S.F. 68 Section 1. NEW SECTION . 136A.5B Cytomegalovirus public 1 health initiative —— congenital cytomegalovirus screening —— 2 public education and awareness program. 3 1. a. As used in this section, “congenital cytomegalovirus” 4 means cytomegalovirus acquired by an infant before birth. 5 b. A birthing hospital, a birth center, or an attending 6 health care provider shall ensure that the parent of every 7 newborn under the birthing hospital’s, birth center’s, or 8 attending health care provider’s care receives information 9 regarding congenital cytomegalovirus, including the symptoms 10 of and birth defects caused by congenital cytomegalovirus, the 11 opportunity for screening prior to and after being discharged 12 from the birthing hospital’s, birth center’s, or attending 13 health care provider’s care, and follow-up measures to detect 14 and treat congenital cytomegalovirus. 15 c. A birthing hospital, a birth center, or an attending 16 health care provider shall ensure that every newborn delivered 17 in a birthing hospital or birth center who fails the initial 18 newborn hearing screening administered pursuant to section 19 135.131, receives a congenital cytomegalovirus saliva 20 screening and that the newborn’s parent receives the results 21 of that screening prior to being discharged from the birthing 22 hospital’s, birth center’s, or attending health care provider’s 23 care. 24 d. A primary care provider who undertakes primary 25 pediatric care of a newborn delivered in a location other 26 than a birthing hospital or birth center shall ensure that 27 every newborn who fails the initial newborn hearing screening 28 administered pursuant to section 135.131 receives a congenital 29 cytomegalovirus saliva screening and that the newborn’s parent 30 receives the results of that screening in accordance with rules 31 adopted under this subsection. 32 e. If the results of the congenital cytomegalovirus 33 screening are positive, the parent of the newborn shall be 34 provided with information regarding options for minimizing the 35 -1- LSB 1378XS (9) 87 pf/nh 1/ 9

S.F. 68 effects of congenital cytomegalovirus, and the early follow-up 1 and intervention options, treatment, and resources available 2 for the newborn, including but not limited to those available 3 through the local birth-to-three coordinator or similar 4 agency, the local area education agency, and local health care 5 professionals. 6 f. If the results of the congenital cytomegalovirus 7 screening are negative, the parent of the newborn shall be 8 provided with information regarding follow-up program resources 9 to confirm whether the newborn has hearing loss and to provide 10 for early intervention. 11 g. The provisions of this subsection relating to a required 12 congenital cytomegalovirus saliva screening do not apply if a 13 parent objects to the screening. If a parent objects to the 14 screening of a newborn, the birthing hospital, birth center, 15 attending health care provider, or primary care provider shall 16 document the refusal in the newborn’s medical record and shall 17 obtain a written refusal from the parent and report the refusal 18 to the department. 19 h. The results of a congenital cytomegalovirus screening 20 shall be reported in a manner consistent with the reporting of 21 the results of metabolic screenings pursuant to section 136A.5, 22 and in accordance with rules adopted pursuant to section 23 136A.8. 24 i. The department may share the congenital cytomegalovirus 25 screening results information reported under paragraph “h” with 26 agencies and persons involved with newborn and infant hearing 27 screenings, follow-up services, and intervention services. 28 j. This subsection shall be administered in accordance with 29 rules adopted pursuant to section 136A.8. 30 2. a. In accordance with the duties prescribed in section 31 136A.3, the center for congenital and inherited disorders 32 shall collaborate with state and local health agencies 33 and other public and private organizations to develop and 34 publish or approve and publish informational materials to 35 -2- LSB 1378XS (9) 87 pf/nh 2/ 9

S.F. 68 educate and raise awareness of cytomegalovirus and congenital 1 cytomegalovirus among women who may become pregnant, expectant 2 parents, parents of infants, birthing hospitals, birth centers, 3 attending health care providers, primary care providers, 4 and others, as appropriate. The materials shall include 5 information regarding all of the following: 6 (1) The incidence of cytomegalovirus and congenital 7 cytomegalovirus. 8 (2) The transmission of cytomegalovirus to a pregnant woman 9 or a woman who may become pregnant. 10 (3) Birth defects caused by congenital cytomegalovirus. 11 (4) Methods of diagnosing congenital cytomegalovirus. 12 (5) Available preventive measures to avoid cytomegalovirus 13 infection by women who are pregnant or who may become pregnant. 14 (6) Early interventions, treatment, and services available 15 for children diagnosed with congenital cytomegalovirus. 16 b. An attending health care provider shall provide to a 17 pregnant woman during the first trimester of the pregnancy, 18 the informational materials published under this subsection. 19 The center for congenital and inherited disorders shall make 20 the informational materials available to attending health care 21 providers upon request. 22 c. The department shall publish the informational materials 23 on its internet site. 24 Sec. 2. Section 135.131, subsections 3, 4, and 5, Code 2017, 25 are amended to read as follows: 26 3. a. A birthing hospital shall screen every newborn 27 delivered in the hospital for hearing loss within a time frame 28 consistent with the time frame required to comply with the 29 screening for congenital cytomegalovirus pursuant to section 30 136A.5B and prior to discharge of the newborn from the birthing 31 hospital. A birthing hospital that transfers a newborn for 32 acute care prior to completion of the hearing screening shall 33 notify the receiving facility of the status of the hearing 34 screening. The receiving facility shall be responsible for 35 -3- LSB 1378XS (9) 87 pf/nh 3/ 9

