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ACFs that Conduct Simple Laboratory Tests On-site Must Register with DOH's CLEP

The New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has issued a letter clarifying that adult care facilities (ACFs) that perform certain simple laboratory tests on-site are subject to oversight by the New York State Department (Department) of Health’s CLEP and must register as such. Click here for the letter. Unfortunately, the link in the letter is incorrect; click here for the proper website, which will provide access to: 

  • Limited Service Laboratory Registration Application, form DOH-4081 (and instructions);
  • Amendments to Article 5, Title V Public Health Law; and
  • New York State Guidance for following Standard Practices in Laboratory Medicine (for sites performing waived and/or provider-performed microscopy procedures under a Limited Service Laboratory Registration).

In addition, the Department has provided a Frequently Asked Questions document, which we encourage you to review.

The Department notes that your completed application to the CLEP should be submitted by mail only (with your registration application fee). Questions should be directed to Stephanie H. Shulman, M.P.H., M.S., M.T. (ASCP) at 518-402-2971, James Holland at 518-402-4141, or CLEPltd@health.ny.gov.

Contact: Diane Darbyshire, ddarbyshire@leadingageny.org, 518-867-8828