A two-year effort to establish uniform standards for bone
marrow, and other cellular transplantation treatments in North
America, has resulted in the implementation of an accreditation
program headed by a faculty member at the University of Nebraska
Medical Center.
The accreditation program also will be headquartered at UNMC.
Phyllis Warkentin, M.D., professor of pathology and
microbiology, and pediatrics, and medical director of UNMC’s
unrelated-donor marrow transplant program, has served as chairman
of the accreditation program of the Foundation for the
Accreditation of Hematopoietic Cell Therapy (FAHCT) since it was
formed in 1995. During the past two years she has devoted time to
establishing the foundation’s office and development of the
accreditation process that the foundation is intended to operate.
The initial tasks are almost complete, Dr. Warkentin said, and
the foundation recently hired an office administrator. To date,
101 facilities across the continent have agreed to participate in
the voluntary accreditation process. Seven of these facilities
already have been inspected. In addition, the foundation has
completed the first edition of FACHT Standards and a companion
accreditation manual to assist transplant programs, cell
collection facilities and cell-processing laboratories in their
efforts to comply with FAHCT standards. The foundation also held
a training workshop last year in Omaha for 80 accreditation
inspectors.
Dr. Warkentin said every facility in North America that
performs at least 10 transplants per year is eligible to
participate in the accreditation process. That would mean between
about 200 to 300 facilities in North America would be able to
participate in the program, she said.
FAHCT was formed after two similar organizations combined
their standard-setting efforts.
The two groups are the International Society for Hematotherapy
and Graft Engineering (ISHAGE), which is a laboratory-oriented
organization, and the American Society of Blood and
Marrow Transplantation (ASBMT), which is a clinical transplant
research organization.
"The clinical group wrote a set of standards, as did the
laboratory group," Dr. Warkentin said. "Then, it was
decided that the process would be better if merged."
The accreditation process is voluntary, she said, but a set of
standards is vital in assuring continued high-quality research
and patient care in the field. In addition, the Food and Drug
Administration has announced its intent to regulate the field of
hematopoietic cell transplantation — but has suggested that it
may be less likely to inspect facilities accredited by FAHCT, if
FAHCT is able to establish and maintain a credible accreditation
program.
"One of the overall goals of this program is to provide
evidence that we can regulate ourselves to achieve measurable
good," Dr. Warkentin said. "Still, the real purpose is
to provide the highest level of laboratory and clinical care for
patients receiving this type of treatment."
Dr. Warkentin was a natural choice to lead the accreditation
effort. She is a member of both ISHAGE and ASBMT. She has worked
in both clinical and laboratory cellular transplantation since
the early 1980s, and has been heavily involved in related
research during the same period. She also
served as chairman of the Standards Committee of the National
Marrow Donor Program, and as a member of the Standards Committee
of the American Association of Blood Banks.
Dr. Warkentin joined the UNMC faculty in 1988. In 1989, UNMC
was accepted as a transplantation center for unrelated-donor bone
marrow transplants. Dr. Warkentin has coordinated the program
since its start.
UNMC is the only public academic health science center in the
state. Through its commitment to research, education and patient
care, UNMC has established itself as one of the
country’s leading centers for cancer research and treatment
and solid organ transplantation. Millions of dollars in research
grants and contracts are awarded to UNMC scientists annually. In
addition, UNMC’s educational programs are responsible for
training more health professionals practicing in Nebraska than
any other institution.