Conn. Agencies Regs. § 19a-36-A47

Current through November 7, 2024

Section 19a-36-A47 - Plasmapheresis centers and blood collection facilities: Definitions

For the purposes of sections 19a-36 -A47 to 19a-36 -A55 inclusive, the following definitions shall apply:

(a) "Advisory Committee on Plasmapheresis and Blood Banking" means a group of consultants, appointed by the state commissioner of health and serving in a voluntary capacity, to advise the department of health on matters relating to the regulation of plasmapheresis and blood banking. Two of the consultants shall be physicians licensed to practice in Connecticut who are in charge of blood banking facilities in hospitals licensed in accordance with sections 19a-A490 to 19a-A503 of the general statutes; one shall be a physician licensed to practice in Connecticut who is associated with or employed by a plasmapheresis or blood banking center which is not a part of a licensed hospital; one shall be a physician who is licensed to practice in Connecticut, is board-certified in clinical pathology, and is the director of a hospital laboratory registered and approved in accordance with sections 19a-36-A25 to 19a-36-A35 and section 19-4-1 of the public health code; and one shall be a licensed physician who is not associated with a plasmapheresis center or blood banking facility. The commissioner of health, if he deems it necessary, may appoint additional consultants to this advisory committee.

(b) "Department" means the state department of health.

(c) "Director" means the person designated by the registrant to be responsible for the daily technical and scientific operations of the plasmapheresis center or blood banking facility including the choice and application of methods, daily technical and scientific operations, donor selection and care, phlebotomies, and reintroduction of red cells as appropriate.

(d) "Center" means any area where plasmapheresis, plateletpheresis or blood banking operations are conducted.

(e) "Plasmapheresis Center" means any area where blood is removed from a human being to obtain plasma, its components, or the non-erythrocytic formed elements with subsequent reinfusion of the red cells into the donor.

(f) "Blood Collection Facility" means any area where blood is removed from a human being for the purpose of administering said blood or any of its components to any human being.

(g) "Owner" means any individual, firm, partnership, association, corporation, the State of Connecticut, or any municipality or other subdivision thereof, or any other entity whether organized for profit or not.

(h) "Registrant" means the person in whose name the registration is granted. The registrant shall be the owner, if the center is owned by a single individual, or a responsible officer or representative when the center is owned by a group, partnership, firm, corporation, or governmental agency.

(i) "Specimen" means material derived from a human being or body.

(j) "Donor" means any person, whether for profit or not, who submits to plasmapheresis or allows a unit of blood more or less to be taken from his or her body for the purpose of transfusion or preparation of blood derivatives or components.

(k) "Unit" means 450 milliliters of blood more or less.

(l) "Transfusion" means the intravenous administration of whole blood, packed red blood cells, plasma, and other blood components, fractions, or derivatives to a human being.

Conn. Agencies Regs. § 19a-36-A47

Effective October 25, 1989