Section 699.10  General Applicability (Repealed)

 

(Source:  Repealed at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.20  Definitions

 

"Act" means the Perinatal HIV Prevention Act [410 ILCS 335].

 

"AIDS" means acquired immunodeficiency syndrome. (Section 3(b) of the AIDS Confidentiality Act)

 

"Antiretroviral Preventive Treatment" means a well-established method of preventing vertical HIV transmission.

 

"Department" means the Department of Public Health.  (Section 5 of the Act)

 

"Health Care Facility" or "Facility" means any hospital or other institution that is licensed or otherwise authorized to deliver health care services. (Section 5 of the Act)

 

"Health Care Professional" means a physician licensed to practice medicine in all its branches, a physician assistant who has been delegated the provision of health services by his or her supervising physician, or an advanced practice registered nurse who has a written collaborative agreement with a collaborating physician that authorizes the provision of health services.  (Section 5 of the Act)

 

"Health Care Services" means any prenatal medical care or labor or delivery services to a pregnant woman and her newborn infant, including hospitalization. (Section 5 of the Act)

 

"HIV" means the human immunodeficiency virus or any other identified causative agent of AIDS. (Section 3(c) of the AIDS Confidentiality Act)

 

"HIV Test" means an HIV test method approved by the federal Food and Drug Administration (FDA) or validated under a laboratory's Clinical Laboratory Improvement Amendments (CLIA) certification.

 

"Informed Consent" means a written or verbal agreement by the subject of a test or the subject's legally authorized representative obtained without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion.

 

"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 12,

 

Deceased,

 

Declared incompetent by a court of law, or

 

Otherwise not competent to consent (for reasons other than age, such as lacking decisional capacity) as determined by the health care professional seeking 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, except as limited by Section 9(k) of the AIDS Confidentiality Act providing limitations on the ability of a parent or legal guardian to receive the child's test results, and Sections 4 and 5 of  the Consent by Minors to Medical Procedures Act [410 ILCS 210] regarding release of test results involving a sexually transmitted infection,

 

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 or other court-appointed personal representative,

 

Spouse or person in a civil union,

 

Adult children,

 

Parent,

 

Adult next-of-kin.

 

"Perinatal" means  relating to or during the period around childbirth, especially the five months before and one month after birth.

 

"Physician" means a physician licensed to practice medicine under the Medical Practice Act of 1987 [225 ILCS 60].

 

"Rapid HIV Test" means any test approved by the FDA or validated under a laboratory's CLIA certification for the detection of HIV that can be collected and processed within 60 minutes. 

 

"Supplemental Test" means any HIV test approved by the FDA or validated under a laboratory's CLIA certification used to confirm the positive result of a screening test.

 

"Vertical Transmission" means transmission of a pathogen such as HIV from mother to fetus or baby during pregnancy or birth.

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.30  Referenced Materials

 

The following materials are referenced in this Part:

 

a)         Illinois Statutes

 

1)         AIDS Confidentiality Act [410 ILCS 305]

 

2)         Perinatal HIV Prevention Act [410 ILCS 355]

 

3)         Medical Practice Act of 1987 [225 ILCS 60]

 

4)         Civil Administrative Code of Illinois [20 ILCS 2310]

 

                        5)         Consent by Minors to Medical Procedures Act [410 ILCS 210]

 

b)         Illinois Administrative Rules

 

HIV/AIDS Confidentiality and Testing Code (77 Ill. Adm. Code 697)

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.100  Perinatal Counseling and Testing

 

a)         Every health care professional who provides health care services to a pregnant woman shall, unless she has already been tested during the current pregnancy, provide the woman with HIV counseling, as described in this Section, and shall test her for HIV as early in the pregnancy as possible, unless she refuses. (Section 10(a) of the Act)

 

b)         For women at continued risk of exposure to HIV infection in the judgment of the  health care professional, a repeat test should be recommended late in pregnancy or at the time of labor and delivery. (Section 10(a) of the Act)

 

c)         HIV counseling and testing or refusal of testing shall be documented in the woman's medical record. (Section 10(b) of the Act)

