Blood Lead Testing Information for Clinical Laboratories and Physician Office Laboratories

This page is intended for health care providers and clinical laboratories that analyze specimens and report blood lead test results. This page contains links to the rules and regulations governing laboratory certification in New York State (NYS), including federal certification of physician office labs located in NYS. It also contains links to regulations and standards covering the administration, analytical procedures, and reporting of blood lead test results, as well as contact information.

All laboratories conducting blood lead testing, including those located within clinics and physician offices, must be certified, registered, and/or permitted by DOH's Wadsworth Center. In addition, all blood lead test results must be reported to DOH in accordance with NYS Public Health Law and regulations. Changes to law and regulations went into effect June 20, 2009. If you are conducting blood lead testing, please become familiar with current law and regulations, described in detail on the following links. If you have additional questions after reading these documents, feel free to call or email for more information using the contact information below.

Physician Office Labs and Limited Service Laboratory Registrants approved for blood lead testing using a CLIA-waived point-of-care testing device are required by law to comply with manufacturer's instructions and practice standards for such testing.

Information regarding testing and reporting requirements for each type of laboratory is summarized below.

Physician Office Laboratory Evaluation Program

Certification

Individual practitioners or group private practices that conduct in-house laboratory testing on their own patients must be certified by the federal Centers for Medicare and Medicaid Services (CMS) through the NYSDOH's Physician Office Laboratory Evaluation Program (POLEP). For additional information call (518) 485-5352, write to CLIA@health.state.ny.us or visit Physician Office Laboratory Evaluation Program.

Reporting

Physician office labs that conduct lead testing must report all results to the NYS Department of Health (DOH) or, in New York City, to the NYC Department of Health and Mental Hygiene. For additional information on reporting, please contact the NYSDOH Lead Poisoning Prevention Program 518-402-5706 or write to LPPP@health.state.ny.us.

Limited Service Laboratories

Registration

Facilities that are not private practices (e.g., off-site clinics) that conduct point-of-care testing using only CLIA-waived procedures (with or without provider-performed microscopy) must be registered as Limited Service Laboratories with the NYSDOH Clinical Laboratory Evaluation Program (CLEP). Registration forms for Limited Service Laboratories are available at: www.wadsworth.org/labcert/clep/Administrative/ChangeForms.htm. For additional information, call 518-485-5378, or write to CLEPLTD@health.state.ny.us.

Reporting

Limited Service Laboratories that conduct lead testing must report all results to NYS DOH. For additional information on reporting, please contact the NYSDOH Lead Poisoning Prevention Program at 518-402-5706 or the Electronic Clinical Laboratory Reporting System (ECLRS) Helpdesk at 866-325-7743.

Clinical Laboratory Evaluation Program (CLEP)

Permits

All other facilities that offer laboratory testing must hold a permit issued by the NYSDOH Clinical Laboratory Evaluation Program (CLEP) in the category of Toxicology – Blood Lead. For additional information, call 518-485-5378, write to CLEP@health.state.ny.us , or visit www.wadsworth.org/CLEP.

Standards applicable to laboratories holding a NYS permit clinical laboratory permit in Toxicology - Blood Lead are available here.

Reporting

Permitted clinical laboratories must report all blood lead test results electronically using DOH's Electronic Clinical Laboratory Reporting System (ECLRS). For additional information on reporting via ECLRS, please call 866-325-7743.

Technical Questions and Resources for Blood Lead Testing

For all technical questions relating to analytical procedures, proficiency testing, and laboratory standards for blood lead testing, contact Wadsworth Center's Laboratory of Inorganic and Nuclear Chemistry at 518-474-7161, or visit: www.wadsworth.org/testing/lead/index.htm.

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