
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\13\ Baron P. Generation and Behavior of Airborne Particles
(Aerosols). PowerPoint Presentation. U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, Division of Applied
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 22, 2011.
Baron PA, Willeke K, eds. Aerosol measurement: Principles,
Techniques, and Applications. Second edition. New York: John Wiley &
Sons, Inc. 2001.
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Aerosolized transmission means person-to-person transmission of an
infectious agent through the air by an aerosol. See ``aerosolized
airborne transmission'' and ``aerosolized droplet transmission.''
Aerosolized airborne transmission means person-to-person
transmission of an infectious agent by an aerosol of small particles
able to remain airborne for long periods of time. These are able to
transmit diseases on air currents over long distances, to cause
prolonged airspace contamination, and to be inhaled into the trachea
and lung.\14\
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\14\ Baron P. Generation and Behavior of Airborne Particles
(Aerosols). PowerPoint Presentation. U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, Division of Applied
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 22, 2011.
Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
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Aerosolized droplet transmission means person-to-person
transmission of an infectious agent by large particles only able to
remain airborne for short periods of time. These generally transmit
diseases through the air over short distances (approximately 6 feet),
do not cause prolonged airspace contamination, and are too large to be
inhaled into the trachea and lung.\15\
---------------------------------------------------------------------------
\15\ Baron P. Generation and Behavior of Airborne Particles
(Aerosols). PowerPoint Presentation. U.S. Department of Health and
Human Services, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, Division of Applied
Technology. http://www.cdc.gov/niosh/topics/aerosols/pdfs/Aerosol_101.pdf. Accessed September 22, 2011.
Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
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Contact or body fluid transmission means person-to-person
transmission of an infectious agent through direct or indirect contact
with an infected person's blood or other body fluids.\16\
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\16\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
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Exposed means to be in circumstances in which there is recognized
risk for transmission of an infectious agent from a human source to an
ERE \17\ or, in the case of a Select Agent, from a surface or
environment contaminated by the agent to an ERE.
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\17\ Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings. http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf. Accessed September 22, 2011.
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Potentially life-threatening infectious disease means an infectious
disease to which EREs may be exposed and that has reasonable potential
to cause death or fetal mortality in either healthy EREs or in EREs who
are able to work but take medications or are living with conditions
that might impair host defense mechanisms.
Part I. List of Potentially Life-Threatening Infectious Diseases to
Which Emergency Response Employees May Be Exposed
The List of Potentially Life-Threatening Infectious Diseases to
Which Emergency Response Employees May Be Exposed is divided into four
sections: Diseases routinely transmitted by contact or body fluid
exposures, those routinely transmitted through aerosolized airborne
means, those routinely transmitted through aerosolized droplet means,
and those caused by agents potentially used for bioterrorism or
biological warfare. Diseases often have multiple transmission pathways.
However, for purposes of this classification, diseases routinely
transmitted via the aerosol airborne or aerosol droplet routes are so
classified, even if other routes, such as contact transmission, also
occur. CDC will continue to monitor the scientific literature on these
and other infectious diseases. In the event that CDC determines that a
newly emerged infectious disease fits criteria for inclusion in the
list of potentially life-threatening infectious diseases required by
the Ryan White HIV/AIDS Treatment Extension Act of 2009, CDC will amend
the list and add the disease.
A. Potentially Life-Threatening Infectious Diseases: Routinely
Transmitted by Contact or Body Fluid Exposures
Anthrax, cutaneous (Bacillus anthracis)
Hepatitis B (HBV)
Hepatitis C (HCV)
[[Page 67742]]
Human immunodeficiency virus (HIV)
Rabies (Rabies virus)
Vaccinia (Vaccinia virus)
Viral hemorrhagic fevers (Lassa, Marburg, Ebola, Crimean-
Congo, and other viruses yet to be identified) \18\
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\18\ For most viral hemorrhagic fevers (VHFs), routine
transmission is limited to transmission from a zoonotic reservoir or
direct contact with an infected person (e.g. Ebola virus, Marburg
virus) or through arthropod-borne transmission (Rift Valley fever,
Crimean-Congo hemorrhagic fever). For a small number of VHF viruses,
transmission may occur through droplet transmission (e.g. Nipah
virus), however prolonged close contact is likely necessary. Aerosol
transmission does not occur in natural (non-laboratory) settings.
