[Federal Register Volume 60, Number 193 (Thursday, October 5, 1995)]
[Rules and Regulations]
[Pages 52278-52281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24798]
[[Page 52277]]
_______________________________________________________________________
Part III
Department of Justice
_______________________________________________________________________
Bureau of Prisons
_______________________________________________________________________
28 CFR Part 549
Infectious Diseases; Interim Rule
Federal Register / Vol. 60, No. 193 / Thursday, October 5, 1995 /
Rules and Regulations
[[Page 52278]]
DEPARTMENT OF JUSTICE
Bureau of Prisons
28 CFR Part 549
[BOP-1017-I]
RIN 1120-AA23
Infectious Diseases
AGENCY: Bureau of Prisons, Justice.
ACTION: Interim rule.
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SUMMARY: In this document, the Bureau of Prisons adopts as interim
regulations provisions for the correctional management of chronic
infectious diseases. These provisions, with minor adjustments, extend
the scope of the existing provisions for Human Immunodeficiency Virus
(HIV) programs to encompass the correctional management of other
chronic infectious diseases such as hepatitis and tuberculosis. The
intended effect of these regulations is to provide for the continued
care of inmates in the Bureau's custody and for the continued secure
and orderly operation of the institution.
DATES: Effective October 5, 1995; comments must be submitted by
December 4, 1995.
ADDRESSES: Office of General Counsel, Bureau of Prisons, HOLC Room 754,
320 First Street, NW., Washington, DC 20534.
FOR FURTHER INFORMATION CONTACT: Roy Nanovic, Office of General
Counsel, Bureau of Prisons, phone (202) 514-6655.
SUPPLEMENTARY INFORMATION: The Bureau of Prisons is adopting as interim
regulations the following procedures for the management of infectious
diseases in a correctional setting. A final rule on the management of
human immunodeficiency virus (HIV) programs (28 CFR part 549, subpart
A) was published in the Federal Register December 21, 1990 (55 FR
52826). These interim regulations represent a broadening of the
existing provisions for HIV programs to encompass the management (e.g.,
mandatory testing requirements) of other chronic infectious diseases
such as hepatitis and tuberculosis.
The existing provisions have been reorganized in order to clearly
separate requirements specific to the HIV and to the hepatitis B virus
(HBV) from requirements common to the management of other chronic
infectious diseases.
Section 549.10 has been revised to state the regulations' common
purpose of providing instruction and guidance in the management of
infectious diseases in the confined environment of a correctional
setting. The treatment and handling of routine infectious diseases
continue to be covered by medical protocols and therefore are
unaffected by the revised regulations.
The provisions in former Sec. 549.11 relating to intake screening
for HIV-infected inmates have been transferred to new Sec. 549.18(a)
and are discussed below. New Sec. 549.11 is added detailing program
administrative responsibilities.
The provisions in former Sec. 549.12 on housing have been
transferred to new Sec. 549.16 and are discussed below. New Sec. 549.12
is added to detail administrative requirements for state health
department reporting requirements and to reference further provisions
specific to chronic infectious diseases.
The provisions in former Sec. 549.13 on precautionary measures for
the use of communal implements have been removed. The Bureau believes
such measures are more suitably addressed in implementing instructions
to staff. This allows for greater flexibility in following updated
guidance on this subject from the Centers for Disease Control.
A new Sec. 549.13 is added containing provisions on medical
testing. Paragraph (a) of new Sec. 549.13 contains new provisions for
testing of inmates following a bloodborne pathogen exposure incident.
Such testing requires the written, informed consent of the inmate,
except if the test is ordered by a court with proper jurisdiction.
Under paragraph (a), an inmate may be subjected to disciplinary action
for assaultive behavior related to an exposure incident. The Bureau's
disciplinary procedures (see 28 CFR 541, subpart B) already specify
assault as a prohibited act subject to disciplinary action. The
provision in paragraph (a) is intended to clarify that an exposure
incident could involve assaultive behavior; involvement in an exposure
incident, however, does not, in and of itself, constitute grounds for
disciplinary action.
