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Clinical Laboratory Evaluation Program - Permit Application Materials

Laboratory Director/Assistant Director Certificate of Qualification

• Application and Instructions for Certificate of Qualification (DOH-238) (PDF -- 1.8M)

Laboratory Permit Application

Download all of the following to apply for a laboratory permit. If applying for a permit in the category of cytopathology and your laboratory employs cytotechnologists that are not currently registered in New York State, you must also download and submit the cytotechnologist Initial Application (PDF -- 84K) form. If the cytotechnologist is registered in New York, you must download and submit the Change in Registration Status form. (PDF -- 84K)

• Application and Instructions for Initial Laboratory Permit Application (DOH-3494i and DOH-3494)
• Permit Category Descriptions (DOH-4022)
• Ownership and Controlling Interest Disclosure Statement Instructions DOH-3486 - (PDF -- 11K)
• Ownership and Controlling Interest Disclosure Statement DOH-3486 - (PDF -- 85K)
• Facility Personnel DOH-709 - (Fillable PDF -- 141K) | (Excel Spread Sheet -- 21K)
• Category Questionnaires
• Business Practice Guidelines (PDF -- 69K)

Changes to Laboratory Operations

• Instructions for Notification of Changes DOH-3519i - (PDF -- 9.5K)
• Notification of Change in Laboratory Name or Owner Name DOH-3519a - (PDF -- 198K)
• Notification of Change in Laboratory Director DOH-3519b - (PDF -- 222K)
• Notification of Change in Assistant Director DOH-3519c - (PDF -- 223K)
• Notification of Change in Laboratory Owner DOH-3519d - (PDF -- 215K)
• Notification of Change in Laboratory Location DOH-3519e - (PDF -- 215K)
• Notification of Change to Add/Delete Analytes DOH-3519f - (PDF -- 88K)
• Notification of Change to Add/Delete Category(ies) DOH-3519g - (PDF -- 61K)

Limited Service Laboratory Registration

• Limited Service Laboratory Registration Application
  DOH-4081 (Rev.2/09) - (PDF -- 205K)
• Limited Service Laboratory Registration Instructions
  DOH-4081i (Rev.2/09) - (PDF -- [an error occurred while processing this directive])
• Notification to Add Permanent Testing Location to a Multi-Site Network Instructions
  DOH-4081MSi (Rev.2/09) - (PDF -- 27K)
  Notification to Add Permanent Testing Location to a Multi-Site Network Application
  DOH-4081MS (Rev.2/09) - (PDF -- 25K)
• Limited Service Laboratory Registration Notification of Change in Laboratory Name
  DOH-4236f (Rev. 1/08) - (PDF -- 32K)
• Limited Service Laboratory Registration Notification of Change in Laboratory Director
  DOH-4236b (Rev. 9/07) - (PDF -- 141K)
• Limited Service Laboratory Registration Notification of Change in Laboratory Owner
  DOH-4236c (Rev. 5/08) - (PDF -- 456K)
• Limited Service Laboratory Change in Laboratory Location
  DOH-4236d - (PDF -- 27K)
• Limited Service Laboratory Registration Notification to Add and/or Delete Analyte(s)
  DOH-4236e (Rev. 11/08) - (PDF -- 54K)
• Limited Service Laboratory Practice Standards for Blood Lead Screening
  (Rev. 7/09) - (PDF -- 33K)

Patient Service Center Application

• Application and Instructions for Patient Service Center
  DOH-1589i and DOH-1589 - (PDF -- 747K)

Health Fairs (Community Screening)

• Instructions for Health Fairs DOH-HFi - (PDF -- 18K)
• Application for Health Fairs DOH-HF - (PDF -- 65K)

Non-Permitted Laboratory Test Request

• Request Approval Instructions (PDF -- 191K)
• Request Approval Form (PDF -- 76K)

Cytotechnologist Registration and Workload Forms

• Initial Application Instructions DOH-2571i - (PDF -- 16K)
• Initial Application DOH-2571 - (PDF -- 84K)
• Changes in Registration Status Instructions DOH-2571a - (PDF -- 17K)
• Changes in Registration Status DOH-2571a - (PDF -- 84K)
• Application for Approval to Exceed Cytotechnologist Work Standard DOH-3796 - (PDF -- 136K)

These documents are available as Adobe Portable Document Format (PDF) files.
The Adobe Acrobat Reader software is required to view and print these documents. [HELP with PDF files. Requests for the document in an alternate format can be requested by sending an e-mail note to CLEP@health.state.ny.us.