Organizations Submit Public Comments for Proposed Rules for the Illinois Perinatal HIV Prevention Code

June 27, 2005

Ms. Susan Meister
Division of Legal Services
Illinois Department of Public Health
535 West Jefferson, Fifth Floor
Springfield IL 62761

RE: Notice of Proposed Rules,
Perinatal HIV Prevention Code, p. 55


Dear Ms. Meister:

In response to the draft notice of proposed Perinatal HIV Prevention Code, released in the Illinois Register on May 13, 2005, the undersigned organizations are pleased to provide comments.

We commend the Illinois Department of Public Health (IDPH) for implementing statewide the Perinatal HIV Prevention Act, which HIV/AIDS advocates helped to draft in 2003. The law has been incredibly successful. Thanks to funding IDPH provided to the Perinatal Rapid Testing Implementation in Illinois (PRTII) initiative, all birthing hospitals will be following the law by the end of June 2005. By April 2005, over 21,000 women had been tested for HIV before giving birth, and the few newborns who were identified as HIV-exposed have received appropriate therapy. In time, the policies required by this act will help us to eradicate mother-to-child HIV transmission in Illinois.

Despite these successes, we have a number of recommendations to improve the draft rules.

• Subpart A, Definition of healthcare provider (p. 6861): The definition of "health care professional" in this law and in the proposed rules is overly restrictive and does not reflect actual hospital practices nor the intent of the original authors of the legislation. Nowhere else in statute, in Illinois or nationally, does a person providing rapid or standard HIV testing need to be a physician, physician assistant, or advance practice registered nurse. IDPH's limited reading of the law is likely to result in delays in testing and counseling for mothers and newborns precisely when time is of the essence in the labor and delivery setting. The AIDS Confidentiality Act defines a health care provider as "any physician, nurse, paramedic, psychologist or other person providing medical, nursing, psychological, or other health care services of any kind. (Section 3(f), 410 ILCS 305)." Recommendation: Expand the definition to include "nurses and other certified health persons working under the direction of a doctor, as defined under the AIDS Confidentiality Act."
  
  
• Definitions (p. 6863): The definition of vertical transmission should include breastfeeding. Recommendation: After birth, add "and is inclusive of breastfeeding for the purposes of this Act."
  
  
• Subpart B, Section 699.100 (b) (p. 6863): Women who have already been tested for HIV and are at continued risk of HIV infection should also be offered a repeat test at birth. Recommendation: After pregnancy, add ", or at the time of birth."
  
  
• Subpart B, Section 699.100 (d) p. 6864: Items 6-9 were not included in the law, and were added by IDPH through rulemaking. These items were not included in PRTII training given to date, and we are concerned about the cost of re-printing flip charts and materials and retraining all birthing hospitals in the state. Furthermore, these additional items could be burdensome to providers. Recommendation: At a minimum, we recommend making these items optional. "
  
  
• Subpart C, Section 699.200 (b) (p. 6865): The proposed rule states that HIV counseling and testing should be offered to all women who present at a labor and delivery setting without a documented test result. However, the proposed rule does not say when testing and counseling must be offered. Hospital staff need time to provide HIV counseling and testing, wait for lab results, and inform the mother of the test results. If the results are preliminary positive, AZT must be ordered and obtained from the hospital pharmacy and given to the newborn. To have the greatest chance of preventing HIV infection in the newborn, research shows that the newborn must receive antiretroviral treatment as soon as possible after birth. Recommendation: To give adequate time to obtain appropriate medication, in 699.200 (b), after "Part", add "as soon as possible after the woman presents at the facility."
  
  
• Subpart C, Section 699.200 (e), p. 6865; Subpart D, Section 699.300 (b) (1) and (2), p.6866: When a rapid HIV test is used, the rules must clearly differentiate between preliminary and confirmatory testing. Recommendation: The word "preliminarily" should be added before "positive" in the second line. It should read "…when disclosing a preliminarily positive result of a rapid HIV test…"
  
  
• Subpart D, Section 699.300 (a), p. 6866: Again, this section should emphasize that counseling and a written opt-out must be provided immediately after birth because research documents that the earlier the medication is provided, the greater the likelihood that the newborn will not acquire HIV infection. Recommendation: Before "Immediately," add "In recognition of current U.S. Public Health Service and international guidelines for the prevention of perinatal HIV transmission, treatment should be started as soon as possible."
  
