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CLEP: Limited Service Laboratories

Limited Service Laboratories 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 performing only waived and/or provider-performed microscopy procedures (PPMP).

Limited Service Laboratory Registration Application Materials

Facilities must first register with the Clinical Laboratory Evaluation Program by completing a Limited Service Laboratory Registration Application.
Initial Registration Application Instructions DOH-4081i PDF HTM
Initial Registration Application DOH-4081 PDF
Multi-Site Registration Application Instructions DOH-4081MSi PDF HTM
Multi-Site Registration Application DOH-4081MS PDF

Limited Service Laboratory Registration Change Forms

To document changes in laboratory status, or to add or delete tests, use the change forms below.
Notification of Change in Laboratory Director DOH-4236b PDF
Notification of Change in Laboratory Owner Information DOH-4236c PDF
Notification of Change in Laboratory Location DOH-4236d PDF
Notification to Add/Delete Test(s) DOH-4236e PDF
Notification of Change in Laboratory Name DOH-4236f PDF

Reference Material

Public Health Law Pertaining to Limited Service Laboratories PDF    
Standard Practices in Laboratory Medicine for Limited Service Laboratories
Revised 11/1/13
Blood Lead Screening Standards of Practice (for Waived Testing Devices) PDF    
LeadCare II Device Q&A   HTM
Contact Us   HTM

Mailing Instructions

Mail the form with original signatures to:

New York State Department of Health
Wadsworth Center
Clinical Laboratory Evaluation Program
PO Box 509
Albany, NY 12201-0509

Questions should be directed to the Clinical Laboratory Evaluation Program by telephone at (518) 402-4253, or by email: