Tissue Services Director Margery Moogk

This issue of RESOURCE reports on the latest developments in some of Northwest Tissue Services’s programs and operations, and in this column, I will introduce several of those articles, as well as provide an update on other programs.

NAT Testing
First, all of us at the Tissue Services are proud of the roles we played in helping manufacturers license nucleic acid testing (NAT) kits for use on cadaveric blood samples, and in lobbying the American Association of Tissue Banks to make NAT testing mandatory for accredited banks (see NAT and Tissue Banking—The Time has Come).

We have been anxious to implement NAT for the extra level of safety it adds. In fact, we started NAT on prospective donors last August, soon after Chiron licensed the first assay. We have also chosen to test donors in quarantine and those with tissue still in our inventory, although there is no requirement to do so, and currently most banks do not plan to. Again, we believe this is the most responsible decision for our future transplant recipients.

The overall benefit is a relatively small margin of increased safety, but it’s an important one. Anytime the Tissue Services can implement changes that provide a higher level of assurance in the safety and quality of our tissue, we will, because it means we are better serving the community.

New Standards
The Food and Drug Administration (FDA) has published final regulations on donor eligibility and good tissue practices. They become effective in 2005. There are also new AATB standards. We’ve reviewed our current practices and find few changes that we need to make. We will be in compliance with these new standards and regulations by the time they are fully implemented.

We’ve been active in helping to define the AATB standards and have had ample opportunity to influence the new FDA regulations, so there are very few surprises; in fact, we’ve been working toward compliance for some time in anticipation or their publication

Partnership Progress
We have begun distributing tissue grafts processed by one of our partners, Musculoskeletal Tissue Foundation (MTF). As of the end of January 2005, we have shipped more than 500 grafts to 34 hospitals in the three-state region.

MTF processes Tissue Services-provided bone into precisely tooled bone grafts that are easily implanted during spinal surgery. Developed by MTF and Synthes Spine, L.P., the MTF/Synthes allografts enable surgeons to perform spinal fusions and enhance patient recoveries.

MTF also processes demineralized bone into DBX paste, putty, and mix from our donors, all easy to deliver and widely used throughout the region. More than 2,000 of these allografts were used by our hospitals in 2004. We’re very happy that in 2005, these allografts will be coming from regional donors.

We’ve found our new relationships with our Syntheses consultants to be good ones. They are enthusiastic about their role in representing these products in our regional hospitals where our reputation is already good. They have been eager to learn about the Tissue Services and pleased to have the allografts available locally. That has already made a difference to patient care.

The relationship with our other partner, Osteotech, Inc., has not yet progressed to the point of having tissue to distribute, but we anticipate that we will soon be able to offer the company’s Grafton® brand of demineralized bone matrices, also processed from Tissue Services-provided bone.

These allografts can be used in a variety of surgeries and dental procedures in which new bone growth is important.

In both of our partnerships, we’re excited about recent progress and very optimistic about the future.

Cord Blood Program
We are very proud to report that we have now distributed nine cord blood units for transplant and also that we have another 13 on hold for potential distribution.

There are indications that these latter units would be appropriate for specific patients, and transplant centers are in the process of further evaluating them—each unit is checked for compatibility with the intended recipient and may be compared with potential matching units from other banks.

When transplant teams comb through donor registries for potential matches, they examine progressively more specific tissue typing criteria. Such typing is performed either at the transplant center or here at Puget Sound Blood Center’s Immunogenetics Laboratory. Our conversion rate is one of five “holds” that are actually ordered for transplant.

Reactivated
The Tissue Services’s Islet Cell Transplant Program is again poised for action. We’re hoping to perform several islet cell transplants at Swedish Hospital in the next six months.

The Seattle consortium of participating health care institutions will utilize a protocol that differs from those used in the first two rounds of islet transplants in 2002-2003. This time, the pancreatic islet cells will be transplanted into patients who have already had kidney transplants.

Since the candidates will have been taking immunosuppressive drugs, hopefully, islet cells introduced under that same regimen will have a better chance of surviving and functioning.

The Tissue Services team is led by Jo-Anna Reems, Ph.D., who has been working closely with Dr. Bill Marks’ transplant team at Swedish that includes the laboratory’s medical director, Andrew Precht, M.D., and transplant coordinator Terry Baker.

In the RESOURCE issues ahead, we’ll continue to report on the work of Dr. Reems and the Islet Cell Transplant team, as well as the progress being made in other Tissue Services programs. Tissue banking continues to offer many challenges and opportunities. We are grateful for the many community partners and donor families who make our work possible.