ORDER OF
DEPARTMENT OF HEALTH SERVICES
TO ADOPT PERMANENT RULES
The Wisconsin Department of Health Services proposes an order to renumber and amend DHS 115.04 (1), (2), and (3) and 115.05 (3); to amend 115.01, 115.02, and 115.04 (intro.), (2), (3), (5) to (7), (9) to (14), and as created by this rule (16); to repeal and recreate 115.03 (3) and 115.04 (4), (8), and as created by this rule (15); and to create 115.04 (1) (b), (15) and (16), relating to screening newborns for congenital and metabolic disorders.
RULE SUMMARY
Statute interpreted
Statutory authority
Explanation of agency authority
Section 227.11 (2) (a) reads: Rule-making authority is expressly conferred on an agency as follows: (a) Each agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation. All of the following apply to the promulgation of a rule interpreting the provisions of a statute enforced or administered by an agency:
1. A statutory or nonstatutory provision containing a statement or declaration of legislative intent, purpose, findings, or policy does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
2. A statutory provision describing the agency's general powers or duties does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
3. A statutory provision containing a specific standard, requirement, or threshold does not confer on the agency the authority to promulgate, enforce, or administer a rule that contains a standard, requirement, or threshold that is more restrictive than the standard, requirement, or threshold contained in the statutory provision.
Section 253.13 (1): (1) Tests; requirements. The attending physician or nurse licensed under s. 441.15 shall cause every infant born in each hospital or maternity home, prior to its discharge therefrom, to be subjected to tests for congenital and metabolic disorders, as specified in rules promulgated by the department. If the infant is born elsewhere than in a hospital or maternity home, the attending physician, nurse licensed under s. 441.15, or birth attendant who attended the birth shall cause the infant, within one week of birth, to be subjected to these tests. Related statute or rule
See the “Statute interpreted” section.
Plain language analysis
As provided in s. 253.13 (1), Stats. (2011-12), ch. DHS 115 specifies the congenital and metabolic orders for which newborns must be screened by means of a blood sample shortly after birth and tested by the Wisconsin State Laboratory of Hygiene (WSLH). 2013 Wisconsin Act 135 modified s. 253.13 (1) Stats., relating to infant blood tests to provide that the required screening may be performed by methods in addition to blood testing. Under the proposed rules the department revises ch. DHS 115 to conform the rules to s. 253.13 (1), Stats. The proposed rules add critical congenital heart disease (CCHD) and organic acidemias (OA) as conditions for which newborns must be tested. CCHD is usually described as those congenital cardiac malformations in which surgical or catheter-based therapy is necessary within the first months of life, and is screened for by use of pulse oximetry. In September 2010, the U.S. Department of Health and Human Services, Discretionary Advisory Committee on Heritable Disorders in Newborns and Children added CCHD to its Recommended Uniform Screening Panel Core Conditions. To date, 35 states have added CCHD screening to their newborn screening panel.
OA is a group of inherited disorders that lead to an abnormal buildup of particular acids known as organic acids in the body for which the WSLH currently tests newborns. Though the criteria under s. DHS 115.06 were met for OA to be added to the list of congenital and metabolic disorders for which WSLH must test blood samples, the disorders were inadvertently omitted from subsequent revisions of s. DHS 115.04. The department promulgated emergency rules effective July 3, 2014, to add CCHD and OA to the list of conditions for which newborns must be screened.
Currently, the conditions listed in s. DHS 115.04, are coded using the International Classification of Diseases, 9th Revision (ICD-9 CM). The U.S. Department of Health and Human Services requires health care providers, health plans, and health care clearinghouses to transition to the International Classification of Diseases, 10th Revision (ICD-10 CM) effective October 1, 2015. To ensure consistency among health care providers and to facilitate the transition in this order, the proposed rule lists the ICD-10 CM codes for the CCHD and OA conditions proposed, and the conditions already listed in s. DHS 115.04. The transition to the ICD-10 CM codes in the proposed rule will occur on October 1, 2015. Summary of, and comparison with, existing or proposed federal regulations
There appears to be no existing or proposed federal regulations that address the activities to be regulated by the proposed rules.
Comparison with rules in adjacent states
Illinois, Iowa, Michigan, and Minnesota state law require that newborns be screened for congenital and metabolic disorders, including CCHD and organic acidemias.
Illinois:
Illinois does not list in administrative rules, the congenital or metabolic disorders for which infants are screened.
Iowa:
Iowa does not list in administrative rules, the congenital or inherited disorders for which infants are screened.
Michigan:
Michigan does not list in administrative rules, the congenital or metabolic disorders for which infants are screened.
Minnesota:
Minnesota does not list in administrative rules, the congenital or metabolic disorders for which infants are screened.
