16 Del. Admin. Code § 4459A-7.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4459A-7.0 - Blood Lead Level Screening and Testing Documentation and Reporting Requirements

7.1 All laboratories and health-care providers involved in blood lead level analysis, including screening and testing, shall participate in a universal reporting system as established by the Division of Public Health.

7.2 The laboratory, health care provider's office, or other facility that administers a blood lead level screening or test for a child younger than 18 years old shall obtain the information required by this regulation at the time of drawing the blood specimen.

7.3 A laboratory that performs blood lead analysis shall provide a referral form of paper or electronic requisition that specifies the required information for use by a laboratory, a health care provider's office, or another facility that draws a blood specimen. The facility that draws a blood specimen shall:

7.3.1 Record the information required under this regulation on the laboratory's referral form or similar form; and

7.3.2 Forward the required information concurrently with the blood specimen to the laboratory that performs blood lead analysis.

7.4 A laboratory required to report a blood lead level screening or test under this regulation shall report the blood lead level screening or test in the format approved by the Division and shall include the following information:

7.4.1 The child's demographic information, including:

7.4.1.1 First name, middle initial, and last name;

7.4.1.2 Date of birth;

7.4.1.3 Country of birth;

7.4.1.4 Sex;

7.4.1.5 Race and ethnicity;

7.4.1.6 Master Client Index (MCI) number if the child is enrolled in Medicaid or a Delaware children's health program;

7.4.1.7 Complete home address at the time the blood specimen was drawn, including house or apartment number, street, city or town, county, zip code, and state;

7.4.1.8 Telephone number; and

7.4.1.9 Parent's or guardian's name.

7.4.2 Type of blood specimen, venous or capillary, and the blood draw date;

7.4.3 The health care provider's name, office name, address, telephone number, and national provider identifier (NPI);

7.4.4 If the draw site is different from the health care provider's office, the laboratory's or other facility's name, address, telephone number, and NPI;

7.4.5 All of the following information about the laboratory performing the blood lead analysis:

7.4.5.1 Laboratory name, address, telephone number, and clinical laboratory improvement amendment number (CLIA);

7.4.5.2 Laboratory method used to analyze the blood specimen;

7.4.5.3 The limit of detection for the method used to analyze the blood specimen; and

7.4.5.4 If reporting a "no result" screening or test result, the limit of detection for the laboratory method.

7.4.6 Blood lead level in micrograms per deciliter expressed with a numeric results comparator of:

7.4.6.1 Equal, if the blood lead level is an exact measurement; or

7.4.6.2 Less than or greater than, if a blood lead level reading is below or above a certain level that a device used to analyze a blood specimen can accurately record.

7.4.7 Additional information as may be required by the Division.

16 Del. Admin. Code § 4459A-7.0

27 DE Reg. 109 (8/1/2023) (Final)