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B. Potentially Life-Threatening Infectious Diseases: Routinely
Transmitted Through Aerosolized Airborne Means
These diseases are included within ``those infectious diseases on
the list that are routinely transmitted through airborne or aerosolized
means.'' \19\
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\19\ Section 2695(b) [42 U.S.C. 300ff-131(b)].
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Measles (Rubeola virus)
Tuberculosis (Mycobacterium tuberculosis)--infectious
pulmonary or laryngeal disease; or extrapulmonary (draining lesion)
Varicella disease (Varicella zoster virus)--chickenpox,
disseminated zoster
C. Potentially Life-Threatening Infectious Diseases: Routinely
Transmitted Through Aerosolized Droplet Means
These diseases are included within ``those infectious diseases on
the list that are routinely transmitted through airborne or aerosolized
means.'' \20\
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\20\ Section 2695(b) [42 U.S.C. 300ff-131(b)].
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Diphtheria (Corynebacterium diphtheriae)
Novel influenza A viruses as defined by the Council of
State and Territorial Epidemiologists (CSTE) \21\
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\21\ Council of State and Territorial Epidemiologists, Position
Statement Number: 09-ID-43. Available at http://www.cdc.gov/osels/ph_surveillance/nndss/casedef/novel_influenzaA.htm (Accessed July
18, 2011).
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Meningococcal disease (Neisseria meningitidis)
Mumps (Mumps virus)
Pertussis (Bordetella pertussis)
Plague, pneumonic (Yersinia pestis)
Rubella (German measles; Rubella virus)
SARS-CoV
D. Potentially Life-Threatening Infectious Diseases Caused by Agents
Potentially Used for Bioterrorism or Biological Warfare
These diseases include those caused by any transmissible agent
included in the HHS Select Agents List.\22\ Many are not routinely
transmitted human to human but may be transmitted via exposure to
contaminated environments. (See the special note in Part II.C for
further explanation.) The HHS Select Agents List is updated regularly
and can be found on the National Select Agent Registry Web site: http://www.selectagent.gov/.
---------------------------------------------------------------------------
\22\ 42 CFR 73.3, 73.4.
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Part II. Guidelines Describing the Circumstances in Which Emergency
Response Employees May Be Exposed to Such Diseases
A. Exposure to Diseases Routinely Transmitted Through Contact or Body
Fluid Exposures
Contact transmission is divided into two subgroups: Direct and
indirect. Direct transmission occurs when microorganisms are
transferred from an infected person to another person without a
contaminated intermediate object or person. Indirect transmission
involves the transfer of an infectious agent through a contaminated
intermediate object or person.
Contact with blood and other body fluids may transmit the
bloodborne pathogens HIV, HBV, and HCV. When EREs have contact
circumstances in which differentiation between fluid types is
difficult, if not impossible, all body fluids are considered
potentially hazardous. In the Occupational Safety and Health
Administration (OSHA) 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.'' \23\
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\23\ 29 CFR 1910.1030.
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Occupational exposure to cutaneous anthrax would include exposure
of an ERE's nonintact skin or mucous membrane to drainage from a
cutaneous anthrax lesion; percutaneous injuries with sharp instruments
potentially contaminated with lesion drainage should also be considered
exposures. Contact with blood or other bodily fluids is not thought to
pose a significant risk for anthrax transmission. Occupational exposure
to rabies would include exposure of an ERE's wound, nonintact skin, or
mucous membrane to saliva, nerve tissue, or cerebral spinal fluid from
an infected individual. Percutaneous injuries with contaminated sharp
instruments should be considered exposures because of potential contact
with infected nervous tissue. Intact skin contact with infectious
materials or contact only with blood, urine, or feces is not thought to
pose a significant risk for rabies transmission. Occupational exposures
of concern to vaccinia would include contact of mucous membranes (eyes,
nose, mouth, etc.) or non-intact skin with drainage from a vaccinia
vaccination site or other mucopurulent lesion caused by vaccinia
infection.
