Code of Massachusetts Regulations › 105 CMR - DEPARTMENT OF PUBLIC HEALTH › Title 105 CMR 130.000 - Hospital Licensure › Subpart D - SUPPLEMENTARY STANDARDS: PARTICULAR SERVICES › Section 130.540 - Application to Provide Hematopoietic Progenitor/Stem Cell Transplantation Program

Current through Register 1525, July 5, 2024
(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.