[Federal Register Volume 80, Number 226 (Tuesday, November 24, 2015)]
[Proposed Rules]
[Pages 73153-73156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29790]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Bureau of Prisons
28 CFR Part 549
[BOP-1169-P]
RIN 1120-AB69
Infectious Disease Management: Voluntary and Involuntary Testing
AGENCY: Bureau of Prisons, Justice.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In this document, the Bureau of Prisons proposes two minor
revisions to its regulations on the management of infectious diseases.
One change would remove the requirement for HIV pre-test counseling for
inmates, because the counseling requirement has become an obstacle to
necessary testing. Inmates testing positive for HIV will continue to
receive HIV post-test counseling. The second change would alter
language regarding tuberculosis (TB) testing to clarify that it is
testing for the TB infection, but not ``skin testing.'' This would
account for advances in medical technology that allow for newer testing
methods.
DATES: Written comments must be submitted on or before January 25,
2016.
ADDRESSES: Rules Unit, Office of General Counsel, Bureau of Prisons,
320 First Street NW., Washington, DC 20534.
FOR FURTHER INFORMATION CONTACT: Rules Unit, Office of General Counsel,
Bureau of Prisons, phone (202) 353-8214.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record and made available for public inspection online at
www.regulations.gov. Such information
[[Page 73154]]
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online, you must include the phrase ``PERSONAL IDENTIFYING
INFORMATION'' in the first paragraph of your comment. You must also
locate all the personal identifying information you do not want posted
online in the first paragraph of your comment and identify what
information you want redacted.
If you want to submit confidential business information as part of
your comment but do not want it to be posted online, you must include
the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the first paragraph
of your comment. You must also prominently identify confidential
business information to be redacted within the comment. If a comment
contains so much confidential business information that it cannot be
effectively redacted, all or part of that comment may not be posted on
www.regulations.gov.
Personal identifying information identified and located as set
forth above will be placed in the agency's public docket file, but not
posted online. Confidential business information identified and located
as set forth above will not be placed in the public docket file. If you
wish to inspect the agency's public docket file in person by
appointment, please see the ``For Further Information Contact''
paragraph.
SUPPLEMENTARY INFORMATION: The Bureau proposes two minor revisions to
its regulations on the infectious disease management program (28 CFR,
part 549, subpart A). One change would remove the requirement for HIV
pre-test counseling for inmates, because the counseling requirement has
become an obstacle to necessary testing. Inmates testing positive for
HIV will continue to receive HIV post-test counseling. The second
change would alter language regarding tuberculosis (TB) testing to
clarify that it is testing for the TB infection, but not ``skin
testing.'' This would account for advances in medical technology that
allow for newer testing methods.
Clarifications to inmate information procedures. 28 CFR
549.12(a)(1) currently states that the ``Bureau tests inmates who have
sentences of six months or more if health services staff determine,
taking into consideration the risk as defined by the Centers for
Disease Control Guidelines, that the inmate is at risk for HIV
infection.'' We propose to make minor clarifying changes to this
language to make it clear that such inmates will be informed orally or
in writing that HIV testing will be performed unless they decline
testing. This would be a minor change to be consistent with CDC
Guidelines, which state that ``HIV screening is recommended for
patients in all health-care settings after the patient is notified that
testing will be performed unless the patient declines (opt-out
screening)''. In light of the CDC Guidelines, we propose to change the
regulation language to clarify that HIV screening is recommended for
all inmates because risk factors are present in the correctional
health-care setting. The language as it currently exists in the
regulation does not make it clear that inmates will be so notified,
although this has already been the Bureau's longstanding procedure
during Admission and Orientation of inmates.
Eliminating the requirement for HIV pre-test counseling and HIV
post-test counseling for HIV-negative inmates. In 28 CFR 549.12
(Testing), subparagraph (a)(5) currently states that ``Inmates being
tested for HIV will receive pre- and post-test counseling, regardless
of the test results.'' We propose altering this subparagraph to read as
follows: ``Inmates testing positive for HIV will receive post-test
counseling.'' This change would eliminate the requirement that the
Bureau provide pre-test counseling for inmates and post-test counseling
for HIV-negative inmates. We propose these changes to bring our
requirements in conformance with those recommended by the Center for
Disease Control (CDC) in their report entitled ``Revised
Recommendations for HIV Testing of Adults, Adolescents, and Pregnant
Women in Health Care Settings'' (2006, MMWR 55(RR14); 1-17); http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
The CDC set forth guidelines in 1994 for counseling and testing
persons with high-risk behaviors which specified prevention (pre-test)
counseling to develop specific prevention goals and strategies for each
person (client-centered counseling). However, in 2003, CDC introduced
an initiative entitled ``Advancing HIV Prevention: New Strategies for a
Changing Epidemic''. One key point of this initiative was to make HIV
testing a routine part of medical care on the same voluntary basis as
other diagnostic and screening tests. In its technical guidance, CDC
acknowledged that although prevention (pre-test) counseling is
desirable for all persons at risk for HIV, such counseling might not be
appropriate or feasible in all settings. Because time constraints
caused some providers to perceive requirements for prevention
counseling and written informed consent as a barrier to uniform
testing, the initiative advocated streamlined approaches. The CDC found
that although targeted testing programs, like the Bureau's infection
disease management program, were implemented in acute-care settings and
nearly two thirds of patients in these settings accept testing; risk
assessment and prevention (pre-test) counseling are time-consuming, so
only a limited proportion of eligible patients can be tested.
