Title: Section 58-2.1 - Definitions

Effective Date

09/27/2015

Section 58-2.1 Definitions. As used in this Subpart:

(a) Blood bank means a facility for the collection, processing, storage or distribution of human blood, human blood components or derivatives, or the performance of reinfusion procedures. A blood bank shall employ a qualified director for administrative purposes and, if blood collection is performed, a qualified medical director.

(b) Blood donation center means a fixed satellite location operated by a blood bank and used for the collection of whole blood and/or blood components.

(c) Donor or blood donor means a person who provides his/her blood or plasma for transfusion of whole blood, blood components or derivatives.

(d) Blood components means those preparations separated from a single donation of whole blood, or collected by apheresis, intended for direct use in transfusion, including, but not limited to plasma, fresh frozen plasma, plasma frozen within 24 hours after phlebotomy (FP24), red blood cells, washed red blood cells, leukocyte-reduced red blood cells, platelets, granulocytes and cryoprecipitate, but does not include lymphocytes collected from a donor of hematopoietic progenitor cells, as defined in Subpart 58-5.

(e) Derivatives means those preparations separated from plasma derived from multiple donors, including but not limited to albumin, immune globulin, plasma protein fraction and clotting factor concentrates.

(f) Blood products means whole blood, blood components or derivatives.

(g) Plasmapheresis means the withdrawal of blood to obtain plasma with subsequent or simultaneous reinfusion into the donor of his/her own red blood cells.

(h) Serial plasmapheresis program means a program of individual donor donations on a regular basis by plasmapheresis yielding three liters or more of plasma per consecutive four-week period.

(i) Cytapheresis means the separation and collection of blood cells or other formed elements by hemapheresis for the purpose of obtaining a transfusable blood component.

(j) Intraoperative blood recovery means recovery of blood from a surgical field and processing of recovered blood for direct reinfusion, storage or infusion into a cardiopulmonary bypass pump. Intraoperative blood recovery does not include performance of perioperative normovolemic hemodilution procedures. Postoperative blood recovery means recovery of blood from a wound following surgery, and processing of recovered blood for direct reinfusion or storage. Intraoperative blood recovery was formerly termed intraoperative blood salvage.

(k) F.D.A.means the Food and Drug Administration of the United States Department of Health and Human Services.

(l) Limited transfusion service means a facility, home care services agency, physician's office, or other entity which administers blood or blood components, and may temporarily store blood or blood components, and distribute them within its own organization, but relies on a blood bank holding a permit in blood services-transfusion to perform laboratory tests required under section 58-2.17 of this Subpart.

(m) Distribution facility means a facility at which blood and blood components are temporarily stored prior to distribution.

(n) Transfusion service means a service that issues blood or blood components for administration into a person, but does not include a limited transfusion service or an ambulance transfusion service.

(o) Institution means a hospital or other facility operating a transfusion service under a permit issued by the department.

(p) Allogeneic collection means the removal and storage of blood or blood components from a donor for transfusion into another person, and includes blood donated for directed donation to another person, or donated for autogeneic use and subsequently crossed-over in whole or in part for use by others. Allogeneic collection was formerly termed homologous collection.

(q) Autogeneic collection means the removal and storage of blood or blood components from a donor for subsequent reinfusion into that same person, and includes preoperative hemodilution procedures if at any time the blood leaves the operating room in which surgery is performed. Autogeneic collection was formerly termed autologous collection.

(r) Directed donation means an allogeneic collection in which blood from a particular donor is designated for use by a specified recipient.

(s) Medical director means a qualified physician who is employed by a blood bank, and is responsible for donor selection and safety.

(t) Department means the New York State Department of Health.

(u) Reinfusion procedure means the withdrawal of blood or a component thereof from a patient, its processing and administration of the product so obtained, in whole or in part, into the same patient for diagnostic or therapeutic purposes. Such processing may include, but is not limited to, separation ( e.g.into platelet-rich plasma or fibrin glue), radioisotopic tagging, and genetic and immunologic manipulation. Reinfusion procedures shall not include presurgical autogeneic collection, normovolemic hemodilution, intraoperative blood recovery or postoperative blood recovery.

(v) Normovolemic hemodilution means the collection of blood prior to surgery, and includes fluid replacement and reinfusion during or after surgery for purposs of reducing red cell loss during surgery.

(w) Limited reinfusionservice means a facility, home care services agency, physician's office or other non-hospital entity that performs reinfusion procedures.

(x) Clinical laboratory technician means a clinical laboratory practitioner who performs clinical laboratory procedures and examinations, pursuant to established and approved protocols of the department, which require limited exercise of independent judgment, and are performed under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory.

(y) Clinical laboratory technologist means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department, performs clinical laboratory procedures and examinations and any other tests or procedures conducted by a clinical laboratory, including maintaining equipment and records, and performing quality assurance activities related to examination performance, which require the exercise of independent judgment and responsibility.

(z) Health care provider, for the purposes of this Subpart, means a physician, physician assistant or nurse practitioner.

(aa) Nurse practitioner means a registered professional nurse licensed and currently registered, under the Laws of the State of New York, to diagnose illness and physical conditions, and perform therapeutic and corrective measures, in accordance with a collaborative agreement with a physician qualified to collaborate in the specialty involved.

(ab) Physician means an allopathic or osteopathic physician licensed and currently registered, under the Laws of the State of New York or in the state of practice, to practice medicine.

(ac) Physician assistant means a person licensed and currently registered, under the Laws of the State of New York, to practice medicine under the supervision of a physician.

(ad) Physician designee means a physician designated by the medical director to be responsible for one or more routine or special tasks.

(ae) Ambulance transfusion service means an ambulance service certified by the department that administers blood components during transport from one hospital to another hospital.

(af) Hospital, for the purposes of this Subpart, means a general hospital.

Volume

VOLUME A-1 (Title 10)

up