Title of Regulation: 12VAC5-120. Regulations for Testing Children for Elevated Blood-Lead Levels (amending 12VAC5-120-10, 12VAC5-120-30; adding 12VAC5-120-35).

Statutory Authority: § 32.1-46.1 of the Code of Virginia.

Effective Date: December 31, 2009.

Agency Contact: Nancy Van Voorhis, Director, Lead Safe Virginia, Department of Health, 109 Governor St., Richmond, VA 23219, telephone (804) 864-7694, or email nancy.vanvoorhis@vdh.virginia.gov.

Summary:

The amendments permit the use of the Clinical Laboratory Improvement Amendments (CLIA)-waived instruments for point-of-care testing to screen for elevated blood-lead levels, provided any elevated blood-lead level is followed up with a venous blood-lead test performed by a qualified laboratory. The amendments also require health care providers to make information available on the dangers of lead poisoning, along with a list of available resources, to parents as part of regular well-check visits for all children up to 72 months of age.

Summary of Public Comments and Agency's Response: No public comments were received by the promulgating agency.

Part I
Definitions and General Information

12VAC5-120-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Board" means the State Board of Health.

"Commissioner" means the Commissioner of Health.

"Elevated blood-lead level" for children means 10 or more micrograms of lead per deciliter of whole blood in a child up to and including 72 months of age.

"Health care provider" means a physician or his designee or an official of a local health department.

"High-risk zip code ZIP Code area" means a zip code ZIP Code area listed in guidelines issued by the Virginia Department of Health in which 27% or more of the housing was built before 1950 or 12% or more of the children have elevated blood-lead levels based on current available data.

"Physician" means a person licensed to practice medicine in any of the 50 states or the District of Columbia.

"Point of care testing" refers to testing by a health care provider that has a CLIA Certificate of Waiver.

"Qualified laboratory" means a laboratory that is certified by the Health Care Financing Administration in accordance with the Clinical Laboratory Improvement Act (42 CFR Part 430) Amendments of 1988 (CLIA) (42 CFR Part 493) and is participating in the Centers for Disease Control and Prevention's (CDC) Blood Lead Laboratory Proficiency Program.

"μg/dL" means micrograms of lead per deciliter of whole blood.

Part II
Protocol for Identification of Children with Elevated Blood-Lead Levels

12VAC5-120-30. Schedule for testing.

Virginia health care providers should test all children up to and including 72 months of age for elevated blood-lead levels according to the following schedule unless they are determined under 12VAC5-120-60 to be at low risk for elevated blood-lead levels. All blood-lead samples shall be analyzed by a qualified laboratory. The use of a CDC-approved and CLIA-waived instrument for point-of-care testing, as a means of administering screening tests for elevated blood-lead levels, is exempted from the requirement to have all blood-lead samples analyzed by a qualified laboratory. However, any elevated blood-lead level found through point-of-care testing to be equal to or greater than 10 μg/dL shall be confirmed by a venous blood-lead test performed by a qualified laboratory in accordance with the requirements of 12VAC5-120-40.

1. Children should be tested at ages one and two years.

2. Children from 36 through 72 months of age should be tested if they have never been tested.

3. Additional testing may be ordered by the health care provider.

4. Children should be tested at the request of a parent or guardian due to any suspected exposure.

12VAC5-120-35. Information about lead poisoning.

The health care provider shall make available to parents information on the dangers of lead poisoning, along with a list of available resources, as part of regular well-check visits for all children up to 72 months of age.