(1) (a) Repealed.
(b) Infants born in the state of Colorado shall be tested for the following conditions: Phenylketonuria, hypothyroidism, abnormal hemoglobins, galactosemia, cystic fibrosis, biotinidase deficiency, and such other conditions as the state board may determine meet the criteria set forth in subsection (1)(c) of this section. The birthing facility where the infant is born shall forward all appropriate specimens to the laboratory operated or designated by the department. The physician, nurse, midwife, or other health professional attending a birth outside a birthing facility is responsible for collecting and forwarding the specimens. The laboratory shall forward the results of the testing directly to the physician, primary care provider, or other health-care provider as needed for the provision of such information to the parent, parents, or guardians of the child. The results of any testing or follow-up testing pursuant to section 25-4-1004.5 may be sent to the immunization tracking system authorized by section 25-4-2403 and accessed by the physician or other primary health-care provider. The state board may discontinue testing for any condition listed in this subsection (1)(b) if, upon consideration of criteria set forth in subsection (1)(c) of this section, the state board finds that the public health is better served by not testing infants for that condition. Testing under this subsection (1)(b) is not required if the parent or legal guardian objects.
(c) The state board shall use the following criteria to determine whether to test infants for conditions that are not specifically enumerated in this subsection (1):
(I) The condition for which the test is designed presents a significant danger to the health of the infant or his family and is amenable to treatment;
(II) The incidence of the condition is sufficiently high to warrant screening;
(III) The test meets commonly accepted clinical standards of reliability, as demonstrated through research or use in another state or jurisdiction; and
(IV) The cost-benefit consequences of screening are acceptable within the context of the total newborn screening program.
(1.5) If the department deems that new conditions for which an infant must be tested should be added, the department shall report the added conditions to the general assembly during its presentation in accordance with the State Measurement for Accountable, Responsive, and Transparent (SMART) Government Act, part 2 of article 7 of title 2. The department shall also notify the joint budget committee and the health and human services committee of the senate and the health, insurance, and environment committee and the public health care and human services committee of the house of representatives, or their successor committees, within sixty days after the department recommends a new condition and include the added conditions in the department's annual budget request submitted to the general assembly each November 1.
(2) The executive director of the department of public health and environment shall assess a fee that is sufficient to cover the direct and indirect costs of the testing required by this section and to accomplish the other purposes of this part 10. Birthing facilities may assess a reasonable fee to be charged the parent, parents, or guardians of the infant to cover the costs of handling the specimens, the reimbursement of laboratory costs, and the costs of providing other services, including the connection of follow-up services and care to infants identified as at risk through screening, necessary to implement the purposes of this part 10.
(3) The state board shall promulgate rules concerning the requirements of the newborn screening program for genetic and metabolic disorders, including:
(a) In addition to those conditions listed in subsection (1)(b) of this section, any other conditions for which testing must occur;
(b) Obtaining samples or specimens from newborn infants required for the tests prescribed by the state board; and
(c) The handling and delivery of samples or specimens for testing and examination.
Source: L. 81: Entire part added, p. 1302, � 1, effective July 1. L. 83: (2) amended, p. 1070, � 1, effective May 20. L. 87: (1) amended, p. 1128, � 1, effective July 1. L. 88: (1) amended, p. 1009, � 1, effective July 1. L. 91: (1) amended, p. 949, � 17, effective May 6. L. 94: (1)(b) and (2) amended, p. 2769, � 456, effective July 1. L. 96: (1)(b) amended, p. 1107, � 1, effective July 1. L. 2007: (1)(b) amended, p. 654, � 2, effective April 26. L. 2018: (1)(b), IP(1)(c), and (2) amended and (1.5) and (3) added, (HB 18-1006), ch. 368, p. 2214, � 4, effective July 1.
Editor's note: Subsection (1)(a)(II) provided for the repeal of subsection (1)(a), effective April 1, 1989. (See L. 88, p. 1009.)
