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Rules of the Illinois Department of
Public Health
(Cite rules as follows: 2 Ill. Adm. Code 1125)
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HIV/AIDS CONFIDENTIALITY AND TESTING
CODE
(77 ILL. ADM. CODE 697)
AUTHORITY: Implementing and authorized by the AIDS Confidentiality
Act [410 ILCS 305]; the AIDS Registry Act [410 ILCS 310]; the
Communicable Disease Prevention Act [410 ILCS 315]; and Sections 55,
55.11, 55.41 and 55.45 of the Civil Administrative Code of Illinois [20
ILCS 2310/55, 55.11, 55.41 and 55.45].
SOURCE: Emergency rules adopted at 12 Ill. Reg. 1601, effective
January 1, 1988, for a maximum of 150 days; adopted at 12 Ill. Reg.
9952, effective May 27, 1988; amended at 13 Ill. Reg. 11544, effective
July 1, 1989; amended at 15 Ill. Reg. 11646, effective August 15, 1991;
emergency amendment at 17 Ill. Reg. 1204, effective January 7, 1993, for
a maximum of 150 days; emergency expired on June 7, 1993; amended at 17
Ill. Reg. 15899, effective September 20, 1993; amended at 19 Ill. Reg.
1117, effective January 20, 1995; amended at 22 Ill. Reg. 21994,
effective December 9, 1998.
SUBPART A: GENERAL PROVISIONS
SECTION 697.10 APPLICABILITY
- This Part is in response to various statutes
concerning acquired immunodeficiency syndrome (AIDS). The provisions
of this rulemaking are organized into six components which consist of
five Subparts and one appendix. Subpart A includes general provisions
which apply to all Sections of the Part such as definitions and
administrative hearing rules.
- Subpart B includes provisions concerning testing
for the presence of antibodies to the human immunodeficiency virus
(HIV) or any other causative agent of acquired immunodeficiency
syndrome (AIDS). These provisions set forth the approved HIV tests and
testing procedures, the information that must be given by a physician
prior to ordering a HIV test, the written informed consent a physician
must obtain prior to performing a HIV test, the requirements for HIV
testing for insurance purposes, testing requirements for blood and
human tissue donations, the disclosure or confidentiality rules, and
the rules for enforcement of the AIDS Confidentiality Act.
- Subpart C includes the provisions for the
implementation of the HIV/AIDS Registry System. These provisions
include information reported and the entities which report. In
addition, provisions concerning the disclosure of registry information
are included.
- Subpart D includes provisions for the
establishment and operation of alternative test sites known as "HIV
Counseling and Testing Centers." These provisions specify how the
centers are to be used and include a brief outline of the services to
be provided.
- Subpart E includes miscellaneous provisions
which concern children. These provisions set forth the requirements
for notification of school principals of children with AIDS and HIV
infection, the guidelines for management of chronic infectious
diseases in school children, and requirements for testing, treatment
or counseling of minors.
- The appendix includes a written informed consent
form.
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.20 DEFINITIONS
The following are definitions of terms used in this Part:
"Act"
or "AIDS Confidentiality Act" means the AIDS Confidentiality Act [410
ILCS 305].
"AIDS" means acquired
immunodeficiency syndrome, as defined by the Centers for Disease Control
or the National Institutes of Health. (Section 3(a) of the AIDS Registry
Act) Similar definitions appear in the Act. Current definition can be
found in 1993 Revised Classification System for HIV Infection and
Expanded Surveillance Case Definition for AIDS Among Adolescents and
Adults, Centers for Disease Control and Prevention (CDC). Morbidity and
Mortality Weekly Report (MMWR), December 18, 1992; vol. 41, no. RR-17;
and in 1994 Revised Classification System for HIV Infection for Children
Less Than 13 Years of Age. Morbidity and Mortality Weekly Report (MMWR),
vol. 43 RR-12.
"AIDS Registry Act"
means the AIDS Registry Act [410 ILCS 310].
"Blood Bank" means any
facility or location at which blood or plasma are procured, furnished,
donated, processed, stored or distributed.
"Department" means the
Illinois Department of Public Health. (Section 3(a) of the AIDS
Confidentiality Act)
"Designated Agency"
means a health care organization under a service agreement with the
Department to function in the capacity of a Local Health Authority for
the purposes of this Part, in a jurisdiction not covered by a Local
Health Authority.
"Health Care Provider"
means any physician, nurse, paramedic, psychologist or other person
providing medical, nursing, psychological, or other health care services
of any kind. (Section 3(f) of the AIDS Confidentiality Act)
"Health Facility" means
a hospital, nursing home, blood bank, blood center, sperm bank, or other
health care institution, including any "Health Facility" as that term is
defined in the Illinois Health Facilities Authority Act. (Section 3(e)
of the AIDS Confidentiality Act)
"HIV" means the human immunodeficiency virus. (Section 3(c) of the AIDS
Confidentiality Act)
"Mortality" or "HIV
infection" means infected with HIV, as evidenced by a confirmed
laboratory test for antibodies to HIV as specified in Section 697.100,
viral culture or positive antigen test or a clinical diagnosis of AIDS.
"Laboratory" means any
facility or location at which tests are performed to determine the
presence of antibodies to HIV, other than blood banks.
"Legally Authorized
Representative" means an individual who is authorized to consent to HIV
testing and/or disclosure of HIV test results for an individual who is:
Under the age of
twelve (12),
Deceased,
Declared incompetent by a court of law, or
Otherwise not competent to consent (for reasons other than age, such as
the apparent inability to understand or communicate with the health care
provider) as determined by the health care provider seeking such
consent.
The following
individuals shall be authorized to consent, in the stated order of
priority:
For a living or
deceased child under the age of 18:
Parent,
Legal guardian or other court-appointed personal representative,
Adult next-of-kin.
For a living or
deceased adult age 18 or over:
Agent authorized by
durable power of attorney for health care,
Legal guardian or other court-appointed personal representative,
Spouse,
Adult children,
Parent,
Adult next-of-kin.
"Local Health Authority" means the full-time official health Department
or Board of Health, having jurisdiction over a particular area.
