Print CA Summary
	CLIA Waiver & CA Registration	Reporting	Proficiency Testing	Reimbursement

The LeadCare II blood-lead test is a CLIA-waived system. All facilities that use the system to perform blood-lead tests must have a CLIA Certificate of Waiver (or a higher-level CLIA license), be registered or licensed by the state, and report electronically ALL blood-lead level results to the Childhood Lead Poisoning Prevention branch.

• Download the publication, An Overview of Requirements for Point of Service Blood Lead Testing Devices in California

1 Obtain a CLIA Certificate of Waiver

If you don't yet have a CLIA Certificate of Waiver:

• Download application instructions
• Download the application form
• Download the fee schedule

• Submit the fee, payable to California Department of Public Health ($62 in 2009), and all required documents to:

  CDPH - Laboratory Field Services
  Laboratory Facility Licensing
  850 Marina Bay Parkway, Bldg P, 1st Floor
  Richmond, CA 94804-6403

The federal CLIA program will bill you separately for the CLIA certification fee

 

If you already have a CLIA Certificate of Waiver (or higher) fax or email it to:

• Attn: Mario Amanzio
  CDPH - Childhood Lead Poisoning Prevention Branch
  850 Marina Bay Parkway, Bldg P, 3rd Floor
  Richmond, CA 94804-6403
  e-mail: EBLRSupport@cdph.ca.gov
  fax: 510.620.5702

2.Register with the State of California, Laboratory Field Services

 

• Complete form: LAB 155

• Download LAB 155 form

• Submit the complete form and registration fee payable to California Department of Public Health ($62 in 2009), to:
  CDPH - Laboratory Field Services
  Laboratory Facility Licensing
  850 Marina Bay Parkway, Bldg P, 1st Floor
  Richmond, CA 94804-6403

To purchase a LeadCare II system, call (800) 305.0197