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Title: Section 58-4.1 - Definitions

Effective Date


58-4.1 Definitions

(a) Source plasma is defined as the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. This definition excludes single donor plasma products intended for intravenous use (i.e., transfusion).

(b) Source plasma donation center means a facility where source plasma is collected by plasmapheresis, and total protein and hematocrit testing is performed on prospective donors. Source plasma donation center does not include collection of single source donor plasma intended for intravenous use (i.e., transfusion).

(c) Responsible physician means an individual who is:

(1) Licensed and registered to practice medicine by the New York State Education Department;

(2) In good standing with the New York State Education Department and the Office of Medical Professional Conduct of the New York State Department of Health;

(3) Adequately trained and qualified to direct and control personnel and relevant procedures concerning the determination of donor eligibility; collection of blood and blood components; the immunization of a donor; and the return of red blood cells or other blood components to the donor during collection of blood component(s) by apheresis; and

(4) Designated by the collection establishment to perform the activities described in paragraph (c)(3) of this section.

(d)  Physician substitute means a trained and qualified person(s) who is:

(1)  Currently licensed and registered as a health care worker by the New York State Education Department;

(2) Currently certified in cardiopulmonary resuscitation; and

(3) Trained and authorized under State law, and/or local law when applicable, to perform the specified functions under the direction of the responsible physician.

(e) Laboratory director means an individual who meets the qualifications listed under the Code of Federal Regulations including, Title 42, Part 493, Section 1405.


Statutory Authority

Public Health Law, Sections 571 and 575-a


VOLUME A-1 (Title 10)