Provider Approval for In-Office Blood Lead Testing

• About In-Office Blood Lead Testing
• Approval Criteria
• How to Apply for Approval
• Applications for a Practice with Multiple Locations
• Application Review
• Questions?
• Data Reporting Requirements for In-Office Blood Lead Testing

About In-Office Blood Lead Testing

• As of November 5, 2012, Maine law allows approved providers to perform in-office blood lead testing of children under age 6 years using a direct-read blood lead analyzer and to electronically report test results to the Maine Childhood Lead Poisoning Prevention Unit. (Read the rules related to the law .)
• The intent of the law is to increase blood lead testing of children under age 6 years.
• Currently, the only CLIA-waived, in-office, direct-read blood lead testing device is the LeadCare II , made by Magellan Diagnostics.
• Providers must have approval from the Maine Childhood Lead Poisoning Prevention Unit before they can begin in-office testing. The purpose of the approval is to ensure 1) that in-office blood lead testing will remove barriers to testing; and, 2) that providers using in-office testing will be able to have complete, timely, and electronic reporting of results directly to Maine Childhood Lead Poisoning Prevention Unit.

Approval Criteria

Before beginning in-office blood lead testing, providers must be approved by the Maine Childhood Lead Poisoning Prevention Unit. Approval criteria include:

1. proof of current use of ImmPact2 Immunization Registry;
2. written protocols for testing a patient's blood lead and reporting results to the patient's parent/guardian within the same office visit and the reporting of test results to the Maine Childhood Lead Poisoning Prevention Unit;
3. CLIA Certificate of Waiver.

How to Apply for Approval

To apply for approval, submit an application by mail or email to:

Sandra Dempsey
Nurse Education Consultant, Childhood Lead Poisoning Prevention Unit
Maine CDC/DHHS
286 Water Street, 9th Floor
State House Station 11
Augusta, ME 04333
sandra.dempsey@maine.gov

Applications must include the following.

1. A cover letter including the name, practice name, mailing address, and phone number for all communication regarding your application.

2. Proof of current use of ImmPact2 Immunization Registry. Please provide a copy of your ImmPact User Agreement.

3. A brief description of your protocols for in-office testing and data reporting. Descriptions may be narrative and/or represented in a diagram or flow chart and must clearly demonstrate the following.

• How you will use in-office testing to analyze a patient's blood sample during an office visit and how you will report blood lead results to the parent/guardian during that same office visit.
• How test results will be recorded from the device and submitted to the Maine Childhood Lead Poisoning Prevention Unit with the required data elements.

4. A copy of your CLIA Certificate of Waiver. Find out how to apply for a CLIA Certificate of Waiver It can take about two to four weeks to get a certificate. For questions about CLIA certification, contact: Dale Payne, CLIA Laboratory Certification Supervisor, 207-287-9339, dale.payne@maine.gov or read more about CLIA Certificates of Waiver .

Applications from Practices with Multiple Locations

• Providers seeking approval for in-office blood lead testing at multiple locations of their practice should submit separate applications for each site unless protocols for testing and reporting are identical at each site and the practice has a CLIA Certificate of Waiver for each site.
• If protocols are identical, a practice with multiple locations may submit a single application that includes all of the requirements above and the address of each practice location seeking approval in the cover letter and copies of the CLIA Certificate of Waiver for each location.

Application Review

Maine Childhood Lead Poisoning Prevention Unit staff will review and approve or deny applications within one week of receipt. Providers will receive a letter documenting approval from the Maine Childhood Lead Poisoning Prevention Unit.

If applications are denied, the Maine Childhood Lead Poisoning Prevention Unit will report reasons to the applicant. Applicants may address reasons and re-apply for approval. Applications may be denied for the following reasons.

1. Lack of ability to draw blood and report results to patient within a single visit.
2. Lack of proof of access to ImmPact2 for the purpose of reporting blood lead results to the Maine Childhood Lead Poisoning Prevention Unit.
3. Lack of CLIA Certificate of Waiver.

In addition, Maine Childhood Lead Poisoning Prevention Unit staff will review approved providers every two years to evaluate the effectiveness of reporting in-office blood lead test results. If problems are identified during this evaluation, staff of the Childhood Lead Poisoning Prevention Unit will discuss the problems and possible solutions with the provider. If problems with reporting continue, approval for in-office blood lead testing will be revoked.

Questions?

Contact Sandra Dempsey, Nurse Education Consultant, Childhood Lead Poisoning Prevention Unit, 207-287-8671 or sandra.dempsey@maine.gov.