There are significant benefits of HIV testing for inmates because
treatment for HIV can be initiated promptly preventing serious
complications and death. The CDC has found that requirements for pre-
test prevention counseling pose a barrier to testing and therefore CDC
recommends that an ``opt-out'' testing protocol be utilized, in which
persons are informed that they will be tested unless they choose not to
be tested. Specifically CDC recommends that:
HIV screening is recommended for patients in all health-
care settings after the patient is notified that testing will be
performed unless the patient declines (opt-out screening).
Separate written consent for HIV testing should not be
required; general consent for medical care should be considered
sufficient to encompass consent for HIV testing.
Prevention counseling should not be required with HIV
diagnostic testing or as part of HIV screening programs in health-care
settings.
``Revised Recommendations for HIV Testing of Adults, Adolescents, and
Pregnant Women in Health Care Settings'' (2006, MMWR 55(RR14); 1-17);
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm.
In addition to the above, the Bureau also notes that eliminating
the pre-test counseling requirement would save Bureau staff
approximately 20 minutes per counseling session. Since the Bureau
strives to test all inmates, the time savings this would permit are
substantial. We therefore propose to delete the requirement for pre-
test counseling in order to conform with CDC guidelines and to remove
this barrier to testing as many inmates as possible.
We also propose to remove the requirement for post-HIV-test
counseling for inmates who have tested negative for HIV. Those testing
positive will continue to receive post-test
[[Page 73155]]
counseling. Those testing negative, however, have no need for further
counseling, but may ask questions of Health Services staff as needed.
Eliminating the post-test counseling requirement for inmates testing
HIV negative would also save 20 minutes per counseling session per
inmate. Again, the time saving is quite substantial, considering that
more than 98% of HIV tests performed are negative results.
Changing terminology to clarify that TB testing is no longer ``skin
testing.'' In 28 CFR 549.12(b)(4), we currently state that ``[i]f an
inmate refuses skin testing, and there is no contraindication to
tuberculin skin testing, then, institution medical staff will test the
inmate involuntarily.'' (Emphasis added.) We now proposed to alter this
sentence to read as follows: ``If an inmate refuses testing for TB
infection, and there is no contraindication to testing, then
institutional medical staff will test the inmate involuntarily.'' The
only alteration we make in this language is to clarify that
Tuberculosis testing is no longer ``skin testing.''
The Bureau currently primarily uses the tuberculin skin test for
testing for latent TB infection. However, a new type of test for TB
infection has become available, a blood test called the Interferon
Gamma Release Assay (IGRA). In the next 5 to 10 years it is anticipated
that blood tests for TB infection will replace the tuberculin skin
test. These tests appear to be at least as accurate as the skin test
and have the benefit of requiring only one interaction with an inmate
to draw blood (rather than place the skin test and reading it 2 to 3
days later). Using this type of test would eliminate the need for a
second health care visit to conduct the test, as no ``reading'' would
be required, which would result in great time savings to Bureau staff.
Once more, we make this change to bring the Bureau into conformance
with CDC guidelines. In 2010, the CDC issued ``Updated Guidelines for
Using Interferon Gamma Release Assays to Detect Mycobacterium
tuberculosis infection--United States, 2010'' (MMWR 59(RR-5) 1-13;
http://www.cdc.gov/mmwr/pdf/rr/rr5905.pdf. In this report, the CDC
states that ``[b]efore 2001, the tuberculin skin test (TST) was the
only practical and commercially available immunologic test for TB
infection approved in the United States.''
However, several risks are associated with the use of TSTs:
Difficulty with the very specific administration needed, unreliable
patient return to the health-care provider for the test reading, and
inaccuracies and biases existing in reading the TSTs, such as false-
positives. IGRAs, however, assess the presence of specific tuberculosis
proteins, and therefore offer improved test specificity compared with
TSTs.
For this reason, the CDC has recommended increasing use of IGRAs.
Although skin testing may still be used, it will not be used
exclusively, so we propose to update our regulatory language to allow
for the possibility of other kinds of testing for TB infection.
