10-144 Me. Code R. ch. 292 § 5

A. General Provisions

(1) All health care providers must advise parents of the availability and advisability of screening their children for lead poisoning. A health care program that receives funds from the State of Maine and has a child health component must provide screening of children for lead poisoning, in accordance with rules adopted by the Department. The blood level screening and testing must be performed in accordance with this Section.

(2) The Department may approve facilities to perform in-office blood lead testing to reduce the barrier of blood lead testing when the patient needs to travel to an offsite location (22 M.R.S.§1319-D). The following describes the conditions under which in-office blood lead testing will be approved, including the requirements for electronic data reporting.

B. Screening by Health Care Providers

For the purposes of 22 M.R.S.§1317-C(1), except as otherwise provided by these rules, all health care providers shall advise parents of the availability and advisability of screening their children for lead poisoning. A health care program that receives funds from the State and has a child health component shall provide screening of children for lead poisoning, in accordance with these rules. Screening in this context is defined as use of the “lead poisoning risk assessment tool” as described in 22 M.R.S.§1317-D(1) and appropriate follow up should blood lead testing be appropriate.

C. Laboratory Testing: Except as hereinafter provided by these rules, a blood sample taken from a child, by a health care provider or laboratory to test for blood lead levels should be sent to the State of Maine Health and Environmental Testing Laboratory for analysis. This requirement includes all venous draw blood lead and all capillary blood lead draws.

D. In-Office Blood Lead Testing

(1) The Department may approve In-Office blood lead testing in locations where the patient can have a blood sample drawn, analyzed and receive the results of the analysis all during the same office visit.

(2) CLIA waived in-office lead analyzing devices are the only blood lead analyzers approved for this purpose. Health care providers will be responsible for purchasing their own devices and supplies and maintaining the analyzer in compliance with the manufacturers’ instructions.

(3) Electronic Reporting Requirements

(a) All in-office blood lead test results (whether elevated or not) on children prior to their sixth birthday shall be reported to the Department within 48 hours. If blood lead results are elevated or require confirmation, venous blood lead testing through the State of Maine Health and Environmental Testing Laboratory is required.

(b) In-office blood lead test results will be reported to the Department using a blood lead module through the ImmPact2 immunization registry. If ImmPact2 does not have lead reporting capability, the Department will make available either an alternate secure web based or email form or fax based form until such time as ImmPact2 has blood lead reporting capability.

(c) Approval of facilities for in-office blood lead testing

(i) Health care providers, Head Start facilities, and clinics that dispense benefits of the Women, Infants and Children Special Supplemental Food Program of the Federal Child Nutrition Act of 1966, must be approved by the Department before a CLIA-waived In-Office lead analyzing device, can be used. Approval will occur every two years on the same timeline as paying the two year CLIA Waiver certificate fee. Approval will be based on meeting the intent of the legislation which is to address barriers to blood lead testing based on a patient having to travel to an offsite location to have blood drawn. Approval will depend on:

Current use of the ImmPact2 Immunization Registry;

Submission of a short description of the protocol for a patient whose blood lead is being tested during a single visit and the reporting of that data to the Department. Head Start facilities and clinics that dispense benefits of the Women, Infants and Children Special Supplemental Food Program of the Federal Child Nutrition Act of 1966, are required to describe the protocol for electronic submission of data to both the Department and the provider.

A copy of the CLIA waiver certificate.

(ii) Denial and review

(a). If an application is denied, the Department will report the reasons for the denial and any deficiencies identified can be corrected and the facility can reapply.

(b). Reasons for denial may include:

(1). Need for the patient to leave the health care providers offices to have blood drawn and reported to the patient.

(2). Lack of access to draw blood and report results to the patient within a single visit.

(3). Lack of access to ImmPact2 for the purpose of reporting blood lead results to the Department.

(4). Lack of CLIA waiver certificate.

(5). Not reporting blood lead test results (evaluated upon 2 year review).