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Laws, Regulations and Standards

The New York State Council on Human Blood and Transfusion Services, was established in 1973 by Public Health Law Article 31 (see below). The Council enacts and amends regulations affecting the safety of the blood supply in New York State, subject to approval by the Commissioner of Health. These regulations include Subpart 58-2 Blood Banks and Subpart 58-5 Hematopoietic Progenitor Cell Banks. (Hematopoietic progenitor cells are precursors of blood cells found in peripheral blood, umbilical cord blood and bone marrow.) The Council also develops guidelines for the processing and clinical use of blood and blood components, and hematopoietic progenitor cells.

Approval by the Blood Resources Program or by the Clinical Laboratory Evaluation Program is required for facilities that perform blood banking activities or offer any blood services in New York State, from collection through clinical use.

Statutes-Public Health Law
Article 5, Title V: Clinical Laboratory and Blood Banking Services 

  • Navigate to the NYS Legislature resource and enter CLINICAL LABORATORY AND BLOOD BANKING SERVICES in the search box, then click PUBLIC HEALTH LAW ARTICLE 5T5

Article 31: Human Blood and Transfusion Services

  • Navigate to the NYS Legislature resource and enter HUMAN BLOOD AND TRANSFUSION SERVICES in the search box, then click PUBLIC HEALTH LAW ARTICLE 31

Regulations Title 10, NYCRR
Subpart 58-2 Blood Banks and Laboratories Performing Immunohematology Testing
 

Standards
Part 1 General Systems Standards (Effective January 1, 2017)
Part 2 Blood Services Standards (Effective July 14, 2014)