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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).

1 Register as a Limited Laboratory or, if you are already registered, add the LeadCare II test to your tests menu

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) in order to obtain a federal CLIA number and authorization to perform patient testing. These include hospital extension clinics, nursing homes, home health care agencies, school/student health services, dialysis facilities, ambulatory surgery centers, county health departments, correctional facilities, ambulance/rescue squads, and other direct patient care facilities. Physician offices performing only waived or PPMP tests that are owned and/or operated by managed care organizations, hospitals or consulting firms are also included in this group. Not-for-profit, state or local government laboratories or programs engaged in limited public health testing not exceeding fifteen types of test per registration may be eligible to apply for a multi-site CLIA number.

• Download registration application instructions
• Download registration application form
• Download change form to add LeadCare II to your menu of waived tests

• On the question: WAIVED TEST PROCEDURES REQUESTED (8a on the initial application) - indicate LeadCare II Blood-Lead Testing System

To fulfill the requirements of Section 8A:

• Print pages 5-7 of the following document and maintain for your records. (http://www.accessdata.fda.gov/cdrh_docs/pdf5/K052549.pdf)
• Create a written protocol for lead testing in accordance with manufacturer's instructions: refer to the manufacturer's package insert (located in each test kit) and the Blood Lead Practice Standards (http://www.wadsworth.org/labcert/clep/Administrative/lab-standards-lead-testing-wd.pdf)
• The application fee is $200. Your check or money order should be made payable to the New York State Department of Health. The check or check stub should indicate the laboratory's name.
• Mail completed applications with your check or money order to:
  New York State Department of Health
  Wadsworth Center
  Clinical Laboratory Evaluation Program
  P.O. Box 509
  Albany, NY 12201-0509

More details

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

To request details on the LeadCare II
test: Doctors click here
Public health click here