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Clinical Laboratory Evaluation Program - Survey Standards

New York State Public Health Law, Article 5 Title 5 provides the Department with the authority to establish minimum standards for laboratory practice. These Clinical Laboratory Standards of Practice, along with applicable regulations and statute, are used to conduct on-site surveys of laboratories as a condition to obtaining or maintaining a valid laboratory permit. Surveys may also be conducted in response to reports of complaints or other incidents. Standards are published as Proposed Standards and distributed to all laboratories for a formal comment period prior to adoption, although feedback on our standards is encouraged at any time. Click on the links below to review Standards that are adopted, those that are current and in effect, and those that are open to formal comments. Also included is a link to educational materials regarding survey requirements.

Questions and comments concerning standards interpretation and development can be directed to the Clinical Laboratory Evaluation Program at 518-485-5378 or clep@health.ny.gov.

Laboratory Survey Standards

Standards Open for Comment HTM
Recently Adopted Standards HTM
Current Standards HTM
Survey and Standards Educational Materials HTM

Statute and Regulations

Clinical Laboratory Statute and Regulations HTM