New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter II - Administrative Rules and Regulations › Subchapter D - Laboratories › Part 58 - Clinical Laboratories And Blood Banks › Subpart 58-2 - Blood Banks and Laboratories Performing Immunohematology Testing › Section 58-2.1 - Definitions

Current through Register Vol. 46, No. 28, July 10, 2024
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 of this
					 Part.
(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 hole 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
					 autogenic collection, normovolemic hemodilution, intraperative 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 purposes
					 of reducing red cell loss during surgery.
(w)
Limited reinfusion
					 service
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 required 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.