Cross references: For the legislative declaration contained in the 1994 act amending subsections (1)(b) and (2), see section 1 of chapter 345, Session Laws of Colorado 1994.
25-4-1004.3. Newborn heart defect screening - pulse oximetry - rules - definition. (1) (a) On and after January 1, 2016, a birthing facility that is below seven thousand feet of elevation shall test all infants born in the facility for critical congenital heart defects using pulse oximetry.
(b) Upon receipt of the confirmation of the appropriate algorithm for the pulse oximetry reading from the newborn screening committee, the newborn screening committee shall evaluate whether pulse oximetry testing in birthing facilities at or above seven thousand feet elevation meets the criteria in section 25-4-1004. Upon confirmation from the committee that the criteria have been met, the state board of health shall promulgate rules to ensure that all newborns born at or above seven thousand feet elevation are screened for critical congenital heart defects.
(c) The critical congenital heart defect screening using pulse oximetry must be performed on every newborn prior to the newborn's release from the birthing facility.
(2) Each birthing facility shall report the results of the pulse oximetry screenings to the department of public health and environment. The state board of health may promulgate rules for the implementation of this section.
(3) As used in this section, a birthing facility means a general hospital or birthing center licensed or certified pursuant to section 25-1.5-103 and that provides birthing and newborn care services.
Source: L. 2015: Entire section added, (HB 15-1281), ch. 241, p. 893, � 2, effective August 5. L. 2016: (1)(b) amended, (SB 16-189), ch. 210, p. 770, � 61, effective June 6.
Cross references: For the legislative declaration in HB 15-1281, see section 1 of chapter 241, Session Laws of Colorado 2015.
25-4-1004.5. Follow-up testing and treatment - second screening - fee - rules.
(1) Repealed.
(2) (a) Repealed.
(b) The executive director of the department shall increase the newborn screening fee as provided in section 25-4-1004 (2) so that the fee is sufficient to include the costs of providing first and second specimen tests with second-tier testing if necessitated by the results of the screening in order to reduce the number of false positive tests and to provide follow-up and referral services to families with a newborn whose test results under a newborn screening indicate a genetic or metabolic disorder.
(c) The state board shall promulgate rules to establish and maintain appropriate follow-up services on positive screen cases in order that measures may be taken to prevent death or intellectual or other permanent disabilities. The follow-up services must include identification of newborns at risk for genetic and metabolic conditions, coordination among medical providers and families, connecting newborns who screen positive to timely intervention and appropriate referrals to specialists for follow-up and diagnostic testing, and additional duties as determined by the department.
(3) (a) Infants born in the state of Colorado who receive newborn screening pursuant to section 25-4-1004 (1) must have a second specimen taken to screen for the following conditions:
(I) Phenylketonuria;
(II) Hypothyroidism;
(III) Galactosemia;
(IV) Cystic fibrosis; and
(V) Such other conditions as the state board may determine meet the criteria set forth in section 25-4-1004 (1)(c) and require a second screening for accurate test results.
(b) The state board is authorized to promulgate rules and standards for the implementation of the second specimen testing specified in this subsection (3), including:
(I) Identification of those conditions for which a second specimen shall be required;
(II) The age of the infant at which the second screening may be administered;
(III) The method by which the parent or parents of a newborn shall be advised of the necessity for a second specimen test;
(IV) The procedure to be followed in administering the second specimen test;
(V) Any exceptions to the necessity for a second specimen test and the procedures to be followed in such cases; and
(VI) The standards of supervision and quality control that shall apply to second specimen testing.
(b.5) The laboratory operated by the laboratory services division in the department, or the laboratory designated by the department, as applicable, must remain open a minimum of six days per week every week of the year.
(c) On and after July 1, 2018, the executive director of the department of public health and environment may adjust the newborn screening fee set forth in section 25-4-1004 (2) so that the fee is sufficient to cover the costs associated with the second screening described in this subsection (3). Money in the newborn screening and genetic counseling cash funds is exempt from section 24-75-402 through July 1, 2021.
