Infectious Diseases

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]

BILLING CODE 4410-05-P