(Illinois Sexually Transmissible Disease Control Act. [410 ILCS 325])
"Person" includes any
natural person, partnership, association, joint venture, trust,
governmental entity, public or private corporation, health facility or
other legal entity. (Section 3(h) of the AIDS Confidentiality Act)
"Physician" means a
physician licensed to practice medicine under the Medical Practice Act
of 1987 [225 ILCS 60]. "Test" or "HIV Test" means a test to determine
the presence of the antibody or antigen to HIV, or of HIV infection.
(Section 3(g) of the AIDS Confidentiality Act)
"Written Informed
Consent" means an agreement in writing executed by the subject of a test
or the subject's legally authorized representative without undue
inducement such as any element of force, fraud, deceit, duress or other
form of constraint or coercion (See Appendix A, Illustration A), which
entails at least the following:
A fair explanation of
the test, including its purpose, potential uses, limitations and the
meaning of its results; and
A fair explanation of
the procedures to be followed, including the voluntary nature of the
test, the right to withdraw consent to the testing process at any time
prior to the completion of the laboratory tests, the right to anonymity
to the extent provided by law with respect to participation in the test
and disclosure of test results, and the right to confidential treatment
of information identifying the subject of the test and the results of
the test, to the extent provided by law. (Section 3(d) of the AIDS
Confidentiality Act)
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.30 INCORPORATED MATERIALS
The following materials are incorporated or referenced in this Part:
- Illinois Statutes
- AIDS Confidentiality Act [410 ILCS 305],
- AIDS Registry Act [410 ILCS 310],
- The Communicable Disease Prevention [410 ILCS
315],
- The Unified Code of Corrections [730 ILCS 5],
- The Medical Patient Rights Act [410 ILCS 50],
- The Civil Administrative Code of Illinois [20
ILCS 2310/55 to 55.45].
- Illinois Rules
- Control of Communicable Disease Code (77 Ill.
Adm. Code 690) (see in particular Section 697.140(a)(4) of this
Part),
- Control of Sexually Transmissible Diseases
Code (77 Ill. Adm. Code 693) (see in particular Sections
697.140(a)(4) and 697.210(a) of this Part),
- Illinois Clinical Laboratories Code (77 Ill.
Adm. Code 450) (see in particular Section 697.180(c) and (e)),
- Blood Labeling Code (77 Ill. Adm. Code 460)
(see in particular Section 697.180(c) and (e) of this Part),
- Sperm Bank and Tissue Bank Code (77 Ill. Adm.
Code 470) (see in particular Section 697.180(c) and (e)),
- Rules of Practice and Procedure in
Administrative Hearings (77 Ill. Adm. Code 100) (see in particular
Section 697.40 of this Part),
- Illinois Blood Bank Code (77 Ill. Adm. Code
490).
- Federal Rules 42 CFR 2a.4(a)-(j), 2a.6(a)-(b),
and 2a.7(a)-(b).
- Other Codes, Guidelines and Standards
- 1993 Revised Classification System for HIV
Infection and Expanded Surveillance Case Definition for AIDS Among
Adolescents and Adults, Centers for Disease Control and Prevention (CDC).
Morbidity and Mortality Weekly Report (MMWR), December 18, 1992;
vol. 41, no. RR-17.
- 1994 Revised Classification System for HIV
Infection for Children Less Than 13 Years of Age. Centers for
Disease Control and Prevention (CDC). Morbidity and Mortality Weekly
Report (MMWR), vol. 43 (RR-12).
- The "Adult HIV/AIDS Confidential Case Report",
as modified by the Department, a form prepared by the Centers for
Disease Control and Prevention, Public Health Service, U.S.
Department of Health and Human Services, Atlanta, Georgia 30333,
Office of Management and Budget No. 0920-0009. (1993) (See Section
697.210.)
- Guidelines for the Management of Chronic
Infectious Diseases in School Children. (See Section 697.410.)
- 1993 Revised Classification Scheme for HIV
Infection and Expanded Surveillance Case Definiton for AIDS Among
Adolescents and Adults, Centers for Disease Control and Prevention,
Morbidity and Mortality Weekly Report (MMWR). Vol. 41, No. RR-17,
December 18, 1992, Public Health Service, U.S. Department of Health
and Human Services, Atlanta, Georgia 30333.
- All citations to federal regulations in this
Part concern the specified regulations in the 1994 Code of Federal
Regulations, unless another date is specified.
- All incorporations by reference of federal
regulations or standards and the standards of nationally recognized
organizations refer to the regulations and standards on the date
specified and do not include any additions or deletions subsequent to
the date specified.
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.40 ADMINISTRATIVE HEARINGS
Any administrative hearings conducted by the Department concerning
the provisions of this Part shall be governed by the Department's Rules
of Practice and Procedure in Administrative Hearings (See 77 Ill. Adm.
Code 100).
SUBPART B: HIV TESTING
SECTION 697.100 APPROVED HIV TESTS AND TESTING PROCEDURES
- Any person, laboratory, blood bank, hospital or
other entity which conducts laboratory tests to detect the evidence of
infection with HIV shall use tests approved by the United States Food
and Drug Administration or the Department. The following test are
currently approved for such purpose by the Department:
- Enzyme-linked Immunosorbent Assay (ELISA)
(screening);
- Western blot assay (confirmatory);
- Indirect fluorescent antibody test (IFA)
(confirmatory);
- Recombinant antigen HIV-1 latex agglutination
test (screening and confirmatory);
- Radioimmune precipitation assay (RIPA)
(confirmatory);
- Polymerase chain reaction (PCR) test
(confirmatory).
- Testing for the presence of antibodies to the
HIV virus shall consist of the following:
- Every sample shall be tested with an approved
screening test. If found to be reactive (according to the package
insert - product circular), then a second screening test, in
duplicate, must be conducted. If the second screening test is also
found to be reactive, then a confirmatory test must be conducted.
- Every sample found to be repeatedly reactive
using an approved screening test shall be tested using a
confirmatory test. If the sample is found to be positive according
to the package insert (product circular) using the Western blot
assay, or reactive according to the manufacturer's recommendations
using the IFA test, then the sample shall be considered to indicate
the presence of antibodies to the HIV or to be positive.
