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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”


   


 

Rules of the Illinois Department of Public Health
(Cite rules as follows: 2 Ill. Adm. Code 1125)

 http://www.psychpage.com/


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

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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:

  1. Illinois Statutes
    1. AIDS Confidentiality Act [410 ILCS 305],
    2. AIDS Registry Act [410 ILCS 310],
    3. The Communicable Disease Prevention [410 ILCS 315],
    4. The Unified Code of Corrections [730 ILCS 5],
    5. The Medical Patient Rights Act [410 ILCS 50],
    6. The Civil Administrative Code of Illinois [20 ILCS 2310/55 to 55.45].
  2. Illinois Rules
    1. Control of Communicable Disease Code (77 Ill. Adm. Code 690) (see in particular Section 697.140(a)(4) of this Part),
    2. 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),
    3. Illinois Clinical Laboratories Code (77 Ill. Adm. Code 450) (see in particular Section 697.180(c) and (e)),
    4. Blood Labeling Code (77 Ill. Adm. Code 460) (see in particular Section 697.180(c) and (e) of this Part),
    5. Sperm Bank and Tissue Bank Code (77 Ill. Adm. Code 470) (see in particular Section 697.180(c) and (e)),
    6. Rules of Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100) (see in particular Section 697.40 of this Part),
    7. Illinois Blood Bank Code (77 Ill. Adm. Code 490).
  3. Federal Rules 42 CFR 2a.4(a)-(j), 2a.6(a)-(b), and 2a.7(a)-(b).
  4. Other Codes, Guidelines and Standards
    1. 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.
    2. 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).
    3. 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.)
    4. Guidelines for the Management of Chronic Infectious Diseases in School Children. (See Section 697.410.)
    5. 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.
  5. All citations to federal regulations in this Part concern the specified regulations in the 1994 Code of Federal Regulations, unless another date is specified.
  6. 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

  1. 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:
    1. Enzyme-linked Immunosorbent Assay (ELISA) (screening);
    2. Western blot assay (confirmatory);
    3. Indirect fluorescent antibody test (IFA) (confirmatory);
    4. Recombinant antigen HIV-1 latex agglutination test (screening and confirmatory);
    5. Radioimmune precipitation assay (RIPA) (confirmatory);
    6. Polymerase chain reaction (PCR) test (confirmatory).
  2. Testing for the presence of antibodies to the HIV virus shall consist of the following:
    1. 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.
    2. 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.
    3. 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.
    4. 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

  1. 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:
    1. 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),
    2. The availability of additional or confirmatory testing, if appropriate (See Section 687.100(b)), and
    3. The availability of referrals for further information or counseling. (Section 5 of the AIDS Confidentiality Act).
  2. Pre-test information when ordering an HIV test is not required in the following situations:
    1. 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.)
    2. 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.)
    3. 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.)
    4. 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

  1. 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)
    1. 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.
    2. 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.
  2. Written informed consent to perform an HIV test is not required in the following situations:
    1. 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)
    2. 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)
    3. 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)
    4. 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)
    5. 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.)
    6. 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.

  1. 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.
  2. Anonymous testing shall not be permitted under the following circumstances:
    1. 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
    2. 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

  1. 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):
    1. The subject of the test or the subject's legally authorized representative (Section 9(a) of the AIDS Confidentiality Act).
    2. 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.
    3. 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)

  1. 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.
  2. 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.
    1. 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.
    2. 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.
  3. Liability and Sanctions
    1. 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)
    2. 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)

  1. 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

  1. 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.
  2. 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:
    1. Give the patient or applicant prior written notice of such requirement,
    2. Proceed with such testing only upon the written authorization of the applicant or patient, and
    3. Keep the results of such testing confidential.
  3. 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

  1. 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:
    1. 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.
    2. 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.
  2. 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.)
  3. 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.

  1. 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.
  2. If permission for HIV testing is not given, then the person shall not be accepted as a donor.
  3. 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.
  4. The results of HIV testing shall be kept confidential in accordance with the provisions of Section 697.140 of this Part.
  5. 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

  1. 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.)
  2. 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.
  3. 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

  1. The Department may not release information gathered pursuant to the AIDS Registry Act unless:
    1. It is in statistical form that does not identify the reporting entity, physician or patient in any way, including by address;
    2. 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)
  2. 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)
  3. 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)
    1. 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.
    2. 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.

  1. HIV/AIDS information may be disclosed in accordance with the provisions of Sections 697.140 and 697.400 of this Part.
  2. 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

  1. 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.)
    1. These facilities shall not be operated by blood banks, plasma centers or hospitals. (Section 55.41 of the Civil Administrative Code of Illinois)
    2. Physicians and other health care providers may refer HIV-infected persons to these facilities for counseling.
    3. Any person twelve years of age or older may consent to testing and counseling at an HIV Counseling and Testing Center.
  2. 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.)
  3. 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.
  4. 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:
    1. information about the natural history of HIV infection and HIV transmission;
    2. 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;
    3. information about the availability of referrals for further information, or counseling; and
    4. methods for prevention of transmission of HIV.
  5. Contact interview and investigation services shall be provided only by counselors who have completed a course of training which included instruction in the following:
    1. The etiology and transmission of HIV, including associated risk behaviors and activities and patient profiles of persons as significant risk of HIV infection;
    2. The natural history and progression of HIV infection;
    3. Methods for preventing transmission of HIV infection;
    4. 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;
    5. Principles and techniques of contact investigation and referral; and
    6. Principles of communicable diseases.
  6. 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.
  7. 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.
    1. 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.
    2. 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.
    3. 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.

  1. 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.
  1. 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

  1. 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.
  2. 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])
  3. 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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