Paragraph (b) of new Sec. 549.13 summarizes the provisions
previously stated in paragraphs (a), (b), and (c) of former
Sec. 549.16. Testing provisions for HIV are also restated in new
Sec. 549.18 along with provisions for HBV and are discussed below.
Paragraph (c) of new Sec. 549.13 specifies new correctional
procedures to be used in conjunction with the medical diagnosis and
evaluation of infectious and communicable diseases. Under paragraph
(c)(1), an inmate who refuses such diagnostic procedures and
evaluations is subject to an incident report for failure to follow an
order. This requirement is intended to encourage the inmate's voluntary
cooperation with medically indicated procedures. Paragraph (c)(2)
restates medical protocols for isolation or quarantine. Paragraph
(c)(3) specifies that when isolation is not practicable, an inmate who
refuses to comply with or adhere to the diagnostic process or
evaluation shall be involuntarily evaluated or tested. The Bureau
believes that the secure and orderly operation of the institution
necessitates interim implementation of these provisions.
The provisions of former Sec. 549.14 on work assignments have been
transferred to new Sec. 549.16 and are discussed below. A new
Sec. 549.14 has been added containing training requirements for inmates
pertinent to infectious diseases. This section largely restates the
education provisions of former Sec. 549.15 which were pertinent solely
to HIV education. In addition to the broadening of subject matter
covered (i.e., infectious diseases instead of merely HIV), this section
reduces the requirements for supplementing the training given during
Admission and Orientation.
As noted above, the provisions of former Sec. 549.15 have been
incorporated in new Sec. 549.14. A new Sec. 549.15 has been added on
medical isolation and quarantining for infectious diseases which are
transmitted through casual contact. This new section adapts standard
medical protocols for use in a correctional setting.
The provisions of former Sec. 549.16 have been transferred to new
Sec. 549.18 and are discussed below. A new Sec. 549.16 is added
containing provisions on duty and housing restrictions. Paragraph (a)
of new Sec. 549.16 specifies that the Clinical Director shall assess
any inmate with an infectious disease for appropriateness for duties
and housing, and that inmates demonstrating infectious diseases which
are transmitted through casual contact shall be prohibited from
employment in any area until fully evaluated by a health care provider.
This new provision, therefore, is an administrative measure intended to
ensure that duty and housing restrictions are imposed only after
appropriate review by health care providers or as a precautionary
measure pending review. Paragraph (b), which derives from the
provisions of Sec. 549.14, specifies that inmates may be limited in
duty and housing assignments only if their disease could be transmitted
despite the use of environmental/engineering controls or personal
protective equipment, or when precautionary measures cannot be
[[Page 52279]]
implemented or are not available to prevent the transmission of the
specific disease. Reference to HIV antibody screening as a criterion
for work detail assignment has been removed. The Bureau believes that
the provisions of paragraph (b) precisely state the criteria used for
both housing and work detail assignment, and consequently there is no
need to exclude further criteria. Paragraph (c) restates the provisions
of former Sec. 549.12.
The provisions in Sec. 549.17 on confidentiality have been revised
for the purpose of indicating wider applicability to chronic infectious
diseases, to include reference to release under the Privacy Act, and to
include a prohibition against third party disclosure.
The provisions in former Sec. 549.18 have been designated as
paragraph (i) of new Sec. 549.18. As revised, new Sec. 549.18 contains
miscellaneous provisions pertaining to HIV or HBV. Paragraph (a)
restates the provisions of former Sec. 549.11 and, for the sake of
emphasis, repeats the advisory on incident reports prescribed by new
Sec. 549.13(b). Paragraph (b) restates the provisions of the
introductory text of former Sec. 549.16 (non-prescriptive language was
not restated for the sake of conciseness). Paragraphs (c) and (d)
partly restate the provisions of former Secs. 549.16(a) (1) and (2).