- In the event the confirmatory test is found to
be indeterminate, then the specimen should be tested with another
supplemental test as listed above. If the sample is found to be
positive according to the package insert (product circular) or
manufacturer's recommendations for that test, then the sample shall
be considered to indicate the presence of antibodies to HIV or to be
positive.
- All phases of testing required by this Section
shall be completed before HIV test results are released to the
physician or other individuals authorized to receive the results.
(Source: Amended at 15 Ill. Reg. 11646, effective
August 15, 1991)
SECTION 697.110 HIV PRE-TEST INFORMATION
- No physician may order an HIV test without
making available to the person tested pre-test information, except as
provided in subsection (b) below. The responsibility of providing
pre-test information may not be delegated by the physician. However,
the task of providing pre-test information to the patient may be
delegated to another health care provider who is knowledgeable about
HIV infection including possible medical and psychosocial aspects of
such infection. The required pre-test information consists of the
following information:
- About the meaning of the test results (Such as
the purpose, potential uses, limitations of the test and test
results, and the statutory rights to anonymous testing and to
confidentiality),
- The availability of additional or confirmatory
testing, if appropriate (See Section 687.100(b)), and
- The availability of referrals for further
information or counseling. (Section 5 of the AIDS Confidentiality
Act).
- Pre-test information when ordering an HIV test
is not required in the following situations:
- When the Health Care provider or health
facility procures processes, distributes or uses a human body part
donated for purposes specified under the Uniform Anatomical Gift Act
or the Organ Alternative Treatments Request Act and the test is performed to
assure the medical acceptability of the human body part. (Section 7
of the AIDS Confidentially Act.)
- When the testing is for the purpose of
research and performed in such a way that the identity of the test
subject is not known and may not be retrieved by the researcher, and
in such a way that the test subject is not informed of the results
of the testing. (Section 8 of the AIDS Confidentiality Act.)
- When an insurance company, fraternal benefit
society, health services corporation, health maintenance
organization, or any other insurer subject to regulation under the
Illinois Insurance Code, as amended, requires any insured patient or
applicant for new or continued insurance or coverage to be tested
for infection with HIV virus or any other identified causative agent
of AIDS. (Section 3 of AN ACT concerning certain rights of medical
patients, Ill. Rev. Stat. 1987, ch. 111 1/2, par. 5403 ). (See
Section 697.170.)
- When in the judgment of the physician, such
testing is medically indicated to provide appropriate diagnosis and
treatment to the subject of the test, provided that the subject of
the test has otherwise provided his or her consent to such physician
for medical treatment. (Section 8 of the AIDS Confidentiality Act).
(Source: Amended at 13 Ill. Reg. 11544, effective
July 1, 1989)
SECTION 697.120 WRITTEN INFORMED CONSENT
- No person may order an HIV test without first
receiving the written, informed consent of the subject of the test or
the subject's legally authorized representative, except as provided in
subsection (b). (Section 4 of the AIDS Confidentiality Act)
- This written informed consent and test results
must be obtained by the physician ordering the test or by another
physician involved in the patient's care.
- The responsibility of obtaining written
informed consent may not be delegated by the physician. However, the
task of obtaining written informed consent from the patient may be
delegated to another health care provider who is knowledgeable about
HIV infection, including possible medical and psychosocial aspects
of such infection.
- Written informed consent to perform an HIV test
is not required in the following situations:
- When the health care provider or health
facility procures, processes, distributes or uses a human body part
donated for purposes specified under the Uniform Anatomical Gift Act
or the Organ Alternative Treatments Request Act and the test is performed to
assure the medical acceptability of the human body part. (Section 7
of the AIDS Confidentiality Act)
- When the health care provider or health
facility procures, processes, distributes or uses semen provided
prior to September 21, 1987, for the purpose of artificial
insemination and the test is performed to assure the medical
acceptability of the semen. (Section 7 of the AIDS Confidentiality
Act)
- When the testing is for the purpose of
research and performed in such a way that the identity of the test
subject is not known and may not be retrieved by the researcher, and
in such a way that the test subject is not informed of the results
of the testing. (Section 8 of the AIDS Confidentiality Act)
- When an HIV test is performed upon a person
who is specifically required by state or federal law to be tested,
such as blood, plasma, semen and human tissue donors, immigrants to
the United States, and persons required to be tested pursuant to
Section 5-5-3 of the Unified Code of Corrections). (Section 11 of
the AIDS Confidentiality Act)
- When an insurance company, fraternal benefit
society, health services corporation, health maintenance
organization, or any other insurer subject to regulation under the
Illinois Insurance Code, as amended requires any insured patient or
applicant for new or continued insurance or coverage to be tested
for infection with HIV or any other identified causative agent of
AIDS. (Section 3 of the Medical Patient Rights Act [410 ILCS 50/3])
(See Section 697.160.)
- When a health care provider or employee of a
health facility, or a firefighter or an Emergency Medical
Technician-Ambulance (EMT-A), Emergency Medical
Technician-Intermediate (EMT-I) or Emergency Medical
Technician-Paramedic (EMT-P) is involved
in an
accidental direct skin or mucous membrane contact with the blood or
bodily fluids of an individual which is of a nature that may transmit
HIV, as determined by a physician in his medical judgment. Should such
test prove to be positive, the patient shall be provided appropriate
counseling consistent with this Act. (Section 7 of the AIDS
Confidentially Act).
7.
When in the judgment of the physician, such testing is medically
indicated to provide appropriate diagnosis and treatment to the subject
of the test, provided that the subject of the test has otherwise
provided his or her consent to such physician for medical treatment.
(Section 8 of the AIDS Confidentiality Act).
8.
