Part IX
Protocol for Identification of Children with Elevated Blood Lead Levels

12VAC5-90-215. Schedule and criteria for and confirmation of blood lead testing and information to be provided.

A. Schedule for testing. Every child shall be tested to determine the blood lead level at 12 months and 24 months of age if the health care provider determines that the child meets any of the criteria listed in subsection B of this section. Children 25 months through 72 months of age who present for medical care and meet any of criteria of subsection B of this section shall also be tested if they have either not previously been tested for blood lead level or were previously tested but experienced a change since testing that has resulted in an increased risk of lead exposure based on the criteria listed in subsection B of this section.

B. Criteria for testing.

1. The child is eligible for or receiving benefits from Medicaid or the Special Supplemental Nutrition Program for Women, Infants and Children (WIC);

2. The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1960;

3. The child is living in or regularly visiting a house, apartment, dwelling, structure, or child care facility built before 1978 that has (i) peeling or chipping paint or (ii) recent (within the last six months) ongoing or planned renovations;

4. The child is living in or regularly visiting a house, apartment, dwelling, or other structure in which one or more persons have blood lead testing yielding evidence of lead exposure;

5. The child is living with an adult whose job, hobby, or other activity involves exposure to lead;

6. The child is living near an active lead smelter, battery recycling plant, or other industry likely to release lead;

7. The child's parent, guardian, or other person standing in loco parentis requests the child's blood be tested due to any suspected exposure; or

8. The child is a recent refugee or immigrant or is adopted from outside of the United States.

C. Exceptions. A child who does not meet any of the schedule or criteria provided in subsection A or B of this section is considered to be at low risk, and testing is not required but may be conducted at the discretion of the health care provider. The testing requirement shall be waived if the parent, guardian, or other person standing in loco parentis of a child objects to the testing on the basis that the procedure conflicts with his religious tenets or practices.

D. Confirmation of blood lead levels. Blood lead level testing shall be performed on venous or capillary blood. Tests of venous blood performed by a laboratory certified by the federal Centers for Medicare  & Medicaid Services in accordance with 42 USC § 263a, the Clinical Laboratory Improvement Amendment of 1988 (CLIA-certified), are considered confirmatory. Tests of venous blood performed by any other laboratory and tests of capillary blood shall be confirmed by a repeat blood test, preferably venous, performed by a CLIA-certified laboratory. Such confirmatory testing shall be performed in accordance with the following schedule:

1. Within one to three months if the result of the capillary test is at or above the CDC's reference value and up to 9 micrograms of lead per deciliter of whole blood (µg/dL).

2. Within one week to one month if the result of the capillary test is 10-44 µg/dL. The higher this test result, the more urgent the need for a confirmatory test.

3. Within 48 hours if the result of the capillary test is 45-59 µg/dL.

4. Within 24 hours if the result of the capillary test is 60-69 µg/dL.

5. Immediately as an emergency laboratory test if the result of the capillary test is 70 µg/dL or higher.

E. Information to be provided. As part of regular well-check visits for all children, the health care provider shall make available to parents, guardians, or other persons standing in loco parentis information on the dangers of lead poisoning, potential sources of lead and ways to prevent exposure, and a list of available lead-related resources. When blood lead level testing is performed, the health care provider shall share the child's blood lead level test result with the child's parent, guardian, or other person standing in loco parentis and report to the local health department in accordance with the requirements of 12VAC5-90-80.

CHAPTER 120
REGULATIONS FOR TESTING CHILDREN FOR ELEVATED BLOOD-LEAD LEVELS (REPEALED)

Part I
Definitions and General Information

12VAC5-120-10. Definitions. (Repealed.)

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 area" means a 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 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.

12VAC5-120-20. Statement of general policy. (Repealed.)

The Commonwealth of Virginia has recognized the need for early identification of children with elevated blood-lead levels to alert parents and guardians to the need for intervention to prevent physical, developmental, behavioral, and learning problems associated with elevated blood-lead levels in children, and to prevent exposure of other children.

The purpose of this chapter is to provide a protocol for identifying children with elevated blood-lead levels.

The department encourages health care providers, parents and guardians to exercise reasonable, but liberal judgment and discretion in implementing and applying the protocol set forth in this chapter, so that the health of all Virginia's children may be protected from lead poisoning.