The remainder of Secs. 549.16(a) (1) and (2) have been restated in new
Sec. 549.13(b). Paragraph (e) revises the provisions of former
Sec. 549.16(b)(1) to limit inmate requests for voluntary HIV/HBV
antibody tests to no more than once yearly. Paragraph (f) restates the
provisions of former Sec. 549.16(b)(2). Paragraph (g) restates the
provisions of former Sec. 549.16(c). Paragraph (h) restates the
provisions of former Sec. 549.16(d) and adjusts the timeframe for
notification to the United States Probation Office. Paragraph (i)
restates the provisions of former Sec. 549.18. Paragraph (j), formerly
contained in Sec. 549.19, has been revised to require clinical
evaluation and review at least quarterly rather than monthly. This
change is being made pursuant to guidelines on managing early HIV
infection issued by the Agency for Health Care Policy and Research,
Public Health Service. Paragraph (k) restates the provisions contained
in former Sec. 549.19.
The provisions on autologous blood banking contained in former
Sec. 549.20 have been removed. Under community standards of care, these
provisions are considered to be discretionary. Because the typical
procedures for blood banking necessitate a disproportionate allocation
of Bureau resources (namely, staff escorts to community hospitals and
constraints of time schedules), the Bureau has determined that it is
impractical to offer this procedure to inmates.
The Bureau is publishing these revisions as an interim rule for two
reasons. First, the Bureau has determined that it is important to
effect these changes as quickly as possible in order to allow for the
judicious management of those contagious diseases which can pose
serious problems in the confined environment of a prison. Second, a
significant portion of the regulations are restatements of provisions
which had previously gone through proposed rulemaking. Members of the
public may submit comments concerning this rule by writing to the
previously cited address. These comments will be considered before the
rule is finalized.
The Bureau of Prisons has determined that this rule is not a
significant regulatory action for the purpose of E.O. 12866. After
review of the law and regulations, the Director, Bureau of Prisons has
certified that this rule, for the purpose of the Regulatory Flexibility
Act (Pub. L. 96-354), does not have a significant impact on a
substantial number of small entities.
List of Subjects in 28 CFR Part 549
Prisoners.
Kathleen M. Hawk,
Director, Bureau of Prisons.
Accordingly, pursuant to the rulemaking authority vested in the
Attorney General in 5 U.S.C. 552(a) and delegated to the Director,
Bureau of Prisons in 28 CFR 0.96(p), part 549 in subchapter C of 28
CFR, chapter V is amended as set forth below.
SUBCHAPTER C--INSTITUTIONAL MANAGEMENT
PART 549--MEDICAL SERVICES
1. The authority citation for 28 CFR part 549 continues to read as
follows:
Authority: 5 U.S.C. 301; 18 U.S.C. 3621, 3622, 3624, 4001, 4005,
4042, 4045, 4081, 4082, (Repealed in part as to offenses committed
on or after November 1, 1987), 4241-4247, 5006-5024 (Repealed
October 12, 1984, as to offenses committed after that date), 5039:
28 U.S.C. 509, 510; 28 CFR 0.95-0.99.
2. Subpart A, consisting of Secs. 549.10 through 549.20, is revised
to consist of Secs. 549.10 through 549.18 as follows:
Subpart A--Infectious Diseases
Sec.
549.10 Purpose and scope.
549.11 Program responsibility.
549.12 Reporting.
549.13 Medical testing.
549.14 Training.
549.15 Medical isolation and quarantining.
549.16 Duty and housing restrictions.
549.17 Confidentiality of information.
549.18 Human immunodeficiency virus (HIV) and hepatitis B virus
(HBV).
Subpart A--Infectious Diseases
Sec. 549.10 Purpose and scope.
This policy is designed to provide instruction and guidance in the
management of infectious diseases in the confined environment of a
correctional setting.
Sec. 549.11 Program responsibility.
(a) The Health Services Administrator (HSA) and Clinical Director
(CD) of each institution shall be responsible for the development and
implementation of this program.
(b) Each HSA shall designate a member of the clinical health care
staff, for example, a physician, dentist, physician assistant, nurse
practitioner, or nurse, as the Coordinator of Infectious Diseases
(CID).
Sec. 549.12 Reporting.
The HSA shall ensure that each institution's respective state
health department is informed of all cases of reportable infectious
diseases. See Sec. 549.17 for reporting requirements of chronic
infectious diseases and for Freedom of Information Act requests.
Sec. 549.13 Medical testing.