For a health care provider or health facility to perform a test
when a law enforcement officer is involved in the line of duty in a
direct skin or mucous membrane contact with the blood or bodily fluids
of an individual which is of a nature that may transmit HIV, as
determined by a physician in his medical judgment. Should such test
prove to be positive, the patient shall be provided appropriate
counseling consistent with this Act. For purposes of Section 7 (c) of
the Act, "Law Enforcement Officer" means any person employed by the
State, a county or a municipality as a policeman, peace officer,
auxiliary-policeman, correctional officer or in some like position
involving the enforcement of the law and protection of the public
interest at the risk of that persons life. (Section 7 of the AIDS
Confidentiality Act)
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.130 ANONYMOUS TESTING
Any person upon whom an HIV test is performed shall have the right to
request anonymity and to provide written informed consent by using a
coded system that does not link individual identity with the request or
the result except when written informed consent is not required by law
as specified in Section 697.120. (Section 6 of the AIDS Confidentiality
Act.) Any anonymous testing system adopted by the health care provider
ordering the test must ensure that the correct test results are
transmitted by the persons conducting the laboratory tests to the proper
physician, and that the correct test results are given to the correct
patient. When a test subject does not have the right to request
anonymity, the test subject may request that the blood sample be labeled
in such a manner as to prevent persons from learning the identity of the
test subject unless such persons are authorized to receive such
information pursuant to Section 697.140 of this Part.
- If anonymous testing is requested, the physician
shall assign to such person a unique number or notation, which shall
be used by the person to sign the written informed consent in lieu of
the person's name. The blood sample for testing shall be labeled with
the physician's name and the unique number or notation assigned to the
patient for the purpose of receiving the test results. Unless
otherwise authorized by the patient, any record of the test result
shall be maintained in a manner identifying the record only by its
unique number or notation.
- Anonymous testing shall not be permitted under
the following circumstances:
- When identification of the test subject is
permitted or required in order to comply with the provisions of
Section 697.140(a)(3) or (6) of this Part, or
- If the test is performed in order to determine
eligibility as a donor or acceptability of a Alternative Treatments of blood,
plasma, semen, oocytes or other human tissue.
(Source: Amended at 15 Ill. Reg. 11646, effective
August 15, 1991)
SECTION 697.140 NONDISCLOSURE OF THE IDENTITY OF A PERSON TESTED OR
TEST RESULTS
- No person may disclose or be compelled to
disclose the identity of any person upon whom a test is performed, or
the results of such a test in a manner which permits identification of
the subject of the test, except to the following persons (Section 9 of
the AIDS Confidentiality Act):
- The subject of the test or the subject's
legally authorized representative (Section 9(a) of the AIDS
Confidentiality Act).
- Any person designated in a legally effective
release of the test results executed by the subject of the test or
the subject's legally authorized representative. (Section 9(b) of
the AIDS Confidentiality Act) A legally effective release means a
written release of medical information specific to HIV test results
signed by the test subject. A general release is not sufficient. A
single form may be used to authorize the release of medical records
including HIV information provided such form specifically authorizes
the release of any HIV information. Any such release, under this
subsection, for HIV information must not reveal whether or not the
information exists.
- An authorized agent or employee of a health
facility or health care provider or referring, treating or
consulting physician, dentist, or podiatrist of the test subject,
if:
A.
The health facility or health care provider itself is authorized
to obtain the test results (Health Facility or Health Care Provider, for
the purposes of this subsection (a)(3)(A), include the medical records
or similar personnel who handle and process medical records for that
health facility or health care provider),
B.
The agent or employee or referring, treating or consulting
physician, dentist, or podiatrist of the test subject provides patient
care or handles or processes specimens of body fluids or tissues, and
C.
The agent or employee or referring, treating or consulting
physician of the test subject has a need to know such information.
(Section 9(c) of the AIDS Confidentiality Act) An authorized agent or
employee of a health facility or health care provider or referring,
treating or consulting physician, dentist, or podiatrist has a need to
know the identity of the patient or the test results revealing the
identity of the patient under the following circumstances:
i.
When involved in direct patient care or handling or processing
blood or bodily fluids for which this information is necessary in order
to meet the medical needs of the patient, as certified by a physician,
dentist, or podiatrist, or
ii.
When involved in an accidental direct skin or mucous membrane
contact with the blood or bodily fluids of a patient which is of a
nature likely to transmit HIV, such as needle stick or percutaneous
exposure, as certified by a physician, dentist, or podiatrist.
D.
The Department or the Local Health Authority, in accordance with
rules for reporting and controlling the spread of disease, or as
otherwise provided by State law (See 77 Ill. Adm. Code 690, 693, 250,
300, 330, 350, 370, 390, and 840.). Neither the Department nor its
authorized representatives shall disclose information and records held
by them relating to known or suspected cases of AIDS or HIV infection,
publicly or in any action of any kind in any court or before any
tribunal, board or agency. AIDS and HIV Infection shall be protected
from disclosure in accordance with the provisions of Sections 8-2101
through 8-2105 of the Code of Civil Procedure. (Section 9(d) of the AIDS
Confidentiality Act)
E.
A health facility or health care provider which procures,
processes, distributes or uses:
A.
A human body part from a deceased person with respect to medical
information regarding the person; or
B.
Semen provided prior to September 21, 1987, for the purpose of
artificial insemination (Section 9(e) of the AIDS Confidentiality Act);
6.
Health facility staff committees for the purpose of conducting
program monitoring, program evaluation or service reviews (Section 9(f)
of the AIDS Confidentiality Act);
7.
A school principal in accordance with the provisions of Section
697.400 of this Part.
8.
Any health care provider or employee of a health facility, and
any firefighter or any EMT-A, EMT-I, EMT-P involved in an accidental
direct skin or mucous membrane contact with the blood or bodily fluids
of an individual which is of a nature that may transmit HIV, as
determined by a physician in his medical judgment. (Section 9(h) of the
AIDS Confidentiality Act)
9.
Any law enforcement officer, as defined in subsection (c) of
Section 7 of the Act, involved in the line of duty in a direct skin or
mucous membrane contact with the blood or bodily fluids of an individual
which is of a nature that may transmit HIV, as determined by a physician
in his medical judgment. (Section 9(i) of the AIDS Confidentiality Act)
10.
