Current through all regulations passed and filed through September 16, 2024
(A)
All candidates
for blood and bone marrow transplantation are subject to prospective patient
selection criteria as specified in appendix A to this rule.
(B)
If a
transplantation service desires to perform a transplant on a patient who does
not meet the selection protocols set forth in appendix A to this rule, the
service is obligated to undertake a thorough review of the case, conducted by a
blood and bone marrow transplant team comprised of members of the service's
ethics, legal, and medical staff, to determine that the transplant is
appropriate and include:
(1)
Preparation of a detailed clinical summary of the
patient that includes:
(a)
A brief medical history;
(b)
Complete
laboratory data related to the diagnosis;
(c)
A thorough
psychosocial evaluation that includes:
(i)
The
identification of the patient's support system, including potential
caregivers;
(ii)
Identification of psychosocial
barriers;
(iii)
Identification of potential barriers and challenges of
the transplant; and
(iv)
The patient's attitude toward the transplant, the
patient's understanding of the transplant, and the patient's understanding of
the treatment, including whether the intention is to be palliative or
curative.
(d)
A justification of the transplant despite failure to
meet the selection criteria; and
(2)
After sufficient
review time, an affirmative vote of a majority of the members of the team that
the transplant is appropriate.
(C)
Each blood and
bone marrow transplantation service should achieve the following volume goals
per year to ensure efficiency and a minimum floor of competency:
(1)
Adult blood and
bone marrow transplantation service performing transplants at a single clinical
site:
(a)
Autologous only transplantation services should perform an
average of at least five autologous transplants per year; or
(b)
Combined
autologous and allogeneic services should perform an average of at least ten
allogeneic transplants per year.
(2)
Adult blood and
bone marrow transplantation service performing transplants at multiple clinical
sites:
(a)
Autologous only transplantation services should perform an
average of at least five autologous transplants per year at each site;
or
(b)
Combined autologous and allogeneic transplantation
services should perform an average of at least five autologous and five
allogeneic transplants per year at each site.
(3)
Pediatric blood
and bone marrow transplantation service performing transplants at a single
clinical site: or
(a)
Autologous only transplantation services should perform
an average of at least five autologous transplants per year; or
(b)
Combined
autologous and allogeneic services should perform an average of at least five
allogeneic and five autologous transplants per year.
(4)
Pediatric blood
and bone marrow transplantation service performing transplants at multiple
clinical sites:
(a)
Autologous only transplantation services should perform
an average of at least five autologous transplants per year at each site;
or
(b)
Combined autologous and allogeneic transplantation
services should perform an average of at least five autologous transplants per
year at each site.
(5)
Combined adult
and pediatric blood and bone marrow transplantation services performing
transplants at a single clinical site:
(a)
Autologous only
transplantation services should perform an average of at least five pediatric
autologous transplants and five adult autologous transplants per year;
or
(b)
Combined autologous and allogeneic services should
perform an average of at least five pediatric allogeneic transplants and five
adult allogeneic transplants per year.
(6)
Combined adult
and pediatric blood and bone marrow transplantation services performing
transplants at multiple clinical sites:
(a)
Autologous only
transplantation services should perform an average of at least five autologous
transplants per year at each site; or
(b)
Combined
autologous and allogeneic transplantation services should perform an average of
at least five pediatric and five adult autologous transplants per year and and
at least five pediatric allogeneic and five adult allogeneic transplants per
year at each site.
(D)
Volume goals may
be considered by the director in conjunction with other indicators of quality,
not as the sole indicator of service performance.
Replaces: 3701-84-27
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