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 58-5 - Hematopoietic Progenitor Cell Banks › Section 58-5.2 - General requirements

Current through Register Vol. 46, No. 28, July 10, 2024
(a) A
					 hematopoietic progenitor cell procurement service shall possess a license
					 issued under Subpart 52-2 of this Title in the category of either limited
					 tissue procurement service or comprehensive tissue procurement service, and
					 operate under standards established by this Subpart, Subpart 52-2 except
					 section
					 52-2.9, and one
					 or more licensed hematopoietic progenitor cell transplantation facilities.
					 Unless the procurement service and the transplantation facility are operated by
					 the same institution, a hematopoietic progenitor cell procurement service shall
					 have a written agreement with the transplantation facility, which specifies
					 that hematopoietic progenitor cells collected and stored by the hematopoietic
					 progenitor cell procurement service are acceptable for transplantation by the
					 hematopoietic progenitor cell transplantation facility. Collection of
					 hematopoietic progenitor cells performed at facilities outside New York State
					 shall follow policies and procedures consistent with this Subpart.
					 Documentation of such policies and procedures shall be maintained by each
					 associated hematopoietic progenitor cell transplantation facility.
					 Hematopoietic progenitor cells collected outside New York State shall be
					 approved for use in New York State, in writing, by the director of the
					 hematopoietic progenitor transplantation facility or by a physician designated
					 by the director.
(b) A
					 hematopoietic progenitor cell processing facility shall possess a license
					 issued under Subpart 52-2 of this Title in the category of tissue processing
					 facility, and be associated with and operating under standards established by
					 one or more licensed hematopoietic progenitor cell transplantation
					 services.
(c) A hematopoietic
					 progenitor cell transplantation facility shall possess a license issued under
					 Subpart 52-2 of this Title in the category of tissue transplantation
					 facility.
(d) Hematopoietic
					 progenitor cell procurement services, hematopoietic progenitor cell processing
					 facilities and hematopoietic progenitor cell transplantation facilities may
					 operate independently, or together as part of the same organization.
(e) The director of a hematopoietic
					 progenitor cell procurement service and/or processing facility shall ensure the
					 development and implementation of policies and procedures consistent with this
					 Subpart for the operation of the service and the appointment of a medical
					 director and a medical advisory committee.
(1) The director of a hematopoietic
					 progenitor cell procurement service collecting hematopoietic progenitor cells
					 from peripheral blood shall be a physician and have at least one year's
					 experience in apheresis, including or supplemented by experience in the
					 performance or supervision of at least 25 peripheral blood hematopoietic
					 progenitor cell collection procedures. The director of a hematopoietic
					 progenitor cell procurement service collecting bone marrow shall be a physician
					 and have at least one year's experience in bone marrow collection, including or
					 supplemented by experience in the performance or supervision of at least 12
					 bone marrow collection procedures. The director of a hematopoietic progenitor
					 cell procurement service collecting cord blood only shall be a physician and
					 have at least one year's experience in hematopoietic progenitor cell
					 collection, including or supplemented by experience in the performance or
					 supervision of at least 25 hematopoietic progenitor cell collection procedures.
					 Such director shall also demonstrate satisfactory knowledge in the area of
					 hematopoietic progenitor cell collection, with particular emphasis on the
					 unique characteristics of cord blood collection. A person who has been approved
					 by the department to direct a hematopoietic progenitor cell procurement service
					 as of the effective date of these amendments shall be deemed to qualify as
					 director.
(2) The director of a
					 hematopoietic progenitor cell processing facility shall possess a doctoral
					 degree in the biological sciences and have at least three years' laboratory
					 experience, including at least six months' experience in a clinical laboratory
					 or blood bank. In addition, the director of a hematopoietic progenitor cell
					 processing facility shall have one year's experience in hematopoietic
					 progenitor cell processing, including or supplemented by experience in the
					 performance or supervision of at least 25 hematopoietic progenitor cell
					 processing procedures. A person who has been approved by the department to
					 direct a hematopoietic progenitor cell processing facility as of the effective
					 date of these amendments shall be deemed to qualify as director.