Colorado § 25-4-1004 - Newborn screening - rules.

§ 25-4-1004. Newborn screening - rules.

(1) (a) Repealed.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.