 

d)         Any testing or test results shall be conducted  in accordance with the AIDS Confidentiality Act and the HIV/AIDS Confidentiality and Testing Code and shall be documented in accordance with the AIDS Confidentiality Act  and the HIV/AIDS Confidentiality and Testing Code in the woman's medical record. (Section 10(b) of the Act)

 

e)         All HIV counseling must be provided in accordance with the AIDS Confidentiality Act and must include, at minimum, the following  information:

 

1)         For the health of the pregnant woman, the voluntary nature of the testing, the benefits of HIV testing, including the prevention of transmission, and the requirement that the HIV testing be performed unless she refuses and the methods by which she can refuse;

 

2)         The benefit of HIV testing for herself and the newborn infant, including interventions to prevent HIV transmission;

 

3)         The side effects of interventions to prevent HIV transmission;

 

4)         The statutory confidentiality provisions that relate to HIV and AIDS testing;

 

5)          The requirement for mandatory testing of the newborn if the mother's HIV status is unknown at the time of delivery;

 

6)          An explanation of the test, including its purpose, limitations, and the meaning of its results;

 

7)          An explanation of the procedures to be followed;

 

8)          The availability of additional or confirmatory testing, if appropriate.  Counseling may be provided in writing, verbally, or by video, electronic, or other means.  The woman must be offered an opportunity to ask questions about testing and to decline testing for herself. (Section 10(d) of the Act)

 

f)         Information shall also be provided concerning the following:

 

1)         HIV infection and HIV transmission;

 

2)         Methods of preventing HIV transmission; and

 

3)         The availability of referrals for further information or counseling (Section 5 of the AIDS Confidentiality Act).

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.200   HIV Counseling and Testing in Labor and Delivery

 

a)         A health care facility providing medical care for labor or delivery services to a pregnant woman and her newborn infant shall develop and follow written policies

and procedures concerning the delegation of  the responsibilities for carrying out the counseling and testing requirements of Subparts C and D of this Part. These policies and procedures shall be provided to the Department upon request. Delegation of responsibilities shall be in accordance with other personnel policies of the facility and the Act.

 

b)         Every health care professional or facility that cares for a pregnant woman during labor or delivery shall, unless she has already been tested during the current pregnancy and HIV test results are already documented in the woman's medical record, provide the woman with HIV counseling and rapid HIV testing unless she refuses, in accordance with Section 699.100(c) and (d). HIV testing shall be provided with the woman's informed consent in accordance with Section 699.100(e).  (Section 10(b) of the Act)

 

c)         The counseling and testing or refusal of testing shall be documented in the woman's labor and delivery medical record.  (Section 10(b) of the Act)

 

d)         The health care facility shall adopt a policy that provides that as soon, as possible within medical standards after the infant's birth, the mother's HIV test result, if available, shall be noted in the newborn infant's medical record. It shall also be noted in the newborn infant's medical record if the mother's HIV test result is not available because she has not been tested or has declined testing. (Section 10(b) of the Act)

 

e)         Any testing or test results shall be conducted in accordance with the AIDS Confidentiality Act and the HIV/AIDS Confidentiality and Testing Code and shall be documented in accordance with the AIDS Confidentiality Act and the HIV/AIDS Confidentiality and Testing Code in the woman's medical record. (Section 10(b) of the Act)

 

f)          In addition to the counseling information required in Section 699.100(d), when disclosing a positive result of a rapid HIV test to a pregnant woman, every health care professional or facility shall provide the woman with post-delivery follow-up referrals to physicians or facilities with experience in providing services to women with HIV.

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.300  HIV Testing of a Newborn Infant Post-Delivery

 

a)         Every health care professional or facility caring for a newborn infant shall, upon delivery or as soon as possible within medical standards after the infant's birth, provide counseling as described in Section 10(d) of the Act to the parent or guardian of the infant and perform rapid HIV testing on the infant, when the HIV status of the infant's mother is unknown.  (Section 10(c) of the Act)        

 

b)         Every health care professional or facility providing the positive result of an HIV test on a newborn infant shall provide the parent or legally authorized representative with an explanation of antiretroviral preventive treatment for HIV-exposed newborn infants.

 

c)         When the newborn infant has tested positive, the health care professional or facility providing information on antiretroviral preventive treatment for the HIV-exposed newborn infant shall explain to the mother how the test detects maternal HIV infection, offer HIV risk counseling, encourage HIV testing for the mother, and provide referrals to physicians or facilities that have experience treating women and children with HIV.

