Application to Provide Hematopoietic Progenitor/Stem Cell Transplantation Program

(A) A hospital licensed or operated by the Commonwealth pursuant to M.G.L. c. 111, § 51, that provides or is seeking to provide an hematopoietic progenitor/stem cell transplantation program shall provide documentation to the Department that it has received and maintains accreditation by (FACT). A copy of (FACT) accreditation documentation shall be submitted to the Department upon receipt from (FACT). (1) Hospitals seeking to initiate an hematopoietic progenitor/stem cell transplantation program and hospitals providing autologous or allogenic hematopoietic progenitor/stem cell transplantation services that intend to expand the transplantation program to also provide allogeneic or autologous transplantation services shall submit to the Department at least 90 days prior to performing the first transplant, a written statement signed under pains and penalties of perjury by a person authorized to act on behalf of the applicant that attests that the applicant’s transplantation service meets the (FACT) accreditation standards, except for the transplant volume requirement, that the hospital will file an application for accreditation by (FACT) once the program has completed, within a 12 month period, ten of each type of transplant (allogeneic or autologous) for which it seeks accreditation, and the hospital will provide written confirmation of the filing of the accreditation application. (2) Subsequent to receipt of the information required by 105 CMR 130.540(A)(4), the Department shall grant a provisional license for the service that identifies the type of transplant to be performed. (a) Within 30 months from the date of the issuance of the provisional license, the hospital shall file the (FACT) accreditation application(s) and provide the Department with written confirmation of the filing. (b) If the hospital fails to file the (FACT) application within the specified time period, the Department shall notify the applicant that the Department has not received satisfactory written documentation of filing for accreditation by (FACT) and offer the applicant the opportunity to submit the documentation within two weeks or such other time period as the Department shall define. (c) If the applicant fails to submit the documentation required by 105 CMR 130.540(A)(5)(a) or (b), the Department shall revoke the provisional license and, without further hearing, refuse to issue a license for the transplantation program. (d) If satisfactory written documentation of accreditation by (FACT) by type of transplant performed is not received by the Department within one year from the application date for accreditation, the Department shall notify the applicant that the Department has not received documentation of accreditation by (FACT) and offer the applicant the opportunity to submit the documentation within two weeks or such other time period as the Department shall define. (e) If the applicant does not submit the documentation required by 105 CMR 130.540(A)(5)(d), the Department shall revoke the provisional license and, without further hearing, refuse to issue a license for the transplantation program. (B) In its letter of application, a hospital shall describe its hematopoietic progenitor/stem cell transplantation program including, but not limited to, identification of the Transplant Program Director, the patient population, type of service, location and size of the service and any portions of the service that are outside of the licensed applicant facility.