B. Exposure to Diseases Routinely Transmitted Through Airborne or
Aerosolized Means
Occupational exposure to pathogens routinely transmitted through
aerosolized airborne transmission may occur when an ERE shares air
space with a contagious individual who has an infectious disease caused
by these pathogens. Such an individual can expel small droplets into
the air through activities such as coughing, sneezing and talking.
After water evaporates from the airborne droplets, the dried out
remnants can remain airborne as droplet nuclei. Occupational exposure
to pathogens routinely transmitted through aerosolized droplet
transmission may occur when an ERE comes within about 6 feet of a
contagious individual who has an infectious disease caused by these
pathogens and who creates large respiratory droplets through activities
such as sneezing, coughing, and talking.
C. Special Note on Exposure to Diseases Transmitted by Agents
Potentially Used for Bioterrorism or Biological Warfare
The Select Agents list \24\ maintained by HHS, lists biological
agents and
[[Page 67743]]
toxins that have the potential to pose a severe threat to human health
and that may be used for or adapted for bioterrorist attacks. There are
special reporting requirements for Select Agents, as detailed in 42 CFR
part 73. Those agents included on the HHS Select Agents List that are
routinely transmitted person to person and for which natural
transmission remains a significant concern are categorized in the
``List of Potentially Life-Threatening Infectious Diseases to Which
Emergency Response Employees May be Exposed,'' Part I above, according
to their modes of transmission. The remaining agents on the Select
Agent List would not typically exhibit human-to-human transmission or
be considered contemporary contagious threats. However, in the setting
of potential intentional modification to artificially increase
transmissibility and/or lethality (``weaponization'') and deployment as
bio-weapons (potentially in quantities far greater than would naturally
be encountered), atypical pathways of transmission may occur. In this
case, EREs may be exposed by entering contaminated environments to care
for victims and by exposure to contaminated individuals from those
environments.
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\24\ Notwithstanding any notification procedures specified here,
all reporting requirements that are required under 42 CFR part 73
remain applicable. The HHS Select Agents list is updated regularly
and can be found on the National Select Agent Registry Web site:
http://www.selectagent.gov/. Agents on the HHS select agents list at
the time of publication of this notice include the following:
42 CFR 73.3:
Botulinum neurotoxin producing species of Clostridium;
Cercopithecine herpesvirus 1 (Herpes B virus); Coccidioides
posadasii/Coccidioides immitis; Coxiella burnetii; Crimean-Congo
haemorrhagic fever virus; Eastern Equine Encephalitis virus; Ebola
viruses; Francisella tularensis; Lassa fever virus; Marburg virus;
Monkeypox virus; Reconstructed replication competent forms of the
1918 pandemic influenza virus containing any portion of the coding
regions of all eight gene segments (Reconstructed 1918 Influenza
virus); Rickettsia prowazekii; Rickettsia rickettsii; South American
Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal,
Guanarito); Tick-borne encephalitis complex (flavi) viruses (Central
European Tick-borne encephalitis, Far Eastern Tick-borne
encephalitis [Russian Spring and Summer encephalitis, Kyasanur
Forest disease, Omsk Hemorrhagic Fever]); Variola major virus
(Smallpox virus) and Variola minor virus (Alastrim); Yersinia
pestis.
42 CFR 73.4:
Bacillus anthracis; Brucella abortus; Brucella melitensis;
Brucella suis; Burkholderia mallei (formerly Pseudomonas mallei);
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei);
Hendra virus; Nipah virus; Rift Valley fever virus; Venezuelan
Equine Encephalitis virus.
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Part III. Guidelines Describing the Manner in Which Medical Facilities
Should Make Determinations for Purposes of Section 2695B(d) [42 U.S.C.