 

d)         Consent for testing of a newborn infant shall be presumed when a health care professional or health care facility seeks to perform a test on a newborn infant whose mother's HIV status is not known, provided that the counseling required under Section 10(d) of the Act, Section 699.100(d) of this Part and the AIDS Confidentiality Act. (Section 10(e) of the Act)

 

e)         Counseling required in this Subpart shall include the elements required in Section 699.100(d).                                                                            

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.400  Approved HIV Tests

 

HIV testing shall be completed in accordance with Section 697.100 of the HIV/AIDS Confidentiality and Testing Code.

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.410  Informed Consent for HIV Testing

 

No person may order an HIV test for a pregnant woman without first receiving the documented informed consent of the subject of the test or subject's legally authorized representative.  (Section 4 of the AIDS Confidentiality Act)

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.420  Test Result Disclosure

 

Release of HIV test results shall be as described in 77 Ill. Adm. Code 697.140 (HIV/AIDS Confidentiality and Testing Code). Positive results from rapid HIV tests may be released in accordance with Section 697.100 of that Code.

 

(Source:  Amended at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.500  Telephone Reporting of Positive HIV Tests

 

a)         Health care facilities shall report a preliminary positive rapid HIV test in a delivering mother or her infant within 24 hours after birth by calling the 24/7 Perinatal HIV Hotline and by submitting a Preliminary Positive Data Collection Report.

 

b)         Health care facilities reporting a preliminary positive HIV test result shall conduct supplemental testing and communicate the results by telephone to the 24/7 Perinatal HIV Hotline.

 

(Source:  Added at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.510  Reporting of Perinatal HIV Exposure

 

a)         Health care facilities shall report a case of perinatal HIV exposure using the Department's Pediatric HIV/AIDS Confidential Case Report for a person under age 13 when caring for a newborn:

 

1)         Whose mother is confirmed to be HIV positive prior to labor and delivery;

 

2)         Whose mother has a rapid HIV test result that is preliminary positive at labor and delivery, and the supplemental test results are positive; or

 

3)         Who has a rapid HIV test result that is preliminary positive at delivery, and the supplemental test results are positive.

 

b)         If, after 18 months from the date that the report was submitted, a newborn infant is determined to not have HIV or AIDS, the Department shall remove the newborn infant's name from all reports, records and files collected or created.

 

(Source:  Added at 37 Ill. Reg. 226, effective December 18, 2012)

 

Section 699.520  Monthly Reporting of Data

 

a)         Health care facilities shall report monthly aggregate statistics to the Department, including, but not be limited to, the number of:

 

1)         known positive pregnant women presenting for delivery;

 

2)         pregnant women rapidly tested for HIV in labor and delivery;

 

3)         newborn infants rapidly tested for HIV;

 

4)         preliminary HIV-positive women;

 

5)         preliminary HIV-exposed newborn infants; and

 

6)         mothers and infants successfully linked to ongoing medical care and case management services.

 

b)         Aggregate monthly data shall be reported on the Perinatal Rapid HIV Testing Monthly Report form provided by the Department, and the report shall be submitted by the tenth day of the following month.

 

c)         Health care facilities shall complete a preliminary positive data report for every case of a preliminary positive HIV result in a mother or newborn infant. Data are reported on the Preliminary Positive Rapid Data Collection form provided by the Department.  The report shall be submitted immediately following the identification of the preliminarily positive test result and resent after supplemental test results are available.

 

(Source:  Added at 37 Ill. Reg. 226, effective December 18, 2012)

Section 699.APPENDIX A   Sample Rapid HIV Testing Forms (Repealed)

 

Section 699.ILLUSTRATION A   Sample Written Refusal Form for Testing Newborn Infants (Repealed)

 

(Source:  Repealed at 37 Ill. Reg. 226, effective December 18, 2012)

Section 699.APPENDIX A   Sample HIV Testing Forms (Repealed)

 

Section 699.ILLUSTRATION B   Sample Written Informed Consent to Perform a Rapid HIV Test in the Labor and Delivery Setting (Repealed)

 

(Source:  Repealed at 37 Ill. Reg. 226, effective December 18, 2012)