SB3667 96TH GENERAL ASSEMBLY

LRB096 20261 RPM 35854 b

96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
SB3667

Introduced 2/11/2010, by Sen. William Delgado

SYNOPSIS AS INTRODUCED:

New Act

Creates the Prenatal and Neonatal Congenital Toxoplasmosis Prevention and Treatment Act. Sets forth definitions. Provides that health care professionals shall provide counseling for Toxoplasmosis and testing for T. gondii when providing care to a pregnant woman during her pregnancy, unless the woman has been diagnosed prior to the pregnancy or she refuses, and during her delivery, unless she has already been determined to be IgG positive and chronically infected or she refuses. Sets forth circumstances under which every health care professional or facility caring for a newborn infant shall provide counseling and perform Toxoplasmosis testing. Sets forth subject matter requirements for the counseling required under the Act. Provides that consent for testing of a newborn infant shall be presumed when a health care professional or facility seeks to perform a test on a newborn infant whose mother's Toxoplasmosis status is unknown, provided that mandated counseling has taken place. Provides that the Department of Public Health shall adopt necessary rules to implement the Act. Effective immediately.

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning health.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 1. Short title. This Act may be cited as the Prenatal and Neonatal Congenital Toxoplasmosis Prevention and Treatment Act.

Section 5. Definitions. In this Act:

"Acute Acquired Toxoplasmosis" means the disease caused by recent acquisition of T. gondii.

"Congenital Toxoplasmosis" means an infection of a fetus or newborn infant with T. gondii. This infection occurs when a mother acquires T. gondii for the first time during pregnancy or when an immunologically compromised mother has a chronic infection and she transmits the infection to the fetus or newborn infant. Such infection may cause brain and eye damage in the fetus or infant.

"Department" means the Department of Public Health.

"Health care facility" or "facility" means any hospital or other institution that is licensed or otherwise authorized to deliver health care services.

"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 written collaborative agreements with a collaborating physician that authorizes the provision of health services.

"Health care services" means any prenatal medical care or labor delivery services to a pregnant woman and her newborn infant, including hospitalization.

"IgG" means Immunoglobulin G. A T. gondii specific IgG antibody means that the person is infected with Toxoplasma gondii.

"IgM" means Immunoglobulin M. A T. gondii specific IgM is an antibody that detects recent or acute infection with Toxoplasma gondii, this antibody can be present for years. Other specialized tests can detect whether an infection is very recent.

"Toxoplasma gondii", "T. gondii", or "Toxoplasma" means an apicomplexan parasite that can cause disease.

"Toxoplasmosis" means the disease caused by Toxoplasma gondii.

"U.S. Taxoplasmosis Reference Laboratory" means the Palo Alto Toxoplasma Serology Laboratory in Palo Alto, California. The Palo Alto Laboratory serves as the reference laboratory for the U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA). The Palo Alto Laboratory performs serologic tests that cannot be reliably completed at commercial laboratories.

Section 10. Toxoplasmosis counseling and offer of Toxoplasmosis testing required.

(a) Every health care professional who provides health care services to a pregnant woman shall, unless the woman has been diagnosed with Toxoplasma infection though serologic testing prior to the current pregnancy, provide the woman with Toxoplasmosis counseling and shall test her for T. gondii unless she refuses. The counseling and testing or refusal of testing shall be documented in the woman's medical record. A refusal may be verbal or in writing. A health care professional shall provide the counseling and recommend the testing as early in the woman's pregnancy as possible. For women who are negative for antibodies to T. gondii, IgG testing shall continue throughout pregnancy at an interval of once per month. At any time during pregnancy, if a woman who was previously negative has a positive IgG to T. gondii, then the woman shall be screened for IgM specific for T. gondii. If the IgM is positive, then a sample shall be sent to the U.S. Toxoplasmosis Reference Laboratory in Palo Alto, California for confirmation and to determine a likely date of acquisition. Expert advice will be sought for any woman who seroconverts or who is acutely infected so that treatment for her fetus or infant can be offered without delay to protect the baby from brain and eye disease due to Toxoplasma gondii.

(b) Every health care professional during labor or delivery shall, unless the woman receiving care has already been determined to be IgG positive and chronically infected prior to or during the current pregnancy, provide the woman with Toxoplasmosis counseling and Toxoplasmosis testing, unless the woman refuses. A refusal may be verbal or in writing. The counseling and testing or refusal of testing shall be documented in the woman's medical record. 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 Toxoplasmosis 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 Toxoplasmosis test result is not available because she has not been tested or has declined testing. Any testing or test results shall be documented in accordance with current standards of patient confidentiality.

(c) 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 to the parent or guardian of the infant and perform Toxoplasmosis testing on the infant when the Toxoplasmosis status of the infant's mother is negative in the best prepregnancy test or unknown or when there is evidence of acute acquired gestational T. gondii infection.

(d) Every health care professional or facility caring for a mother at one month postpartum shall provide counseling and perform Toxoplasmosis testing when her Toxoplasmosis status is negative or unknown.

(e) If the mother is not tested as described in subsection (d) of this Section, then every health care professional or facility caring for a newborn infant at one month of age shall provide counseling to the parent or guardian of the infant and perform Toxoplasmosis testing on the infant when the Toxoplasmosis status of the infant's mother is negative or unknown.

(f) The counseling required under this Section must be provided in accordance with the federal Health Insurance Portability and Accountability Act and must include all of the following:

(1) For the health of the pregnant woman, the voluntary nature of the testing, the benefits of Toxoplasmosis testing, including prevention of acquisition and treatment, and the requirement that Toxoplasmosis testing be performed unless she refuses and the methods by which she can refuse.

(2) The benefit of Toxoplasmosis testing for herself and the newborn infant, including interventions and treatment to prevent Toxoplasmosis.

(3) The side effects of interventions to prevent and treat Toxoplasmosis.

(4) The requirement for mandatory testing of the newborn if the mother's Toxoplasmosis status is unknown at the time of delivery.

(5) An explanation of the test, including its purpose, limitations, and the meaning of its results.

(6) An explanation of the procedures to be followed.

(7) 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.

(g) 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 Toxoplasmosis status is unknown, provided that mandated counseling has taken place.

(h) The Department of Public Health shall adopt necessary rules to implement this Act.

Section 99. Effective date. This Act takes effect upon becoming law.