Other changes for clarity:
We also propose to make minor changes to Sec. 549.12(a)(2),
Exposure incidents, to clarify that the current language stating that
the Bureau will test ``when there is a well-founded reason to believe
that the inmate may have transmitted the HIV infection'' means the
following: The Bureau tests an inmate, regardless of the length of
sentence or pretrial status, when there is a well-founded reason to
believe that the inmate has been the source of a percutaneous or mucous
membrane blood exposure, via an altercation or accident or other means
to Bureau employees, other non-inmates who are lawfully present in a
Bureau institution, or other inmates, regardless of whether the
exposure was intentional or unintentional. Exposure incident testing
does not require the inmate's consent. This language more accurately
reflects the intention of the regulation.
Executive Order 12866
This proposed regulation has been drafted and reviewed in
accordance with Executive Order 12866, ``Regulatory Planning and
Review'', section 1(b), Principles of Regulation. The Director, Bureau
of Prisons has determined that this proposed regulation is a
``significant regulatory action'' under Executive Order 12866, section
3(f), and accordingly this proposed regulation has been reviewed by the
Office of Management and Budget.
Executive Order 13132
This proposed regulation will not have substantial direct effects
on the States, on the relationship between the national government and
the States, or on distribution of power and responsibilities among the
various levels of government. Therefore, under Executive Order 13132,
we determine that this proposed regulation does not have sufficient
federalism implications to warrant the preparation of a Federalism
Assessment.
Regulatory Flexibility Act
The Director of the Bureau of Prisons, under the Regulatory
Flexibility Act (5 U.S.C. 605(b)), reviewed this proposed regulation
and certifies that it will not have a significant economic impact upon
a substantial number of small entities for the following reasons: This
proposed regulation pertains to the correctional management of inmates
committed to the custody of the Attorney General or the Director of the
Bureau of Prisons. Its economic impact is limited to the Bureau's
appropriated funds.
Unfunded Mandates Reform Act of 1995
This proposed regulation will not result in the expenditure by
State, local and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more in any one year, and it will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This proposed rule is not a major rule as defined by section 251 of
the Small Business Regulatory Enforcement Fairness Act of 1996, 5
U.S.C. 804. This proposed regulation will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects in 28 CFR Part 571
Prisoners.
Charles E. Samuels, Jr.,
Director, Bureau of Prisons.
Under rulemaking authority vested in the Attorney General in 5
U.S.C. 301; 28 U.S.C. 509, 510 and delegated to the Director, Bureau of
Prisons in 28 CFR 0.96, we proposed to amend 28 CFR part 549 as
follows.
SUBCHAPTER C--INSTITUTIONAL MANAGEMENT
PART 549--MEDICAL SERVICES
0
1. The authority citation for 28 CFR part 549 continues to read as
follows:
Authority: 5 U.S.C. 301; 10 U.S.C. 876b; 18 U.S.C. 3621, 3622,
3524, 4001, 4005, 4042, 4045, 4081, 4082 (Repealed in part as to
offenses committed on or after November 1, 1987), Chapter 313, 5006-
5024 (Repealed October 12, 1984 as to offenses committed after that
date), 5039; 28 U.S.C. 509, 510.
[[Page 73156]]
0
2. Amend Sec. 549.12 by revising paragraphs (a) and (b)(4) to read as
follows:
Sec. 549.12 Testing.
(a) Human Immunodeficiency Virus (HIV)--(1) Testing. All inmates
who have sentences of six months or more will be informed upon
admission either orally or in writing that HIV testing will be
performed unless they refuse testing. If the inmate refuses testing and
the inmate has risk factors for HIV infection as defined by the Centers
for Disease Control and Prevention, staff will provide pre-test
counseling, and if the inmate continues to refuse testing, staff may
initiate an incident report for refusing to obey an order. Any inmate
may request HIV testing during the pre-release process.
(2) Exposure incidents. The Bureau tests an inmate, regardless of
the length of sentence or pretrial status, when there is a well-founded
reason to believe that the inmate has been the source of a percutaneous
or mucous membrane blood exposure, via an altercation or accident or
other means to Bureau employees, other non-inmates who are lawfully
present in a Bureau institution, or other inmates, regardless of
whether the exposure was intentional or unintentional. Exposure
incident testing does not require the inmate's consent.
(3) Surveillance testing. The Bureau conducts HIV testing for
surveillance purposes as needed. If the inmate refuses testing, staff
will offer pre-test counseling, and if the inmate continues to refuse
testing, staff may initiate an incident report for refusing to obey an
order.
(4) Inmate request. An inmate may request to be tested. The Bureau
limits such testing to no more than one per 12-month period unless the
Bureau determines that additional testing is warranted.
(5) Counseling. Inmates testing positive for HIV will receive post-
test counseling.
(b) * * *
* * * * *
(4) An inmate who refuses TB screening may be subject to an
incident report for refusing to obey an order. If an inmate refuses
testing for TB infection, and there is no contraindication to testing,
then, institution medical staff will test the inmate involuntarily.
[FR Doc. 2015-29790 Filed 11-23-15; 8:45 am]
BILLING CODE 4410-05-P