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

12VAC5-120-30. Schedule for testing. (Repealed.)

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. (Repealed.)

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.

12VAC5-120-40. Confirmation of blood-lead levels. (Repealed.)

Testing may be performed on venous or capillary blood collected in tubes or on filter paper. If a test of capillary blood reveals an elevated blood-lead level, the results shall be confirmed by a repeat blood test (preferably venous):

1. Within three months if the result of the capillary test is 10 μg/dL to 19 μg/dL.

2. Within one week to one month if the result of the capillary test is 20 μg/dL to 44 μg/dL. The higher this test result, the more urgent the need for a confirmation test.

3. Within 48 hours if the result of the capillary test is 45 μg/dL to 59 μg/dL.

4. Within 24 hours if the result of the capillary test is 60 μg/dL to 69 μg/dL.

5. Immediately as an emergency laboratory test if the result of the capillary test is 70 μg/dL or higher.

Elevated blood lead results from venous blood testing shall be deemed a confirmed test.

12VAC5-120-50. Risk factors requiring testing. (Repealed.)

A health care provider shall test any child for elevated blood-lead level, or have such a child tested, if the provider determines, in the exercise of medical discretion, that such testing is warranted, and that the child meets one or more of the following criteria:

1. Eligible for or receiving benefits from Medicaid or the Special Supplemental Nutrition Program for Women, Infants and Children (WIC);

2. Living in a high-risk zip code area;

3. Living in or regularly visiting a house or child care facility built before 1950;

4. Living in or regularly visiting a house, apartment, dwelling or other structure, or a child care facility built before 1978, with peeling or chipping paint or with recent (within the last six months), ongoing, or planned renovations;

5. Living in or regularly visiting a house, apartment, dwelling or other structure in which one or more persons have elevated blood-lead levels;

6. Living with an adult whose job or hobby involves exposure to lead as described in Preventing Lead Poisoning in Young Children (CDC, 1991);

7. Living near an active lead smelter, battery recycling plant, or other industry likely to release lead;

8. The child's parent or guardian requests the child's blood be tested due to any suspected exposure; or

9. A health care provider recommends the child's blood be tested due to any suspected exposure.

The Department of Health will maintain a list of high-risk zip code areas in Virginia.

12VAC5-120-60. Determination of low risk for elevated blood-lead levels. (Repealed.)

Blood-lead testing is not indicated for children determined by a health care provider to be at low risk for elevated blood-lead levels. A health care provider may determine a child to be at low risk for elevated blood-lead level if the child meets none of the criteria listed in 12VAC5-120-50, but is encouraged to cause a child to be tested if, in the exercise of discretion and consideration of the various means by which exposure to lead may occur, such exposure cannot be clearly ruled out.

12VAC5-120-70. Samples submitted to a qualified laboratory. (Repealed.)

A. All blood samples submitted to a qualified laboratory for analysis shall be accompanied by a completed laboratory requisition with all of the required data as determined by the Department of Health.

B. All qualified laboratories accepting blood samples for lead analysis under this chapter shall submit all required data to the board within 10 business days of analysis. The data shall be sent by a secure electronic means that has been approved by the Department of Health.

C. Any laboratory reporting under this section shall be deemed in compliance with the stipulations of § 32.1-36 of the Code of Virginia and 12VAC5-90-90 of the Board of Health Regulations for Disease Reporting and Control.

12VAC5-120-80. Follow-up testing and information. (Repealed.)

The Department of Health will establish guidelines for follow-up testing for children with confirmed elevated blood-lead levels, provide or recommend appropriate information for parents, and disseminate through various available means the protocol and other information to all relevant health care professionals. The department encourages health care professionals to conduct whatever follow-up testing is indicated or warranted in the exercise of medical or clinical judgment and discretion.

12VAC5-120-90. Exclusion from testing when risk is low and on religious grounds. (Repealed.)

In accordance with § 32.1-46.2 of the Code of Virginia, every child in the Commonwealth should be tested for elevated blood-lead levels or determined to be at low risk for elevated blood-lead levels unless the parent, guardian or other person standing in loco parentis obtains a determination that the child is at low risk for elevated blood-lead levels or unless the parent, guardian or other person having control or charge of such child objects to such testing on the basis that the procedure conflicts with his religious tenets or practices.