Physician Office Laboratory Evaluation
Program (POLEP)
Application Materials
-
Application for Clinical Laboratory ImprovementAmendments (CLIA) certification and instructions ( CMS –116)
(PDF file) - Laboratory Director Requirements
Mail or fax completed applications to:
Physician Office Laboratory Evaluation Program
New York State Department of Health
Wadsworth Center
P.O. Box 509
Albany, NY 12201-0509
Fax: (518) 485-5355
Changes to Physician Office Laboratory Information
A new form CMS-116 must be submitted to POLEP when any of the following laboratory changes take place:
- Recertification Survey
- All Certificates Changes other than downgrading to a Certificate of Waiver
- Reinstatement of CLIA certificate
- Director Change - Certificate of Provider Performed Microscopy or Compliance
Written notification on Practice Letterhead may be submitted to POLEP when any of the following changes occur:
- Ownership
- Status Change downgrading to Certificate of Waiver
- Name of Laboratory
- Location (Physical Location)
- Mailing Address
- Tax ID (EIN)
- Specialty Change
- Total Volume Change
- Telephone and Fax Numbers
- Reinstatement
- Change in Accreditation Organization
- Voluntary Closure/Termination
- Personnel-Technical Supervisor
- Director Change - Certificate of Waiver
Written notification includes an email, fax or hard copy letter. The written notification must include laboratory name, CLIA number, name of Laboratory Director and the change(s) being made, and the signature of the Laboratory Director. In lieu of written notification, a new CMS-116 form is also acceptable. Please note the CMS-116 must be completed in its entirety.
Mail or fax changes to:
Physician Office Laboratory Evaluation Program
New York State Department of Health
Wadsworth Center
P.O. Box 509
Albany, NY 12201-0509
Fax: (518) 485-5355