First, let it be said, and let no one doubt: Neil MacIntyre, MD, isn’t one to complicate the lives of his fellow pulmonologists with even more regulations, even more paperwork.
But it’s just “not right” that the field of pulmonary function testing has no accrediting agency, no overseer, to ensure that labs adhere to minimal operating standards, said MacIntyre, Duke University’s clinical chief of pulmonary medicine and one of the profession’s foremost thought leaders.
“There is a lot of interest in the U.S. and around the world in having some kind of PFT lab certification,” he said. “Right now, there is none. You can buy a piece of equipment, open the door, and tell people you’re a PFT lab.
“I’m not calling for spending lots of money or having on-site inspections,” he stressed, “but it is reasonable to expect these labs to adhere to standards already out there. This is high-tech equipment and important treatment decisions are made on this equipment.”
To address this lack of uniformity-and to protect labs from possibly having to adopt arbitrary or inappropriate standards imposed by an outside authority-the American Thoracic Society, in 2002, created its Pulmonary Function Laboratory Registry. A voluntary registration program, the registry brings together PFT labs that agree to adhere to operating standards established by the ATS and the European Respiratory Society. These labs share information, perform research, and speak as a united front on issues of quality testing.
“We are a beginning,” said MacIntyre, a member of the ATS’s PFT Lab Standardization Committee which created the registry. “It’s the first attempt at getting pulmonary function testing into the world of certification-but voluntary certification.”
Scratching the Surface
Ten years into its life, the registry’s reach and influence remain, in truth, rather modest. Currently, about 200 PFT labs have joined, clearly a minority of U.S. labs.
“We’ve only scratched the surface here,” MacIntyre said. “There are about 5,000 acute care hospitals in the U.S. and most have PFT labs of sorts, plus who knows how many labs there are in group practices around the country. It is a commentary on how pulmonary function testing is viewed. A minority of labs are interested while a bunch of labs don’t seem to be super-involved in meeting all the standards people think they should meet.”
To join the Registry, lab managers complete an application and a questionnaire that confirms their commitment to using ATS/ERS standards when performing PFTs.
“It takes labs through all the ATS/ERS standards and says, ‘I agree to abide by those standards,'” MacIntyre explained. “With that, they can join the registry. They have made a commitment on paper to follow standards.”
A 3-year membership costs ATS members $150 (for administrative fees) and non-members $200.
By collaborating and benchmarking, these 200 labs have generated valuable and mutually beneficial clinical data, according to MacIntyre. “These labs are very good and very enthusiastic about responding to surveys,” he said. “So we have published a number of abstracts about member practices, what reference values they use, what interpretation algorithms they use, abstracts on diffusing capacity, very helpful things. It has resulted in a lot of interest in PFT standards.”
The ultimate goal of the registry is to create a network of laboratories large enough to become influential and have a say in policies governing such matters as reimbursement.
“Our surveys so far have all been scientific and addressed actual practice patterns,” MacIntyre said. “And we’ve done that well. The idea is, if we can get big enough, we can become a voice in discussions with regulators and payers.”
To get there, the registry needs more visibility. “Until recently, the ATS has used mostly paper information, a newsletter twice a year, delivered by snail-mail,” MacIntyre said. “Paper information is notorious for getting lost or otherwise not getting in the hands of the folks to whom it’s intended. Our communication network is not good enough to grow this thing yet. We are more potentiality than actuality now.
“The good news is we are about to get a dedicated, members-only website. That will facilitate much more communication among the labs in the registry and create a really nice communication network to make this registry thrive.”
Registry members will have a password-protected website featuring the newsletter, summaries and abstracts of current and past registry projects, links to important references, and space for member input/communication.
“I’m really hoping we get this web-based communication system up and running to create a much more vibrant system, getting the word out that we believe in these standards,” MacIntyre said.
To obtain registration material and join the ATS Pulmonary Function Registry, contact Bridget A. Nance, Assembly Programs coordinator: 212-315-8695, email@example.com.
Michael Gibbons was formerly on staff at ADVANCE.