S.F. 68 completion of the newborn hearing screening and the congenital 1 cytomegalovirus screening pursuant to section 136A.5B . 2 b. The birthing hospital or other facility completing 3 the hearing screening under this subsection shall report the 4 results of the screening to the parent or guardian of the 5 newborn and to the department in a manner prescribed by rule of 6 the department. The birthing hospital or other facility shall 7 also report the results of the hearing screening to the primary 8 care provider of the newborn or infant upon discharge from the 9 birthing hospital or other facility. If the newborn or infant 10 was not tested prior to discharge, the birthing hospital or 11 other facility shall report the status of the hearing screening 12 and congenital cytomegalovirus screening pursuant to section 13 136A.5B to the primary care provider of the newborn or infant. 14 4. A birth center shall refer the newborn to a licensed 15 audiologist, physician, or hospital for screening for 16 hearing loss within a time frame consistent with the time 17 frame required to comply with the screening for congenital 18 cytomegalovirus pursuant to section 136A.5B and prior to 19 discharge of the newborn from the birth center. The hearing 20 screening shall be completed within thirty days following 21 discharge of the newborn. The person completing the hearing 22 screening shall report the results of the screening to the 23 parent or guardian of the newborn and to the department in a 24 manner prescribed by rule of the department. Such person shall 25 also report the results of the screening to the primary care 26 provider of the newborn. 27 5. If a newborn is delivered in a location other than a 28 birthing hospital or a birth center, the physician or other 29 health care professional who undertakes the pediatric care of 30 the newborn or infant shall ensure that the hearing screening 31 is performed within three months of the date of the newborn’s 32 or infant’s birth a time frame consistent with the time frame 33 required by rule to comply with the screening for congenital 34 cytomegalovirus pursuant to section 136A.5B . The physician or 35 -4- LSB 1378XS (9) 87 pf/nh 4/ 9

S.F. 68 other health care professional shall report the results of the 1 hearing screening to the parent or guardian of the newborn or 2 infant, to the primary care provider of the newborn or infant, 3 and to the department in a manner prescribed by rule of the 4 department. 5 Sec. 3. Section 136A.2, Code 2017, is amended by adding the 6 following new subsections: 7 NEW SUBSECTION . 1A. “Birth center” means birth center as 8 defined in section 135.61. 9 NEW SUBSECTION . 1B. “Birthing hospital” means a private 10 or public hospital licensed pursuant to chapter 135B that has 11 a licensed obstetric unit or is licensed to provide obstetric 12 services. 13 NEW SUBSECTION . 7A. “Primary care provider” means a health 14 care provider who undertakes primary pediatric care of a 15 newborn delivered in a location other than a birthing hospital 16 or birth center. 17 Sec. 4. ADOPTION OF RULES. The rules adopted by the 18 department of public health pursuant to section 136A.8 as 19 directed in this Act shall include all of the following: 20 1. Protocols for the saliva screening for congenital 21 cytomegalovirus. 22 a. The protocols shall ensure that if the newborn is 23 delivered in a birthing hospital or birth center, any 24 saliva specimen required for the screening is collected 25 within twenty-four hours of the newborn’s birth, and that an 26 appropriate lab receives and processes the specimen and reports 27 the results of the processing to the birthing hospital, birth 28 center, or attending health care provider within twenty-four 29 hours of receipt of the specimen by the lab. 30 b. The protocols shall ensure that if the newborn is 31 delivered in a location other than a birthing hospital or 32 birth center, the saliva specimen required for screening is 33 collected, and the appropriate lab receives and processes the 34 specimen and reports the results of the processing to the 35 -5- LSB 1378XS (9) 87 pf/nh 5/ 9

