In fiscal years 2005 and 2006, the U.'s program did fewer than 10 transplants - the minimum number required by the United Network for Organ Sharing (UNOS) and Medicare to ensure clinical competency.

Jeannie Miller, director of Medicare's division of institutional quality standards, acknowledged there are no studies directly linking volume with quality.

However, "we still have a belief at [Medicare] that there has to be some kind of link - you have to have the knowledge and the ability and the skills," Miller said. "If you only do one a year, are you as proficient as someone who does 10 a year?"

UNOS has the authority to revoke a program's certification as a transplant center, and Medicare could withdraw its approval. Neither move is likely, said Kim Phillips, a registered nurse and the U. program's administrator.

UNOS asked the U. a year ago to begin submitting quarterly data on its transplants, and has indicated it will help the program get more surgeries, he said.

"The reality of our waiting list is, if you don't have enough patients on your list, you won't have the volume to maintain clinical competence," Phillips said.

Reversing the trend

Hoping to bolster its program, the U. has added another surgeon to its team and is reaching out to patients beyond the Salt Lake City area, even into other states, to increase its referrals.

In the past couple of months, the U. performed three transplants, and its waiting list has doubled.

While larger transplant clinics can have waiting lists with up to 500 patients, the U.'s program staff is excited to have the largest number it has seen in awhile: eight.

"The more recent trend is what will carry us through the future," Phillips said.

The recent low number of transplants has skewed the U.'s patient survival rates, he added.

At the U., about 64 percent of adult patients are still alive one year after their lung transplant, compared with the 85 percent who are expected to be alive, according to the Scientific Registry of Transplant Recipients.

The registry takes into account patient characteristics such as age, disease and blood type, and the U.'s shortfall remains "statistically significant," it said.

But Phillips responded: "As your volume drops, one death, two deaths, can dramatically sway your results."

Started in 1992, the U.'s lung transplant program is the only one in the Intermountain West, and its patients hail from as far as Idaho, Nevada, Montana and Wyoming. Despite one of the lower organ wait-list times in the county, the program has seen its patient numbers dwindle over the last two years.

A combination of new treatment options available to patients who would otherwise need a new organ, a drop in chronic obstructive pulmonary disease (COPD) diagnoses and a lack of awareness of the transplant program may partially explain why.

But, Phillips said, "we can't really put our finger on anything that has caused it."

Stricter oversight

Until now, the 400-some transplant centers nationwide were expected to self-report any significant changes in their programs. The government also relied on patients' complaints to trigger reviews or surveys of transplant centers.

But Medicare's new rules, slated to take effect in about 90 days, set up a certification process already used for other facilities, such as hospitals, Miller said.

As organ transplants evolved from an experimental treatment to standard practice, the need for more oversight became clear, she said.

Between 1988 and 2006, nearly 400,000 organ transplants have been performed nationwide; in Utah, that number is 4,000, according to UNOS.

The new rules will give transplant centers six months to re-apply for a three-year Medicare approval, Miller said.

Centers not in compliance will have 10 days to submit a corrective plan and may receive site visits.

It is unclear how many transplant centers may be in danger of losing their Medicare certification, Miller said, but a preliminary review of their data six months ago revealed that about 20 failed to meet the standards.

She declined to say which centers those were.

Phillips said the U.'s lung program intends to explain in its application the special circumstances surrounding its low volume and patient survival rate.

In the meantime, Phillips said he is hopeful the program will have all of the resources it needs to continue.

"We're very much interested in it [the Medicare approval process], and it will be something we'll be focused on in the next two to three months," he said.

lrosetta@sltrib.com