Laboratory Standards | New York State Department of Health, Wadsworth Center

Standards Open for Comment

Proposed revisions to the New York State Clinical Laboratory Standards of practice, General Systems and Specialty Requirements by Category, are available for review and comment.

Please send comments regarding these proposed changes to clep@health.ny.gov no later than September 4, 2026. Please include the words Standard Revision in the subject line of any emails related to this announcement.

Comments, Responses, and Revisions to General Standards Reporting - February 2026

Responses to comments received during the General Systems Standards Reporting open comment period.

General Systems Standards Reporting Comment Repsonses

Summary showing revisions to the General Systems Standards Reporting. Changes are effective February 12, 2026.

General Systems Standards Reporting Revision Summary February 2026

Comments, Responses and Revisions to Specialty Requirements - Histocompatibility and Pathology Categories – February 2026

Responses to comments received during the Specialty Requirements - Histocompatibility and Pathology categories open comment period.

Summary showing revisions to the Specialty Requirements - Histocompatibility and Pathology categories. Changes are effective February 12, 2026.

Current Standards

Clinical Laboratory Standards of Practice

General Systems Standards - Effective February 2026

Specialty Requirements by Category

Additional Materials and Policies

Clarification on Clinical Laboratory Testing Personnel Requirements; glucometry

Revised Remote Activities Policy

NYS Cytogenetics Quality Assurance Program Chromosome Microarray Analysis policy

IQCP Requirements CLIA To NYS - May 2021