A temporary caretaker of a child taken into temporary protective
custody by the Department of Children and Family Services pursuant to
Section 5 of the Abused and Neglected Child Reporting Act, as now or
hereafter amended. (Section 9(j) of the AIDS Confidentiality Act)
- HIV test results may be disclosed to health care
providers and researchers when done in a manner which does not reveal
the identity of the subject of the test. Any test results which cannot
be revealed without identifying the subject of the test shall only be
disclosed in accordance with the provisions of subsection (a)
specified above. The Department shall disclose test results and
demographic data without identifying information to researchers in
accordance with Section 697.220.
- The written informed consent form and HIV test
results may be maintained in a confidential manner which allows
disclosure only to persons authorized to receive the information under
the provisions of subsection (a) specified above.
- The written informed consent form and HIV test
results may be maintained in a patient's medical record provided
these materials are maintained in such a manner that does not permit
disclosure to persons who may review the patient's medical record,
but are not authorized to receive this information.
- Any procedure utilized to maintain this
information in a patient's medical record must be uniform and
consistent for all patient records, in order to prevent revealing
the existence or contents of this information. A procedure is
uniform if medical records containing written informed consent forms
and HIV test results cannot be distinguished from medical records
which do not contain such information, unless the medical record is
accessed and read. An example of such a procedure is one which
establishes a segregated or separate confidential sealed portion of
the medical record in every patient record with access restricted to
persons authorized to receive the contents.
- Liability and Sanctions
- Nothing is this Act shall be construed to
impose civil liability or criminal sanction for disclosure of a test
result in accordance with any reporting requirement of the
Department for a diagnosed case of HIV infection, AIDS or a related
condition. (Section 15 of the Aids Confidentiality Act)
- Nothing in this Act shall be construed to
impose civil or criminal sanction for performing a test without
written informed consent pursuant to the provisions of subsection
(b) or (c) of Section 7 of the AIDS Confidentiality Act.
(Section 15 of the AIDS Confidentiality Act)
3.
The intentional or reckless violation of the AIDS Confidentiality
Act or any regulation issued under that Act shall constitute a Class B
misdemeanor. (Section 12 of the AIDS Confidentiality Act)
- Sections 697.110, 697.120, 697.130 and 697.140
shall not apply to eligibility and coverage requirements established
by a health maintenance organization nor to any insurance company
fraternal benefit society, or other insurer regulated under the
Illinois Insurance Code. (Section 15.1 of the AIDS Confidentiality
Act)
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.150 MARRIAGE LICENSE TESTING REQUIREMENTS (REPEALED)
(Source: Repealed at 15 Ill. Reg. 11646, effective August 15, 1991)
SECTION 697.160 HIV TESTING FOR INSURANCE PURPOSES
- Health maintenance organizations, insurance
companies, fraternal benefit societies, health services corporations
and other insurers subject to regulation under the Illinois Insurance
Code are not required to comply with the provisions of Sections
697.110, 697.120, 697.130 and 697.140 in establishing eligibility and
coverage requirements which include mandatory HIV tests. This
exemption also extends to the physician or other health care provider
that performs such tests.
- Health maintenance organizations, insurance
companies, fraternal benefit societies, health services corporations
and other insurers subject to regulation under the Illinois Insurance
Code that require any insured patient or applicant for new or
continued insurance or coverage to be tested for infection with Human
Immunodeficiency Virus (HIV) or any other identified causative agent
or Acquired Immunodeficiency Syndrome (AIDS) shall:
- Give the patient or applicant prior written
notice of such requirement,
- Proceed with such testing only upon the
written authorization of the applicant or patient, and
- Keep the results of such testing confidential.
- Notice of an adverse underwriting or coverage
decision may be given to any appropriately interested party, but the
insurer may only disclose the test result itself to a physician
designated by the applicant or patient, and any such disclosure shall
be in a manner that assures confidentiality. (Section 2.02 of "AN ACT
concerning certain rights of medical patients").
(Source: Amended at 15 Ill. Reg. 11646, effective
August 15, 1991)
SECTION 697.170 ENFORCEMENT OF THE AIDS CONFIDENTIALITY ACT
- All health facilities and health care providers
are required to comply with the provisions of this Part. Any failure
to comply will be addressed in accordance with the following:
- Health facilities and health care providers
that are licensed, certified, permitted or given any other form of
recognition by the Department shall comply with the provisions of
Sections 697.110, 697.120, 697.130 and 697.140 of this Part, as such
provisions are applicable to the health facilities and health care
providers as a condition of such licensure, certification, permit or
any other form of recognition by the Department. The reckless,
deliberate or conscious failure to comply with such provisions shall
constitute grounds for suspension, revocation or denial in
accordance with the respective licensure, certification, permit and
other recognition laws and regulations.
- The Department shall forward to the
appropriate state, federal, or local regulatory agency, any
complaint which it receives concerning the failure by any health
facility or health care provider, which is subject to regulation by
such agency, to comply with the provisions of Sections 697.110,
697.120, 697.130 and 697.140 of this Part, as such provisions are
applicable to the health facilities and health care providers.
- The intentional or reckless violation of the
AIDS Confidentiality Act or any regulations issued thereunder shall
constitute a class B misdemeanor. (Section 12 of the AIDS
Confidentiality Act.)
- Civil remedy provisions can be found in Section
13 of the AIDS Confidentiality Act.
(Source: Amended at 15 Ill. Reg. 11646, effective
August 15, 1991)
SECTION 697.180 HIV TESTING FOR BLOOD AND HUMAN TISSUE DONATIONS
All potential donors of blood, plasma, semen, oocytes, organs, or
other tissues shall be tested for HIV infection in order to determine
whether or not the donated blood, plasma, semen, oocytes, organs, or
other human tissue may be infected with HIV.
- All potential donors shall receive the HIV
pre-test information set forth in Section 697.110(a) of this Part and
be given the opportunity to refuse HIV testing. The written informed
consent provisions of Section 697.120 of this Part are not required.
- If permission for HIV testing is not given, then
the person shall not be accepted as a donor.
- The results of HIV testing shall be disclosed in
accordance with the provisions of Section 697.140 of this Part, 77
Ill. Adm. Code 450, 77 Ill. Adm. Code 460, 77 Ill. Adm. Code 490 and
77 Ill. Adm. Code 470.
- The results of HIV testing shall be kept
confidential in accordance with the provisions of Section 697.140 of
this Part.
