(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.