300ff-133(d)]
Section 2695B(d) [42 U.S.C. 300ff-133(d)] specifies that medical
facilities must respond to appropriate requests by making
determinations about whether EREs have been exposed to infectious
diseases included on the list issued pursuant to sec. 2695(a)(1) [42
U.S.C. 300ff-131(a)(1)]. A medical facility has access to two types of
information related to a potential exposure incident to use in making a
determination. First, the request submitted to the medical facility
contains a ``statement of the facts collected'' about the ERE's
potential exposure incident.\25\ Information about infectious disease
transmission provided in relevant CDC guidance documents \26\ or in
current medical literature should be considered in assessing whether
there is a realistic possibility that the exposure incident described
in the statement of the facts could potentially transmit an infectious
disease included on the list issued pursuant to sec. 2695(a)(1) [42
U.S.C. 300ff-131(a)(1)].
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\25\ Section 2695B [42 U.S.C. 300ff-133].
\26\ For example:
Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the
Healthcare Infection Control Practices Advisory Committee. 2007
Guideline for Isolation Precautions: Preventing Transmission of
Infectious Agents in Healthcare Settings.
CDC. Updated U.S. Public Health Service Guidelines for the
Management of Occupational Exposures to HIV and Recommendations for
Postexposure Prophylaxis. MMWR 2005;54 (No. RR-9):1-17.
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Second, the medical facility possesses medical information about
the victim of an emergency transported and/or treated by the ERE. This
is the medical information that the medical facility would normally
obtain according to its usual standards of care to diagnose or treat
the victim, since the Act does not require special testing in response
to a request for a determination. As stated in sec. 2695G(b) [42 U.S.C.
300ff-138(b)], ``this part 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.''
Information about the potential exposure incident and medical
information about the victim should be used in the following manner to
make one of the four possible determinations as required by sec.
2695B(d) [42 U.S.C. 300ff-133(d)]:
(1) The ERE involved has been exposed to an infectious disease
included on the list:
--Facts provided in the request document a realistic possibility that
an exposure incident occurred with potential for transmitting a listed
infectious disease from the victim of an emergency to the involved ERE;
and
--The medical facility possesses sufficient medical information
allowing it to determine that the victim of an emergency treated and/or
transported by the involved ERE had a listed infectious disease that
was possibly contagious at the time of the potential exposure incident.
(2) The ERE involved has not been exposed to an infectious disease
included on the list:
--Facts provided in the request rule out a realistic possibility that
an exposure incident occurred with potential for transmitting a listed
infectious disease from the victim of an emergency to the involved ERE;
or
--The medical facility possesses sufficient medical information
allowing it to determine that the victim of an emergency treated and/or
transported by the involved ERE did not have a listed infectious
disease that was possibly contagious at the time of the potential
exposure incident.
(3) The medical facility possesses no information on whether the
victim involved has an infectious disease included on the list:
--The medical facility lacks sufficient medical information allowing it
to determine whether the victim of an emergency treated and/or
transported by the involved ERE had, or did not have, a listed
infectious disease at the time of the potential exposure incident.
--If the medical facility subsequently acquires sufficient medical
information allowing it to determine that the victim of an emergency
treated and/or transported by the involved ERE had a listed infectious
disease that was possibly contagious at the time of the potential
exposure incident, then it should revise its determination to reflect
the new information.
(4) The facts submitted in the request are insufficient to make the
determination about whether the ERE was exposed to an infectious
disease included on the list:
--Facts provided in the request insufficiently document the exposure
incident, making it impossible to determine if there was a realistic
possibility that an exposure incident occurred with potential for
transmitting an infectious disease included on the list issued pursuant
to Section 2695(a)(1) [42 U.S.C. 300ff-131(a)(1)] from the victim of an
emergency to the involved ERE.
Dated: October 26, 2011.
James W. Stephens,
Director, Office of Science Quality, Office of the Associate Director
for Science, Centers for Disease Control and Prevention.
[FR Doc. 2011-28234 Filed 11-1-11; 8:45 am]
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