N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-5.2

Current through Register Vol. 46, No. 45, November 2, 2024

Section 58-5.2 - General requirements

(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.

(f) Medical direction of a hematopoietic progenitor cell procurement service and/or processing facility shall be provided by a physician in consultation with the medical advisory committee. Such physician shall be licensed and currently registered with the New York State Education Department or in the state or jurisdiction of practice. The medical director of a hematopoietic progenitor cell procurement service shall have two years' experience or training in clinical hematology/oncology that includes experience in bone marrow transplantation or two years' experience or training in transfusion medicine, in addition to either one year's experience in hematopoietic progenitor cell collection, or performance or supervision of at least 25 hematopoietic progenitor cell collection procedures for each anatomic site (bone marrow, peripheral blood, cord blood or other site) to be used as a source of hematopoietic progenitor cells. The medical director of a hematopoietic progenitor cell processing facility shall have two years' experience in clinical hematology/oncology that includes bone marrow transplantation experience, or two years' experience or training in laboratory medicine or transfusion medicine, in addition to either one year's experience in hematopoietic progenitor cell processing, or experience in the performance of supervision of at least 25 hematopoietic progenitor cell processing procedures. A person who has been approved by the department as medical director of a hematopoietic progenitor cell bank as of the effective date of these amendments shall be deemed to qualify as medical director.

(g) The hematopoietic progenitor cell transplantation service director shall be a physician who shall be responsible for compliance with section 52-2.8 of this Title, and shall monitor the medical efficacy of the hematopoietic progenitor cell transplantation program.

(h) The medical advisory committee, which may be the in-house transfusion committee or transplantation committee, shall include experts in the areas of infectious disease, hematology, oncology, histocompatibility and transfusion medicine, as well as physicians representing associated hematopoietic progenitor cell transplantation facilities. The committee shall meet at least annually.

(i) The medical director of a hematopoietic progenitor cell procurement service, in consultation with the medical advisory committee shall monitor the medical efficacy of the program, and in conjunction with the associated hematopoietic progenitor cell transplantation facility shall, as a minimum, develop medical criteria for donor participation.

(j) The medical director of a hematopoietic progenitor cell procurement service shall be responsible for all aspects of donor qualification, as described in section 58-5.4 of this Subpart.

(k) The director of a hematopoietic progenitor cell procurement service and/or processing facility shall be responsible for the technical and scientific operation of the facility, and shall develop quality standards for hematopoietic progenitor cells.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 58-5.2