HOUSE AMENDED
PRIOR PRINTER'S NOS. 812, 1088
PRINTER'S NO. 1761
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No.
709
Session of
2021
INTRODUCED BY TOMLINSON, MARTIN, MENSCH, FONTANA, DiSANTO,
STEFANO, SABATINA, KEARNEY, AUMENT, COSTA, SANTARSIERO,
COLLETT, L. WILLIAMS, TARTAGLIONE, HAYWOOD AND COMITTA,
MAY 25, 2021
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
JUNE 14, 2022
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
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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.
"Direct-entry midwife." An independent practitioner educated
in the discipline of midwifery through self-study,
apprenticeship, a midwifery school or a college or university-
based program distinct from the discipline of nursing. The term
includes certified professional midwives, traditional midwives,
Amish, Mennonite or Plain midwives and other specific cultural
or spiritual community-based midwives not licensed by the State
Board of Medicine as a certified-nurse midwife.
"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.
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(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, direct-entry
midwife or A health care practitioner OR AN UNLICENSED MIDWIFE
that assumes responsibility for the prenatal care of a pregnant
woman or a woman who may become pregnant 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.
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(a) General rule.--Except as provided for in subsection
(c), the department shall require a birthing facility or a
certified-nurse midwife, direct-entry midwife or health care
practitioner that assumes care of a newborn child to screen the
newborn child for CMV before the newborn child is 21 days of age
if:
(1) 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; or
(2) the parent or guardian of a newborn child requests
that the newborn child be screened for CMV.
(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
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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.
(b) (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.
(c) Exception.--A screening under subsection (a) may not be
performed if a parent or guardian of the newborn child dissents
on the grounds that the screening conflicts with a religious
belief or practice.
(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.
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The 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 in 90 days IMMEDIATELY.
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