- The donated blood, plasma, semen, oocytes,
organs or other human tissue shall be handled in accordance with the
provisions of 77 Ill. Adm. Code 450, 77 Ill. Adm. 460, 77 Ill. Adm.
Code 490 and 77 Ill. Adm. Code 470.
(Source: Amended at 15 Ill. Reg. 11646, effective
August 15, 1991)
SUBPART C: HIV-AIDS REGISTRY SYSTEM
SECTION 697.200 HIV-AIDS REGISTRY SYSTEM
The HIV/AIDS Registry System has been created to compile more
complete and precise statistical data than is presently available in
order to evaluate AIDS treatment and prevention measures. The HIV/AIDS
Registry System is a compilation of information concerning diagnosed
cases of AIDS and HIV.
(Source: Amended at 22 Ill. Reg. 21994, effective December 9, 1998)
SECTION 697.210 REPORTING REQUIREMENTS
- Local Health Authorities which receive HIV/AIDS
reports from physicians, hospitals or laboratories shall report to the
HIV/AIDS Registry System within seven days after receiving the AIDS
report. Prior to forwarding an HIV report to the Department, a Local
Health Authority shall replace an individual's name with a unique
identifier derived by methodology specified by the Department. (See
Control of Sexually Transmissible Disease Code, 77 Ill. Adm. Code
693.30.)
- The report shall be provided upon the "HIV/AIDS
Confidential Case Report", as modified by the Department, a form
prepared by the Centers for Disease Control and Prevention, Public
Health Service, U.S. Department of Health and Human Services, Atlanta,
Georgia 30333, OMB No. 0920-0009 and supplied by the Department.
- The Department requests, but does not require,
hospitals maintained by the Federal Government or other governmental
agencies within the United States to report HIV/AIDS case information
concerning present or past residents of Illinois, using the "HIV/AIDS
Confidential Case Report", as modified by the Department.
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.220 RELEASE OF HIV-AIDS REGISTRY INFORMATION
- The Department may not release information
gathered pursuant to the AIDS Registry Act unless:
- It is in statistical form that does not
identify the reporting entity, physician or patient in any way,
including by address;
- The release or transfer is to an Illinois
Local Public Health Department or to a registry or health department
of another state, and is of information concerning a person who is
residing in that jurisdiction. The Department shall disclose
individual patient information concerning residents of another state
to the Registry in the individual's state of residence if the
recipient of reported information about HIV/AIDS is legally required
to hold reported information about HIV/AIDS in confidence and
provides protection from disclosure of patient identifying
information equivalent to the protection afforded by the Illinois
law. (Section 7(a) of the AIDS Registry Act)
- All data obtained directly from medical records
of individual patients shall be for the confidential use of the
Department and those entities authorized by the Department to view
such records in order to carry out the purposes of the Registry Act.
(Section 7(b) of the AIDS Registry Act)
- The identity of any person whose condition or
treatment has been studied, or any facts which are likely to reveal
the identity of such person, shall be confidential and shall not be
revealed in any report or any other matter prepared, released or
published. Researchers may, however, use the names of persons when
requesting additional information for research studies approved by the
Department; provided however, that when a request for additional
information is to be made, the Department shall first obtain
authorization from the patient or the patient's legally authorized
representative after ascertaining that a test subject's physical and
psychological condition is suitable for such a request in the opinion
of the test subject's physician. (Section 7(c) of the AIDS Registry
Act)
- All requests by medical or epidemiologic
researchers for confidential Registry data must be submitted in
writing to the Registry. The request must include a study protocol
which contains: objectives of the research; rationale for the
research including scientific literature justifying current
proposal; overall study methods, including copies of forms,
questionnaires, and consent forms used to contact facilities,
physicians or study subjects including methods for documenting
compliance with 42 CFR 2a.4(a)-(j), 2a.6(a)-(b), and 2a.
7(a)-(b)(1); methods for the processing of data; storage and
security measures taken to insure confidentiality of patient
identifying information; time frame of the study; a description of
the funding source of the study (e.g., federal contract); the
curriculum vitae of the principal investigator and a list of
collaborators. In addition, the research request must specify what
patient or facility identifying information is needed and how the
information will be used.
- All requests to conduct research and
modifications to approved research proposals involving the use of
data which includes patient or facility identifying information
shall be subject to a review to determine compliance with the
following conditions. The Department will enter into contracts for
research which require the release of patient or facility
identifying information when requests meet the following conditions:
A.
The request for patient or facility identifying information
contains stated goals or objectives;
B.
The request documents the feasibility of the study design in
achieving the stated goals and objectives;
C.
The request documents the need for the requested data to achieve
the stated goals and objectives;
D.
The requested data can be provided within the time frame set
forth in the request;
E.
The request documents that the researcher has qualifications
relevant to the type of research being conducted;
F.
The research will not duplicate other research already underway
using the same Registry data; and
G.
The request documents other such conditions relevant to the need
for the patient or facility identifying information and the patient's
confidentiality rights, because the Department will only release the
patient or facility identifying information which is necessary for the
research.
3.
The Department will enter into research contracts for all
approved research requests. These contracts shall specify exactly what
information is being released and how it can be used. In addition, the
researcher shall include assurances that:
A.
The researcher understands that use of data is restricted to the
specifications of the protocol;
B.
The researcher understands that any and all data which may lead
to the identity of any patient, research subject, physician, other
person, or hospital are strictly privileged and confidential and agrees
to keep all such data strictly confidential at all times;
C.
The researcher understands that all officers, agents and
employees are to keep all such data strictly confidential;
D.
The researcher agrees to communicate the requirements of this
Section to all officers, agents, and employees, to discipline all
persons who may violate the requirements of this Section, and to notify
the Department in writing within 48 hours after any violation of this
Section, including full details of the violation and corrective actions
to be taken;
E.
The researcher understands that all data provided by the
Department pursuant to this contract may only be used for the purposes
named in this contract and that any other or additional use of the data
shall result in immediate termination of this contract by the
Department; and
F.
