WISCONSIN DEPARTMENT OF HEALTH SERVICES
PROPOSED ORDER TO ADOPT RULES
The Wisconsin Department of Health Services proposes an order to repeal DHS 181.03 (11) to (13), DHS 181.04 (3) (b) and (c), DHS 181.04 (6), (7) and (Note), DHS 181.06 (1) (j) and (k), DHS 181.06 (3); to renumber and amend DHS 181.04 (3) (a); to amend DHS 181.02, DHS 181.03 (10), DHS 181.04 (5), DHS 181.06 (1) (c) to (f) and (h) and (i), DHS 181.06 (1) (L) and (n), DHS 181.06 (2), DHS 181.07 and (Note), DHS 181.08 (2) (a); and to repeal and recreate DHS 181.04 (2), DHS 181.04 (4), and DHS 181.05, relating to reporting of blood lead test results.
Explanation of agency authority
The Department’s authority to promulgate the proposed rules is provided in statute. Section 227.11 (2) (a), Stats., authorizes the Department to 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. Section 254.15, Stats., requires the Department to administer a comprehensive statewide lead poisoning prevention program that includes childhood lead poisoning screening requirements. Section 254.13, Stats., requires that the Department promulgate rules specifying the form of the required reports. Section 254.156, Stats., requires the Department to promulgate a rule defining lead poisoning or lead exposure that corresponds to the specification of the centers for disease control and prevention.
Related statute or rule
Plain language analysis
The Department proposes to amend ch. DHS 181 in order to comply with statutes governing Wisconsin’s lead poisoning prevention program. Specific revisions include: updating the blood lead reference value, updating forfeiture amounts, and updating and clarifying reporting requirements to reflect current definitions, standards and best practices.
The Department proposes to make the following revisions to the rule chapter:
1. In 2012, the U.S. Centers for Disease Control and Prevention (CDC) lowered the blood lead level at which it considers a child to be lead poisoned. The CDC now requires public health interventions at 5 µg/dL, rather than 10 µg/dL. In Wisconsin, “lead poisoning or lead exposure” is currently defined in s. DHS 181.03, as a concentration of lead in the blood of 10 µg/dL or more. Section 254.156, Stats., requires the Department to promulgate a rule defining “lead poisoning or lead exposure” to correspond to the specification of the CDC. The Department therefore proposes to update the current definition of “lead poisoning or lead exposure” to the blood lead level set by the CDC. 2. Section DHS 181.08 sets the maximum forfeiture penalty for violating provisions of the chapter to $1,000 per violation per day. This amount was based on s. 254.30 (2) (a), Stats. In 2015, Wisconsin Act 55, Section 4049d, amended s. 254.30 (2) (a), Stats., and increased the maximum forfeiture penalty to $5,000 per violation per day in compliance with the federal requirements. The proposed rule updates the current maximum forfeiture penalty, as provided in the statute. 3. Chapter DHS 181 has not been substantially revised since 2002. The Department proposes to make non-substantive corrections and clarifications to reflect current definitions, standards and best practices. There are no reasonable alternatives to the proposed rulemaking. The Department must amend ch. DHS 181 in order to comply with statutory directives provided by the Legislature.
Summary of, and comparison with, existing or proposed federal regulations
In 2012, the CDC began using a reference value of 5 µg/dL to identify children with blood lead levels that are much higher than most children’s levels.
Comparison with rules in adjacent states
Permissible blood lead levels are confirmed (venous) under 10 mcg/dL for children under age 16 years and for pregnant or breast-feeding women, and confirmed (venous) less than 25 mcg/dl for all other persons. Health care providers must report a blood lead level in excess of permissible levels to the department of health within 48 hours. All capillary results of 10 mcg/dL or more for a person under age 16 years must be reported within 48 hours. All negative results must be reported within 30 days. A Medicaid ID number must be included, if applicable. Laboratory name or laboratory code number must be reported but the rule does not specify that the clinical laboratory improvement amendments (CLIA) number is required. Date of sample analysis, occupation, and employer information are not required to be reported. Written or electronic reports are acceptable but the code also states that reports shall be on the form provided in an appendix to the administrative rule. DPH 77 Ill. Adm. Code 845
Blood lead reporting is included with other reportable poisonings and non-communicable conditions. Reporting responsibility is extended to school nurses, school officials, poison control centers, medical examiners, occupational nurses, hospitals, health care providers and clinical laboratories outside the state of Iowa for all reportable poisonings and conditions. Iowa requires reporting all test results for adults and children to the department of health. Test results greater than or equal to 20 mcg/dL in a child under age six or a pregnant woman must be reported immediately by telephone. All other results must be reported at least weekly in an electronic format. The report includes patient’s marital status and if the patient is female, whether the patient is pregnant. A report is not required to include parent/guardian name, laboratory phone number or CLIA number, date of sample analysis, occupation, or employer information. Iowa Adm. Code 641, Chapter 1.
All test results must be reported within 5 days and must include secondary contact (name, phone number) for parent/guardian if the person tested is a minor; social security number and Medicaid number, if applicable; physician/provider fax number and email address; and a specimen number. The test result must be rounded to the nearest whole number. The laboratory CLIA number is not required to be reported. Michigan requires electronic reporting by laboratories and point-of-care test sites but also allows reports to be mailed or faxed. The rule includes a quality assurance section, which allows the Department to inspect copies of the medical records pertaining to blood lead testing that will be submitted by the clinical laboratory or user of a portable blood lead analyzer to verify the accuracy of the submitted data. The rule includes a section on confidentiality of reports. The rule does not include a section on penalties and enforcement. Michigan Admin. Code R 325.9081-325.9087.
Results greater than or equal to 15 mcg/dL must be reported within 2 days, results <15 mcg/dL must be reported monthly. In comparison to ch. DHS 181, the following information is not required to be included in the report content: ethnicity, guardian name, laboratory CLIA number, employer, and occupation are not required. Method of analysis is required to be reported. Minnesota Statutes, section 144.9502.
Summary of factual data and analytical methodologies
A technical advisory committee was convened to review all content and proposed changes. The committee met on June 21, 2018 and included representatives from laboratories, local health Departments, Children’s Hospital of Wisconsin and the Department’s Division of Public Health Bureau of Environmental and Occupational Health. The committee unanimously accepted all proposed changes. The Department did not rely on data or analytical methodologies to draft the proposed rule and was instead guided by the specifications provided by the CDC.
Analysis and supporting documents used to determine effect on small business
There was a public commenting period in regards to economic impact from September 24, 2018 through October 9, 2018. No comments were received.
Effect on small business
None. The proposed rules do not impact small businesses.
Agency contact person
1 West Wilson Street
Madison, WI 53703
Statement on quality of agency data
The data sources referenced and used to draft the rules and analyses are accurate, reliable, and objective and are discussed in the “Summary of factual data and analytical methodologies.”