  
• Subpart D, Section 699.300 (b), p. 6866. It is important for the mother to understand the rapid HIV test, and know that although the results are preliminarily positive, treatment should begin anyway. Recommendation: After "antibodies," add "the limits of the rapid HIV test, explain that antiretroviral treatment must be started immediately, and will be stopped if a negative confirmatory test result is received."
  
  
• Subpart E, Section 699.410: The heading appears to have a typo. We believe it should read "informed", not "informal."
  
  
• Forms (p.6868): In general, the model forms are too long. We are concerned that a mother or guardian presented with the forms will be disinclined to sign them simply because they are long and complex. Moreover, the forms should be written so that a person with a 6th grade reading level (medical standard) can understand them. PRTII has developed sample forms (attached), which we believe are more appropriate. Specific comments are below.
  
  
• Written refusal of HIV antibody testing for a newborn infant form (p. 6868): Anonymous testing is not provided for in this law, and is not appropriate in this setting. A woman who wishes to have an anonymous test should be referred to a local health department or other testing site where anonymous testing is offered. Recommendation: "Test subject or number" should be changed to "Name."
  
  
• Mother's HIV status in newborn's record: IDPH proposes requiring the mother to sign a separate consent to place her HIV test results in the newborn's medical record. This requirement was added by IDPH and is not in the law. We believe requiring a separate consent is a significant barrier to appropriate newborn care, and could result in the baby not receiving needed treatment.
  
  Because the infant is born with the mother's antibodies and HIV status, the baby will be HIV-positive at birth if the mother is HIV-positive. The mother's HIV status must be documented in the infant's chart so health professionals can provide proper care. Without documentation of maternal status in the newborn's chart, there is no prompt for infant testing and/or treatment. Proper care of the newborn is predicated on this information.
  
  If the mother consents to an HIV test, but must separately consent to having the results placed in the newborn's chart, there is little point to testing for HIV. The infant may be denied care to prevent HIV infection.
  
  Recommendation: PRTII's model consent informs the mother that "the test results will be recorded in my medical record and my baby's medical record." The model form avoids a separate consent, while still informing the mother of hospital practices.
  
  
• Written informed consent to perform a rapid HIV test in the labor and delivery setting (P. 6871): Anonymous testing is not provided for in this law, and is not appropriate in this setting. A woman who wishes to have an anonymous test should be referred to a local health department or other testing site where anonymous testing is offered. Recommendation: "Test subject or number" should be changed to "Name."
  
  
• Consent form, p. 6873: The sample form provided by IDPH says that "The test…will provide me and my health care provider with results within 12 hours." The 12-hour timeframe for results is too long. This timeframe contradicts IDPH's own definition of a rapid HIV test as a test that will give results within 1 hour (77 Ill. Adm. Code 697.20). Allowing hospitals 12 hours to deliver results will unnecessarily delay the initiation of treatment to the newborn, reducing the chance of HIV infection being prevented. Recommendation: Twelve hours should be changed to one hour.

Thank you for the opportunity to comment on the proposed rules. If you have questions or would like additional information, please contact John Peller at the AIDS Foundation of Chicago at (312) 922-2322.

Sincerely,

John Peller
Director of State Affairs
AIDS Foundation of Chicago
411 S. Wells Street
Chicago, IL 60607

Ann Hilton Fisher
Executive Director
AIDS Legal Council of Chicago
188 W. Randolph, Ste. 2400
Chicago, IL 60601

Brad McLaughlin
Executive Director
Better Existence with HIV
1740 Ridge Avenue
Evanston, IL 60201

Brigid Leahy
Vice President
Illinois Planned Parenthood Council
1000 East Washington
Springfield, IL 62703

David Roesler
Executive Director
Open Door Clinic
164 Division Street, Suite 607
Elgin, IL 60120

Pat Garcia, MD MPH
Executive Director
Pediatric AIDS Chicago Prevention Initiative
2300 Children's Plaza Box 154
Chicago, IL 60614

Laura Gerard
Policy Associate
TASC, Inc.
1500 N. Halsted Street
Chicago, IL 60622

Jill Garcia
The Night Ministry
4711 N. Ravenswood
Chicago, Il 60640

Perinatal HIV Prevention

Testimony on Implementation of the Perinatal HIV Prevention Act