The researcher understands that all data provided by the
Department pursuant to this contract is the sole property of the
Department and may not be copied or reproduced in any form or manner and
agrees to return all data and all copies and reproduction of the data to
the Department upon termination of the contract.
4.
Any departures from the approved protocol must be submitted in
writing and approved by the Director in accordance with subsection
(c)(2) of this Section prior to initiation. No patient or facility
identifying information may be released by a researcher to a third
party.
5.
The Department shall disclose individual patient or facility
information to the reporting facility which originally supplied that
information to the Department, upon written request of the facility.
- HIV/AIDS information may be disclosed in
accordance with the provisions of Sections 697.140 and 697.400 of this
Part.
- No liability shall attach to any hospital,
physician or other facility submitting information pursuant to this
Act based upon a claim that such hospital, physician or facility
reported information which may be confidential. (Section 7(d) of the
AIDS Registry Act)
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SUBPART D: HIV COUNSELING AND TESTING CENTERS
SECTION 697.300 HIV COUNSELING AND TESTING CENTERS
- The Department shall establish alternative blood
and HIV test services, known as "HIV Counseling and Testing Centers".
Such facilities shall be operated by the Department or Designated
Agencies. These facilities shall provide services in accordance with
the provisions of this Part and the applicable provisions of the
Sexually Transmissible Diseases Code (77 Ill. Adm. Code 693,
specifically Sections 693.40, 693.70, 693.80, 693.90, 693.100,
693.120, 693.130 and 693.140.)
- These facilities shall not be operated by
blood banks, plasma centers or hospitals. (Section 55.41 of the
Civil Administrative Code of Illinois)
- Physicians and other health care providers may
refer HIV-infected persons to these facilities for counseling.
- Any person twelve years of age or older may
consent to testing and counseling at an HIV Counseling and Testing
Center.
- No person may be subjected to an HIV antibody
test at HIV Counseling and Testing Centers, unless written informed
consent is first obtained from the test subject or the test subject's
legally authorized representative. (See Appendix A, Illustration A for
a Sample Written Informed Consent Form.)
- All persons seeking counseling and testing at a
HIV Counseling and Testing Center shall remain anonymous and shall
provide written informed consent using a coded system. All patient
records shall be maintained using this code system.
- The HIV Counseling and Testing Centers shall
provide counseling to the test subject prior to performing the test.
Such counseling shall include, but not necessarily be limited to:
- information about the natural history of HIV
infection and HIV transmission;
- information about the meaning of the test and
test results; such as the purpose, potential uses, limitations of
the test and test results and the statutory rights to anonymous
testing and to confidentiality; and about the availability of
additional or confirmatory testing;
- information about the availability of
referrals for further information, or counseling; and
- methods for prevention of transmission of HIV.
- Contact interview and investigation services
shall be provided only by counselors who have completed a course of
training which included instruction in the following:
- The etiology and transmission of HIV,
including associated risk behaviors and activities and patient
profiles of persons as significant risk of HIV infection;
- The natural history and progression of HIV
infection;
- Methods for preventing transmission of HIV
infection;
- Principles and techniques of counseling,
including demonstration of interviewing and counseling skills needed
for epidemiologic management of HIV infected persons, critiqued
role-playing, psychologic assessment and crisis intervention;
- Principles and techniques of contact
investigation and referral; and
- Principles of communicable diseases.
- It shall be the duty of every person providing
results of an HIV antibody test to provide the subject of the test
with an explanation of the test results, methods for prevention of HIV
transmission, and referrals for medical and psychological follow-up
appropriate to the needs of the test subject. These referrals shall
include appropriate referrals to physicians who will provide services
to seropositive individuals, tuberculosis and sexually transmissable
disease services facilities for psychological counseling and crisis
intervention and substance abuse treatment facilities as available.
- All persons with a positive HIV antibody test
shall be offered the assistance of health professionals in locating
and referring sex and needle sharing contacts for counseling and
testing, with the consent of the infected person. All persons refusing
such assistance shall be strongly encouraged to notify their previous
sex and needle sharing contacts of their possible exposure to HIV, and
to refer such contacts for counseling and possible testing.
- HIV infected persons shall be asked to
identify their sex and needle-sharing contacts for the preceding
twelve month period. The counselor shall discuss the specific nature
of each contact with the client to determine the likelihood of HIV
transmission based on the type of sexual or needle-sharing practice
involved and the counselor's knowledge of risk factors.
- Those contacts determined to be at significant
risk of infection, in the professional judgment of the counselor
based on the type of sexual or needle sharing practice involved and
the counselor's knowledge of risk factors, shall be investigated.
Investigation shall be conducted for contacts for whom sufficient
information to identify the person is available, such as first and
last name, street address, or telephone number.
- The counselor may prioritize the order in
which contacts are to be investigated. The counselor shall provide
first priority to those contacts who (based again on the counselor's
professional judgement), except for contact notification, may not
have reason to suspect they may be infected because the counselor
has no information that the contacts:
A.
are aware of having engaged in behavior likely to result in
exposure; and/or
B.
are knowledgeable about the type of behavior carrying such risks.
4.
Persons choosing to self-refer their contacts shall receive
intensive individualized instruction and counseling in methods to
provide this notification and referral.
5.
Contacts to persons with HIV infection, identified through the
contact interview and investigative process, shall be counseled,
confidentially and in person, regarding the possibility of infection,
methods to prevent the spread of the infection, and services available
from public health agencies. Such persons shall also be offered testing
to determine infection.
6.
If such person is legally unable to agree to counseling due to
age or legal incompetence, consent and participation in counseling shall
be requested of the individual's parent or legal guardian. If such
person is legally able to agree to but appears to be incapable of
understanding and competently acting on such counseling, in the
professional judgment of the counselor, participation in counseling
shall be requested of a parent or other person chosen by the client.
- It shall be the duty of every person conducting
an HIV test in a HIV Counseling and Testing Center to provide results
of the test only to the individual upon whom the test was performed.
Such results are to be provided only in an individual face-to-face
interview. The test subject may elect to have other persons present
during the interview. It shall be the duty of the person providing the
counseling to determine that the presence of a second party during the
interview is not the result of undue inducement such as any element of
force, fraud, deceit or other constraint or coercion.
