CMV EDUCATION AND NEWBORN SCREENING ACT - ENACTMENT |
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Act of Jun. 27, 2022, P.L. 388, No. 29 | Cl. 35 |
An Act
Providing for cytomegalovirus education and newborn screening.
The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:
Section 1. Short title.
This act shall be known and may be cited as the CMV Education and Newborn Screening Act.
Section 2. Definitions.
The following words and phrases when used in this act shall have the meanings given to them in this section unless the context clearly indicates otherwise:
"Birthing facility." An inpatient or ambulatory health care facility licensed by the department that provides birthing and newborn care services.
"Certified nurse-midwife." An individual licensed by the State Board of Medicine to practice midwifery under section 35 of the act of December 20, 1985 (P.L.457, No.112), known as the Medical Practice Act of 1985.
"CMV." Cytomegalovirus.
"Department." The Department of Health of the Commonwealth.
"Health care practitioner." The term shall have the same meaning as defined in section 103 of the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act.
"Newborn child." A child under 21 days of age.
"Unlicensed midwife." The term shall have the same meaning as defined in section 2 of the act of September 9, 1965 (P.L.497, No.251), known as the Newborn Child Testing Act.
Section 3. Informational publications by department.
(a) General rule.--The department shall make the following available on the department's publicly accessible Internet website:
(1) Up-to-date, evidence-based information about CMV that has been reviewed by medical experts and national CMV organizations. The information provided shall include the following:
(i) The incidence of CMV.
(ii) The transmission of CMV to pregnant women and women who may become pregnant.
(iii) Birth defects caused by congenital CMV.
(iv) Methods of diagnosing congenital CMV.
(v) Available preventive measures.
(vi) Treatment options.
(vii) Any other information the department deems necessary.
(2) Contact information regarding support programs and services, including the following:
(i) Information hotlines specific to CMV.
(ii) Relevant resource centers or clearinghouses.
(iii) National and local CMV organizations.
(iv) Educational and support programs.
(b) Form.--The information provided in accordance with this act shall conform to the applicable standard or standards provided in the enhanced "National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care," as adopted by the United States Department of Health and Human Services and published in the Federal Register on September 24, 2013.
Section 4. Dissemination of information on CMV.
(a) Requirement.--A certified nurse-midwife, a health care practitioner or an unlicensed midwife that assumes responsibility for the prenatal care of a pregnant woman shall provide the educational information regarding CMV made available by the department under section 3.
(b) Compliance.--Delivery of information prepared by the department in accordance with section 3 shall constitute compliance with this section.
Section 5. CMV newborn screening.
(a) Requirement.--The department shall require a birthing facility, a certified nurse-midwife, a health care practitioner or an unlicensed midwife that assumes care of a newborn child to offer the parent or guardian of the newborn child screening for CMV, or a referral for screening for CMV, before the newborn child is 21 days of age if the newborn child fails the initial newborn hearing screening under the act of November 30, 2001 (P.L.849, No.89), known as the Infant Hearing Education, Assessment, Reporting and Referral (IHEARR) Act.
(b) Consent required.--Before a CMV screening is performed on a newborn child, a parent or guardian of the newborn child shall provide written consent to a birthing facility, a certified nurse-midwife, a health care practitioner or an unlicensed midwife that assumes care of the newborn child. The parent or guardian shall provide the written consent on a form developed by the birthing facility, certified nurse-midwife, health care practitioner or unlicensed midwife. The birthing facility, certified nurse-midwife, health care practitioner or unlicensed midwife shall include the written consent under this subsection in the medical records of the newborn child and submit a report on the medical records to the department in a manner specified by the department.
(c) Objection.--A CMV screening may not be performed on a newborn child if the parent or guardian of the newborn child objects to the CMV screening for any reason. A birthing facility, a certified nurse-midwife, a health care practitioner or an unlicensed midwife that assumes care of a newborn child shall document an objection under this subsection in writing and include the objection in the medical records of the newborn child and submit a report on the medical records to the department in a manner specified by the department.
(d) Screening.--A CMV screening shall be performed using the following:
(1) polymerase chain reaction (PCR) on saliva or urine;
(2) follow-up urine test to a positive PCR saliva test for confirmation; or
(3) testing approved on or before the effective date of this section by:
(i) the department; or
(ii) the Centers for Disease Control and Prevention.
(e) Election.--Nothing in this section shall be construed to prohibit a parent or guardian of a newborn child from electing to have the newborn child screened for CMV.
Section 6. Regulations.
Within two years of the effective date of this section, the department shall promulgate regulations necessary to effectuate the provisions of this act.
Section 7. Effective date.
This act shall take effect immediately.