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	CLIA Waiver	Practice Standards	Reporting	Reimbursement

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).

2 Limited Laboratories are required by law to follow the "NYSDOH Blood Lead Screening Standards of Practice for WAIVED Testing Devices (e.g., Lead Care® II)"

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 LeadCareJ II system. The NYSDOH has established a confirmation threshold level > 10 μg/dL for non-waived methods.

• The practice standards require facilities to compile a procedures manual that minimally includes written policies to: ensure compliance with manufacturer's requirements for quality control; report results as applicable to your provider type; and assess personnel competency. Competency reviews of testing personnel should consider collection technique as well as performance of quality control and proficiency testing. Refer to the manufacturer's package insert (located in each test kit) and the Blood Lead Practice Standards

• 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