(4) The provisions of section 25-4-1003 (2) shall apply to second newborn screenings.
Source: L. 94: Entire section added, p. 833, � 1, effective April 28. L. 96: (1)(f), (3), and (4) added, p. 1108, �� 2, 3, effective July 1. L. 2018: (1) repealed, (2)(b), IP(3)(a), (3)(a)(V), IP(3)(b), and (3)(c) amended, and (2)(c) and (3)(b.5) added, (HB 18-1006), ch. 368, p. 2215, � 5, effective July 1; (1)(b) amended, (SB 18-096), ch. 44, p. 473, � 14, effective August 8.
Editor's note: (1) Subsection (2)(a)(II) provided for the repeal of subsection (2)(a), effective July 1, 1994. (See L. 94, p. 833.)
(2) Subsection (1)(b) was amended in SB 18-096, effective August 8, 2018. However, those amendments were superseded by the repeal of subsection (1) by HB 18-1006, effective July 1, 2018.
Cross references: For the legislative declaration in SB 18-096, see section 1 of chapter 44, Session Laws of Colorado 2018.
25-4-1004.7. Newborn hearing screening - advisory committee - report - rules.
(1) Repealed.
(2) (a) (I) There is hereby established an advisory committee on hearing in newborn infants for the purpose of reviewing information and statistics gathered during the newborn hearing screening program and providing recommendations to birthing facilities, other health-care institutions, the department, and the public concerning, but not necessarily limited to:
(A) Best practices for hearing screening of newborn infants, which practices must be objective and physiologically based and must not include a requirement that the initial newborn hearing screening be performed by an audiologist; and
(B) Repealed.
(C) Guidelines and best practices for reporting and the means to assure that identified children receive referral for appropriate follow-up services.
(II) The advisory committee on hearing in newborn infants must consist of at least nine members. The executive director of the department shall appoint members to the advisory committee. Members appointed to the committee must have training, experience, or interest in the area of hearing loss in children and should include representatives from rural and urban areas of the state, a parent who has a child with hearing loss, a representative of a patient and family support organization, a representative of a hospital, a representative from an organization representing culturally deaf persons, an American sign language expert who has experience in evaluation and intervention of infants and young children, and physicians and audiologists with specific expertise in hearing loss in infants.
(III) The members of the advisory committee on hearing in newborn infants shall serve without compensation.
(IV) Repealed.
(b) Repealed.
(3) (a) It is the intent of the general assembly that infants born in the state be screened for hearing loss using procedures recommended by the advisory committee on hearing in newborn infants, created in subsection (2) of this section. Toward that end, every licensed or certified birthing facility shall educate the parents of infants born in such birthing facilities of the importance of screening the hearing of newborn infants and follow-up care. Education is not considered a substitute for the hearing screening described in this section. Screening for hearing loss under this subsection (3)(a) is not required if the parent or legal guardian objects.
(b) and (c) Repealed.
(4) (a) Repealed.
(b) Such rules, if promulgated, shall address those hospitals with a low volume of births, as determined by the state board of health based upon recommendations by the advisory committee on hearing in newborn infants, which may arrange otherwise for newborn infant hearing screening.
(5) A physician, nurse, midwife, or other health professional attending a birth outside a hospital or institution shall make every professional effort, as defined by the board, including following up at scheduled postpartum appointments, to ensure that the hearing screening is performed within thirty days of the birth and shall provide information, as established by rule of the department, to parents regarding the importance of the screening. The physician, nurse, midwife, or other health professional who performs the screening shall provide a report of any screening to the parent or guardian of the infant, the primary care provider of the infant, and the department. Screening for hearing loss under this subsection (5) is not required if the parent or legal guardian objects.
(6) The department shall encourage the cooperation of county, district, and municipal public health agencies, health-care clinics, school districts, and any other appropriate resources to promote the screening of newborn infants' hearing for those infants born outside a hospital or institution.