S.F. 68 primary care provider within the time frame specified by rule. 1 2. Protocols for determining whether a birthing hospital, a 2 birth center, an attending health care provider, or a primary 3 care provider is responsible for completion of the congenital 4 cytomegalovirus screening process for a newborn, depending upon 5 the circumstances of the birth. 6 3. The specific obligations of the birthing hospital, 7 birth center, attending health care provider, primary care 8 provider, lab, and other persons involved in the congenital 9 cytomegalovirus screening process. 10 4. Provisions related to the sharing by the department of 11 congenital cytomegalovirus screening results information with 12 agencies and persons involved with newborn and infant hearing 13 screenings, follow-up services, and intervention services to 14 protect the confidentiality of the individuals involved. 15 Sec. 5. CYTOMEGALOVIRUS EDUCATION PROGRAM GRANT —— 16 APPROPRIATION. There is appropriated from the general fund of 17 the state to the department of public health for the fiscal 18 year beginning July 1, 2017, and ending June 30, 2018, the 19 following amount or so much thereof as is necessary for the 20 purpose designated: 21 For a grant awarded through a request for proposals process 22 to an Iowa-based nonprofit prenatal education program to assist 23 maternal health care providers in educating women who may 24 become pregnant, expectant parents, and parents of infants 25 about the strategies to prevent, the risks presented by, and 26 the minimization of the effects of congenital cytomegalovirus: 27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $ 100,000 28 EXPLANATION 29 The inclusion of this explanation does not constitute agreement with 30 the explanation’s substance by the members of the general assembly. 31 This bill creates a cytomegalovirus public health initiative 32 including congenital cytomegalovirus (CMV) screening 33 requirements and a public education and awareness program. 34 The bill requires a birthing hospital, birth center, or 35 -6- LSB 1378XS (9) 87 pf/nh 6/ 9

S.F. 68 attending health care provider to ensure that the parent of 1 every newborn under the birthing hospital’s, birth center’s, 2 or attending health care provider’s care receives information 3 regarding congenital CMV, including the symptoms of and 4 birth defects caused by congenital CMV, the opportunity for 5 screening prior to and after being discharged from the birthing 6 hospital’s, birth center’s, or attending health care provider’s 7 care; and follow-up measures to detect and treat congenital 8 CMV. 9 The bill requires a birthing hospital, birth center, or 10 attending health care provider to ensure that every newborn 11 delivered in a birthing hospital or birth center who fails the 12 initial newborn hearing screening receives a congenital CMV 13 saliva screening and that the parent of the newborn receives 14 the results of the screening prior to being discharged from 15 the birthing hospital’s, birth center’s, or attending health 16 care provider’s care. The bill requires similar duties of a 17 primary care provider who undertakes primary pediatric care 18 of a newborn delivered in a location other than a birthing 19 hospital or birth center. If the results of the congenital 20 CMV screening are positive, the parent of the newborn shall 21 be provided with information regarding options for minimizing 22 the effects of congenital CMV and the early follow-up and 23 intervention options, treatment, and resources available for 24 the newborn. If the results of the congenital CMV screening 25 are negative, the parent is to be provided with information 26 regarding follow-up program resources to confirm whether the 27 newborn has hearing loss and to provide for early intervention. 28 The bill provides that the required congenital CMV saliva 29 screening does not apply if a parent objects to the screening. 30 If a parent objects to the screening of a newborn, the birthing 31 hospital, birth center, attending health care provider, 32 or primary care provider shall document the refusal in the 33 newborn’s medical record and shall obtain a written refusal 34 from the parent and report the refusal to the department of 35 -7- LSB 1378XS (9) 87 pf/nh 7/ 9

S.F. 68 public health. 1 Under the bill, the results of a congenital CMV screening 2 shall be reported in a manner consistent with the reporting 3 of the results of metabolic screenings and in accordance with 4 rules adopted by the center for congenital and inherited 5 disorders with the assistance of the department of public 6 health. The bill is also to be administered in accordance with 7 those rules. 8 The bill also requires the center for congenital and 9 inherited disorders, in collaboration with state and local 10 health agencies and other public and private organizations, 11 to develop and publish or approve and publish informational 12 materials to educate and raise awareness of CMV and congenital 13 CMV among women who may become pregnant, expectant parents, 14 parents of infants, birthing hospitals, birth centers, 15 attending health care providers, primary care providers, and 16 others, as appropriate. An attending health care provider is 17 required to provide the informational materials to a pregnant 18 woman during the first trimester of the pregnancy, and the 19 center for congenital and inherited disorders is required to 20 make the informational materials available to attending health 21 care providers upon request. The department of public health 22 is required to publish the informational materials on its 23 internet site. 24 The bill provides that the rules adopted under the bill shall 25 include protocols for the saliva screening for congenital CMV, 26 depending upon the location of the delivery of the newborn. 27 The protocols are also to determine whether a birthing 28 hospital, a birth center, an attending health care provider, 29 or a primary care provider is responsible for completion of 30 the congenital CMV screening of a newborn depending upon the 31 circumstances of the birth as well as the specific obligations 32 of the birthing hospital, birth center, attending health 33 care provider, primary care provider, lab, and other persons 34 involved in the congenital CMV screening process. 35 -8- LSB 1378XS (9) 87 pf/nh 8/ 9

S.F. 68 The bill makes conforming changes to the universal newborn 1 and infant hearing screening section of the Code. 2 The bill appropriates $100,000 from the general fund of the 3 state to the department of public health for FY 2017-2018 for a 4 grant to an Iowa-based nonprofit prenatal education program to 5 assist maternal health care providers in educating women who 6 may become pregnant, expectant parents, and parents of infants 7 about the risks of, strategies to prevent, and minimization of 8 the effects of congenital cytomegalovirus. 9 -9- LSB 1378XS (9) 87 pf/nh 9/ 9