(A) The provisions of rules
3701-84-24 to
3701-84-27 of the Administrative
Code are applicable to each
blood and bone marrow transplant
service regardless of the date service was
initiated.
(B) Each
blood
and bone marrow transplantation service
will be
located in a hospital classified as a general
hospital, a children's hospital or as a specialty hospital that primarily
furnishes oncology services that meets all of the following criteria:
(1) Participates with other hospitals
nationally in cancer treatment research, such as national cancer institute
sponsored research. The hospital's research activities
should
include all of the following:
(a) Use of
uniform patient treatment protocols;
(b) On-site audits at least every five years
by a cancer research organization or another hospital involved in national
cancer treatment research; and
(c)
Reporting of patient eligibility and treatment data to the research
organization in which the hospital participates.
(2) Meets the following administrative
requirements:
(a) Appropriate patient
management plans and protocols consistent with
nationally accepted standards, including:
(i)
Patient selection
criteria;
(ii)
Plans for long-term management;
(iii)
Protocols to
address the prevention of opportunistic infections among blood and bone marrow
transplant recipients; and
(iv)
Protocols for
liaising with the patient's family and primary care physician.
(b) Quality assurance standards
for the procurement of hematopoietic stem cells including the procurement of
bone marrow via a bone marrow harvest, as well as procurement of hematopoietic
progenitor cells (stem cells) by the use of leukapheresis or umbilical cord
blood collection; and
(c) A
procedure for conducting systematic evaluation of clinical outcomes resulting
from hematopoietic stem-cell transplantation.
(3) Has a documented agreement to cooperate
with other blood and bone marrow transplantation services in Ohio
relative to patient selection that is non-discriminatory as to race, gender,
and ability to pay.
(C)
Prior to initiating transplantation services, the
blood
and bone marrow transplantation service
will specify to
the director:
(1) The type of patient
population to be served:
(a) Pediatric
patients
aged seventeen years
or younger;
(b) Adult patients
aged eighteen or older.
A blood and bone marrow
transplantation service may serve patients greater than or equal to
eighteen years of age as a pediatric or an adult patient,
whichever best serves the needs of the patient, as determined by the transplant
physician and transplant service's medical director;
(2) The type of transplantation
service:
(a) Autologous;
(b) Allogeneic; or
(c) Both.