(7) Upon receipt of sufficient financial resources in the newborn hearing screening cash fund, as determined by the department, to support a new information technology system for the purpose of managing the newborn hearing screening program, the department shall procure an information technology system and promulgate rules in order to implement the system.
(8) (a) The state board of health shall promulgate rules that require each of the following with information pertinent to this section to report the results of individual screening to the department:
(I) A birthing facility; or
(II) Another facility or provider.
(b) The rules must include a requirement that the birthing facility include the results of the hearing screening in the electronic medical record of the newborn. The information system required in subsection (7) of this section must allow the results of outpatient rescreenings to be reported to the department and to the parent or guardian of the newborn.
(9) (a) The state board of health shall promulgate rules to establish and maintain appropriate follow-up services for newborns at risk of hearing loss. The follow-up services must include identification of newborns at risk for hearing loss, coordination among medical and audiology providers and families, connecting newborns to timely intervention, appropriate referrals to specialists for follow-up and diagnostic testing, and additional duties as determined by the department.
(b) The follow-up services must provide the parents with information and resources so that the parents can, in a timely manner, locate appropriate diagnostic and treatment services for the newborn.
(c) The department shall also provide appropriate training, on a periodic basis, to birthing facilities and midwives on the department's screening program.
(d) The information gathered by the department, other than statistical information and information that the parent or guardian of a newborn allows to be released through the parent's or guardian's informed consent, is confidential. Public access to newborn patient data is limited to data compiled without the newborn's name. Audiologists and other health professionals providing diagnostic services to newborns and their families may access the information, on a newborn-specific basis, for the purpose of entering follow-up information. The information gathered in accordance with this subsection (9)(d) does not restrict the department from performing follow-up services with newborns, their parents or guardians, and health-care providers.
(10) (a) The department shall develop and publish materials on its website for use in educating and training on cytomegalovirus, referred to as CMV, that include the following:
(I) The estimated incidence of CMV;
(II) The transmission of CMV to pregnant women or women who may become pregnant;
(III) Birth defects caused by congenital CMV;
(IV) Methods of diagnosing congenital CMV;
(V) Available preventive measures to avoid the infection in women who are pregnant or may become pregnant;
(VI) Resources and evidence-based treatment as they become available for families of children born with CMV; and
(VII) Any federal or state requirements regarding testing for CMV.
(b) Subject to available appropriations, the department shall provide technical assistance and training regarding CMV to health-care facilities and health-care providers upon request.
(11) The executive director of the department may assess a fee that is sufficient to cover the ongoing direct and indirect costs of all initial newborn hearing screening and follow-up services and to accomplish the other purposes of this section, which fee shall be deposited into the newborn hearing screening cash fund created in section 25-4-1006 (3). Birthing facilities may assess a reasonable fee to be charged the parent or guardian of the newborn to cover the costs of providing services necessary to implement the purposes of this section.
Source: L. 97: Entire section added, p. 1118, � 1, effective July 1. L. 2005: (2)(a)(I), (2)(b), (3)(a), IP(3)(b), and (4)(a) amended and (2)(a)(IV), (3)(b)(I) to (3)(b)(IV), and (3)(c) repealed, p. 252, �� 3, 4, 5, effective July 1. L. 2008: (2)(b) amended, p. 1906, � 100, effective August 5. L. 2010: (6) amended, (HB 10-1422), ch. 419, p. 2096, � 102, effective August 11. L. 2013: (2)(b) repealed, (SB 13-163), ch. 79, p. 252, � 1, effective July 1. L. 2018: (1), (2)(a)(I)(B), (3)(b), and (4)(a) repealed, IP(2)(a)(I), (2)(a)(I)(A), (2)(a)(I)(C), (2)(a)(II), (3)(a), and (5) amended, and (7) to (11) added, (HB 18-1006), ch. 368, p. 2217, � 6, effective July 1.