(a) Bloodborne pathogens. Following an incident in which a staff
member or an inmate may have been exposed to bloodborne pathogens,
written, informed consent shall be obtained prior to acquiring or
processing the source individual's blood or other biological specimen
for the purpose of determining an actual exposure to a bloodborne
pathogen. In the context of exposure incidents, no inmate shall be
tested forcibly or involuntarily, unless such testing is ordered by a
court with proper jurisdiction. Inmates may be subjected to
disciplinary action for assaultive behavior related to an exposure
incident.
(b) HIV testing. HIV testing programs are mandatory and include a
yearly random sample, yearly new commitment sample, new commitment re-
test sample, pre-release testing, and clinically indicated testing.
Inmates must participate in all mandatory testing programs. Staff shall
initiate an incident report for failure to follow an order for any
inmate refusing one of the mandatory HIV testing programs.
(c) Diagnostics. (1) An inmate who refuses clinically indicated
diagnostic
[[Page 52280]]
procedures and evaluations for infectious and communicable diseases
shall be subject to an incident report for failure to follow an order;
involuntary testing subsequently may be performed in accordance with
paragraph (c)(3) of this section.
(2) Any inmate who refuses clinically indicated diagnostic
procedures and evaluations for infectious and communicable diseases
shall be subject to isolation or quarantine from the general population
until such time as he/she is assessed to be non-communicable or the
attending physician determines the inmate poses no health threat if
returned to the general population.
(3) If isolation is not practicable, an inmate who refuses to
comply with or adhere to the diagnostic process or evaluation shall be
involuntarily evaluated or tested.
Sec. 549.14 Training.
The HSA shall ensure that a qualified health care professional
provides training, incorporating a question-and-answer session, about
infectious diseases to all newly committed inmates, during Admission
and Orientation (A&O). Additional training shall be provided at least
yearly.
Sec. 549.15 Medical isolation and quarantining.
(a) The CD, in consultation with the HSA, shall ensure that inmates
with infectious diseases which are transmitted through casual contact
(e.g., tuberculosis, chicken pox, measles) are isolated from the
general inmate population until such time as they are assessed or
evaluated by a health care provider.
(b) Inmates shall remain in medical isolation unless their
activities, housing, and/or duty assignments can be limited or
environmental/engineering controls or personal protective equipment is
available to eliminate the risk of transmitting the disease.
Sec. 549.16 Duty and housing restrictions.
(a) The CD shall assess any inmate with an infectious disease for
appropriateness for duties and housing. Inmates demonstrating
infectious diseases, which are transmitted through casual contact,
shall be prohibited from employment in any area, until fully evaluated
by a health care provider.
(b) Inmates may be limited in duty and housing assignments only if
their disease could be transmitted despite the use of environmental/
engineering controls or personal protective equipment, or when
precautionary measures cannot be implemented or are not available to
prevent the transmission of the specific disease. The Warden, in
consultation with the CD, may exclude inmates, on a case-by-case basis,
from work assignments based upon the classification of the institution
and the safety and good order of the institution.
(c) With the exception of the Bureau of Prisons rule set forth in
subpart E of 28 CFR part 541, there shall be no special housing
established for HIV-positive inmates.
Sec. 549.17 Confidentiality of information.
(a) Medical information relevant to chronic infectious diseases
shall be limited to members of the institutional medical staff,
institutional psychologist, and the Warden and case manager, as needed,
to address issues regarding pre- and post-release management. Prior to
an inmate's release, medical information may be shared with the United
States Probation Officer in the respective area of intended release for
the inmate and, if applicable, with the Community Corrections Manager
and the Director of the Community Correctional Center (CCC) for
purposes of post-release management and access to care. Any other
release of information shall be in accordance with the Privacy Act of
1974.
(b) All parties, with whom confidential medical information
regarding another individual is communicated, shall be advised not to
share this information, by any means, with any other person. Medical
information may be communicated among medical staff directly concerned
with a patient's case in the course of their professional duties.
Sec. 549.18 Human immunodeficiency virus (HIV) and hepatitis B virus
(HBV).
