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	CLIA Waiver	Practice Standards	Reporting	Reimbursement

All other facilities that offer laboratory testing, holding a permit issued by the NYSDOH Clinical Laboratory Evaluation Program (CLEP) in the category of Toxicology -Blood Lead.

2 Follow practice standards

Laboratories were notified of a change in practice standards for blood lead reporting by letter issued in June 2009. (See link below.) Effective September 1, 2009, reference ranges on laboratory-generated patient reports must indicate that blood lead levels 5-9 μg/dL have been associated with adverse health effects in children 6 years and younger. Reports should not indicate that blood lead levels less than 10 micrograms/dL are "Normal." This commentary language has been designated as Blood Lead Standard 11 (BL 11), and it will be required of all laboratories holding a New York State permit in the category Toxicology-Blood Lead.

Blood lead test results greater than or equal to 8 micrograms per deciliter (μg/dL) generated by LeadCare II system must be confirmed with an appropriately collected venous sample, analyzed by a clinical laboratory that holds a NYS permit in toxicology-blood lead using another test method. The level of 8 μg/dL has been established by the NYSDOH to maximize the identification of children with lead poisoning.

• If the blood-lead level is > 8 μg/dL, send a venous sample to a NYS DOH laboratory permitted for blood lead confirmation testing, or refer the patient to that laboratory's patient service center for collection of a venous blood sample.
• Record the results with a comment stating: "results of confirmatory testing are pending."

Note: This threshold has been set for point-of-care testing using waived test methods, such as the LeadCare® II system. The NYSDOH has established a confirmation threshold level > 10 μg/dL for non-waived methods

• Read the letter to laboratory directors
• Download practice standards here

Quality control

• You must run two levels of quality control (included with all LeadCare II Test Kits) according to the manufacturer's instructions, which are:

• Each new lot.
• Each new shipment of materials even if it's the same lot previously received.
• Each new operator (i.e. operator who has not performed the test recently).
• Monthly, as a check on continued storage conditions.
• When problems (storage, operator, instrument, or other) are suspected or identified.
• If otherwise required by your laboratory's standard QC procedures.

Critically elevated blood-lead levels

• If a child's (under age 18) blood-lead level is > 45 μg/dL, you must notify the local health department within 24 hours of analysis or notification by the laboratory.

Please refer to the Reporting tab for details on all the reporting requirements.

Note: If the patient, regardless of age, resides in New York City, current New York City Health Code reporting requirements take effect.

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