- It shall be the duty of every person with access
to an individual's HIV antibody test results to maintain strict
confidentiality of those results and the test subject's identity as
required by law as specified in Section 697.140.
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SUBPART E: MISCELLANEOUS PROVISIONS
SECTION 697.400 NOTIFICATION OF SCHOOL PRINCIPALS
- Whenever a child of school age is reported to
the Department or to a local health department as having been
diagnosed as having AIDS or as having been shown to have been exposed
to Human Immune Deficiency Virus (HIV) (or any other identified
causative agent of AIDS) by testing positive on a Western Blot Assay
or more reliable tests as specified in Section 697.100, such
department shall give prompt (within three working days) and
confidential notice of the identity of the child to the principal of
the school in which the child is enrolled. If the child is enrolled in
a public school, the principal shall disclose the identity of the
child to the superintendent of the school district in which the child
resides. (Section 2a of the Communicable Disease Prevention Act [410
ILCS 315/2a]). School age is defined as between ages 5 and 21 by
Section 10-20.12 of the School Code [105 ILCS 5/10-20.12] and between
ages 3 and 21 for handicapped children by the Education For All
Handicapped Children Act (20 U.S.C. Section 1412(1)(B)). Diagnosed
cases and laboratory results are reported to the Department in
accordance with the provisions of the "Control of Sexually
Transmissible Diseases Code" (77 Ill. Adm. Code 693). If the child
resides in a county or city governed by a full-time Local Health
Authority, such notification shall be the responsibility of the Local
Health Authority. In all other cases, such notification shall be
responsibility of the Department. The Local Health Authority or the
Department shall offer assistance to the principal concerning HIV, the
availability of counseling and training, and guidelines for management
of the child in the classroom.
- Upon receipt of such notice, the principal may,
as necessary, such as when a student needs medical attention or must
take medication during school attendance, or when the student's
clinical condition necessitates other such services, disclose the
identity of an infected child to the school nurse at that school, the
classroom teachers in whose classes the child is enrolled, and those
persons who, pursuant to Federal or state law, are required to decide
the placement or educational program of the child. In addition, the
principal may inform such other persons as may be necessary in the
opinion of the principal that an infected child is enrolled at that
school so long as the child's identity is not revealed. (Section 2a of
the Communicable Disease Prevention Act [410 ILCS 315/2a])
- No person to whom the child's identity is
disclosed may disclose such information to any other person except as
permitted by law (Sections 9 and 10 of the AIDS Confidentiality Act).
(Source: Amended at 22 Ill. Reg. 21994, effective
December 9, 1998)
SECTION 697.410 GUIDELINES FOR THE MANAGEMENT OF CHRONIC INFECTIOUS
DISEASES IN SCHOOL CHILDREN
The management of the child in the classroom should be in accordance
with the following guidelines developed jointly by the Department and
the State Board of Education, "Guidelines for Management of Chronic
Infectious Diseases in School Children."
SECTION 697.420 TESTING, TREATMENT OR COUNSELING OF MINORS
Any person twelve years of age or older who may have come in contact
with any STD, such as AIDS or HIV infection may consent to testing and
to medical care and/or counseling related to the diagnosis and/or
treatment of such diseases. (Section 4 of the Consent by Minors to
Medical Procedure Act [405 ILCS 210/4])
(Source: Amended at 22 Ill. Reg. 21994, effective December 9, 1998)
SECTION 697.APPENDIX A SAMPLE HIV TESTING FORMS
SECTION 697.ILLUSTRATION A SAMPLE WRITTEN INFORMED CONSENT FORM
Written Consent for HIV Antibody Testing
Test Subject or Number: Date:
Time: (AM) (PM)
I am giving my permission for a blood test in order to detect whether I
have antibodies to the HIV virus (Human Immunodeficiency virus) or any
other identified causative agent of AIDs in my blood. I understand that
the test results will be utilized for the purposes of my medical care and
treatment.
I understand that the test is performed by withdrawing a sample of my
blood and conducting laboratory tests to determine the presence of
antibodies to HIV. I understand that the results of the blood tests
considered to be positive will be reported to the Illinois Department of
Public Health.
I further understand that a positive result does not mean I have AIDS,
but that my blood has been exposed to the AIDS virus and antibodies to that
virus are present in my blood. I understand that counseling concerning
AIDS will be offered to me if my test results are found to be positive.
I have been informed and understand that test results, in a percentage
of cases, may indicate that a person has antibodies to the virus when the
person does not have the antibodies (a false positive result) or that the
test may fail to detect that a person has antibodies to the virus when the
person does in fact have these antibodies (a false negative result).
I understand that my test results will be released to my physicians and
other health care providers providing my care. In addition, I understand
that the law allows my identity and test results to be disclosed to
specific persons, such as the physicians and health care providers involved
in the use of any donated organs or tissue, and the Illinois Department of
Public Health, health care facility staff committees and research studies
(without name). I understand that my test results will be kept
confidential to the extent provided by law. I understand further that upon
my request and when permitted by law, my written consent and test result,
will be coded so as not to connect the written consent form and the test
results. In addition, I understand that I may withdraw from the testing at
any point in time, prior to the completion of laboratory tests.
My physician has advised me about the purpose, potential uses,
limitations and meaning of the test results; the voluntary nature of the
test; the right to withdraw at any time, prior to the completion of
laboratory tests; the right to anonymity; and the confidentiality
protections under the law. With the information presented above having
been completely and clearly explained to me and all of my questions having
been answered, I hereby authorize (Physician and/or Hospital or health
care facility) to test my blood for HIV infection.
(Signature or Notation of the Test Subject (Signature of Physician)
or Signature of a Legally Authorized
Representative)
Date Signed
SECTION 697.ILLUSTRATION B SAMPLE MARRIAGE LICENSE TESTING
CERTIFICATE (REPEALED)
(Source: Repealed at 15 Ill. Reg. 11646, effective August 15, 1991)
SECTION 697.APPENDIX B STATUTORY AND REGULATORY REFERENCES TO AIDS
(Repealed)
(Source: Repealed at 22 Ill. Reg. 21994, effective December 9, 1998)
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