(a) During routine intake screening, all new commitments shall be
interviewed to identify those who may be HIV- or HBV-infected. Medical
personnel may request any inmates identified in this manner to submit
to an HIV or HBV test. Failure to comply shall result in an incident
report for failure to follow an order.
(b) A seropositive test result alone may not constitute grounds for
disciplinary action. Disciplinary action may be considered when coupled
with a secondary action that could lead to transmission of the virus,
e.g. sharing razor blades.
(c) A sample of all newly incarcerated inmates committed to the
Bureau of Prisons ordinarily shall be tested annually.
(d) Additionally, a random sample for HIV of all inmates in the
Bureau of Prisons shall be conducted once yearly. Inmates tested in
this random sample are not scheduled for follow-up routine retesting.
(e) After consultation with a Bureau of Prisons' health care
provider, an inmate may request an HIV/HBV antibody test. Ordinarily,
an inmate will not be allowed to test, as a volunteer, more frequently
than once yearly.
(f) A physician may order an HIV/HBV antibody test if an inmate has
chronic illnesses or symptoms suggestive of an HIV or HBV infection.
Inmates who are pregnant, inmates receiving live vaccines or inmates
being admitted to community hospitals, if required by the hospital,
shall be tested. Inmates demonstrating sexual behavior which is
promiscuous, assaultive, or predatory shall also be tested.
(g) (1) An inmate being considered for full-term release, parole,
good conduct time release, furlough, or placement in a community-based
program such as a Community Corrections Center (CCC) shall be tested
for the HIV antibody. An inmate who has been tested within one year of
this consideration ordinarily will not be required to submit to a
repeat test prior to the lapse of a one-year period. An inmate who
refuses to be tested shall be subject to an incident report for
refusing an order and will ordinarily be denied participation in a
community activity.
(2) A seropositive test result is not sole grounds for denying
participation in a community activity. Test results ordinarily must be
available prior to releasing an inmate for a furlough or placement in a
community-based program. When an inmate requests an emergency furlough,
and current (within one year) HIV and HBV antibody test results are not
available, the Warden may consider authorizing an escorted trip for the
inmate, at government expense.
(h) (1) No later than thirty days prior to release on parole or
placement in a community-based program, the Warden shall send a letter
to the Chief United States Probation Officer (USPO) in the district
where the inmate is being released, advising the USPO of the inmate's
positive HIV status. A copy of this letter shall also be forwarded to
the Community Corrections Manager. The Community Corrections Manager,
in turn, shall notify the Director of the CCC (if applicable). In all
instances of notification, precautions shall be taken to ensure that
only authorized persons with a legitimate need to know are allowed
access to the information.
(2) Prior to an HIV-positive inmate's participation in a community
activity
[[Page 52281]]
(including furloughs), notification of the inmate's infectious status
shall be made:
(i) By the Warden to the USPO in the district to be visited, and
(ii) By the Health Service Administrator to the state health
department in the state to be visited, when that state requires such
notification.
Notification is not necessary for an escorted trip.
(3) Prior to release on parole, completion of sentence, placement
in a community-based program, or participation in an unescorted
community activity, an HIV-positive inmate shall be strongly encouraged
to notify his/her spouse (legal or common-law) or any identified
significant others with whom it could be assumed the inmate might have
contact resulting in possible transmission of the virus.
(4) When an inmate is confirmed positive for HIV or HBV, the HSA
shall be responsible for notifying the state health departments in the
state in which the institution is located and the state in which the
inmate is expected to be released, when either state requires such
notification. The HSA shall ensure medical staff perform the
notification at the time of confirmed positive HIV or HBV antibody
tests.
(5) The HSA shall notify the Immigration and Naturalization Service
(INS) of any inmate testing positive who is to be released to an INS
detainer.
(i) Inmates receiving the HIV or HBV antibody test shall receive
pre- and post-test counseling, regardless of the test results.
(j) Health service staff shall clinically evaluate and review each
HIV-positive inmate at least once quarterly.
(k) Pharmaceuticals approved by the Food and Drug Administration
for use in the treatment of AIDS, HIV-infected, and HBV-infected
inmates shall be offered, when indicated, at the institution.
[FR Doc. 95-24798 Filed 10-4-95; 8:45 am]
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