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On-Site Survey Process

Laboratories seeking a permit must have an initial on-site survey before a permit is issued and before patient testing can be performed. A surveyor from the Department will contact the laboratory to schedule an initial on-site survey. Out-of-state surveys are announced but subsequent routine surveys of in-state laboratories are unannounced. Please note that a survey cannot be scheduled until the laboratory has participated in any required proficiency testing and has submitted validation in accordance with our Submission Guidelines, if required.

The purpose of the survey is to ensure that the premises, laboratory practice, equipment, personnel, and record-keeping meet state requirements. These requirements are outlined in Article 5, Title V of the New York State Public Health Law, Parts 19, 58, 63 and 70 of Title 10, New York Code of Rules and Regulations (10NYCRR), and in the New York State Clinical Laboratory Standards of Practice.

New York State Public Health Law requires that out-of-state laboratories seeking or reapplying for a clinical laboratory permit pay the travel expenses related to the on-site survey. Travel expenses are based on the number of surveyors involved in the survey, the number of days required for the survey, and the number of facilities surveyed. Laboratories are sent a bill for these expenses after the survey is completed. Survey expenses for in-state laboratories are included in the annual permit fees.

On-Site Survey Process

Survey Materials


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