Program Requirements

(A) The Program shall be part of a comprehensive hematopoietic progenitor/stem cell collection, processing and transplantation service. (B) A clinical program that includes non-contiguous institutions in the same metropolitan area shall have a single Program Director, common protocols, staff training, quality assessment systems, review of clinical results and evidence of frequent, regular interaction by all members of the multidisciplinary team. (C) A hospital licensed to provide a hematopoietic progenitor/stem cell transplantation program shall provide or arrange for collection and processing of hematopoietic progenitor/stem cells through collection facilities or services and cell processing laboratories that meet (FACT) accreditation standards. Collection facilities and/or processing laboratories serving one or more clinical transplantation programs are acceptable. (1) If the collection facility or service used by the hospital transplantation program is located outside the United States, the collection facility must be affiliated with the National Marrow Donor Program (NMDP) or the World Marrow Donor Association (WMDA). (2) The cell processing facility shall be: (a) for facilities located within Massachusetts, a licensed, federally certified clinical laboratory, as defined under 42 USC 263A (the Clinical Laboratory Improvement Amendments); (b) for laboratories located outside Massachusetts but within the United States, a federally certified clinical laboratory, as defined under 42 USC 263A (the Clinical Laboratory Improvement Amendments); or (c) for laboratories located outside of the United States, a laboratory that is affiliated with the National Marrow Donor Program (NMDP) or the World Marrow Donor Association (WMDA). (D) Autologous hematopoietic progenitor/stem cell transplantation may be performed in a separately licensed freestanding clinic if: (1) the clinic transplantation services are a formal part of a hospital-based transplantation program; and (2) the hospital-based transplantation program has a current, written collaboration agreement with the freestanding separately licensed clinic that describes the services and responsibilities of each entity and complies with the requirements of 105 CMR 130.536.