CHARLOTTE, North Carolina – A panel of experts sounded off about everything from stem cells to government legislation and how such things are impacting the laboratory industry, not just circa 2006, but also going forward.

Anthony Kurec, administrator of the department of pathology at the State University of New York-Syracuse, told attendees at the CLMA's (Wayne, Pennsylvania) ThinkLab '06 conference at the Charlotte Convention Center that stem cells aren't going to be the subject of debate only in Congress or at the White House. These potential therapies will present issues in their own labs as stem cells ultimately are used to treat a variety of diseases – and in some cases already are.

"As lab professionals you are required to provide a high level of services," he said, but then posed the corollary difficult question: "How do you feel about patients donating their embryos?"

While embryos are one source of stem cells, umbilical cord blood is another, and it can be stored in a variety of public banks. "People have been entrepreneurial about this and developed private [blood] banks," Kurec said, noting the emergence of this industry.

He added that stem cells, from either source, bring with them complex political and legal concerns.

As one possibility, he cited the hypothetical divorce of a couple that has been attempting in vitro fertilization. Legally, the embryos are considered "property," and so which partner gains "ownership?"

Another example he suggested – even more hypothetically, but also quite possible – was of a couple that has a second child for the purpose of providing stem cells in the event their first child develops a life-threatening disease.

Political concerns will be of a moral nature, involve informed consent, the potential for exploitation of women and coercion, all interlocking in nature and expanding the complexity, he said.

Earl Buck, most recently the administrator of molecular diagnostics at Duke University Hospital Systems (Durham, North Carolina) and now vice president of operations at Chi Solutions (Ann Arbor, Michigan), which calls itself the largest dedicated laboratory management and consulting organization in the U.S., addressed issues related to the nascent field of molecular diagnostics.

First, he asked the rhetorical question, "Why molecular diagnostics?" – and answered, "speed of diagnosis," describing it as a technology that isn't just emerging but is "quickly emerging" and with the menu of molecular diagnostic tests "exploding."

One of the difficulties in moving rapidly forward with molecular diagnostics, he said, has been lack of a single clear definition of the term itself.

And who should perform these tests is even an issue, he noted, saying that some in the healthcare community believe molecular diagnostics laboratory activities should be designated for pathologists and not for technicians.

Buck pointed to various implications for staffing labs that do molecular diagnostics, since it requires a high level of expertise to accomplish successfully. Where are these lab employees going to come from? Will they be basic techs or graduate-trained? And Buck noted a variety of opportunities for PhDs trained in this area, from larger lab companies to biotechnology companies.

Echoing a concern introduced earlier during the ThinkLab conference, Buck said that intellectual property on DNA tests developed at academic centers such as Duke need to remain with the institution, rather than having them pushed out and commercialized. Commercialization, he noted, has often required Duke to pay royalties on tests on technology discovered at the university itself.

He advised not only educating physicians on molecular testing, but also consumers. "Keep in touch with the public," Buck said. "There are people who may want to know if they have a propensity for a specific disease."

Robin Stombler, president of Auburn Healthcare Strategies (Arlington, Virginia), covered quality initiatives and new laws such as PL 109-41, signed into law last July, which creates patient safety organizations (PSOs). For these, the government is providing some assistance, but there is no federal funding available.

She said that among the quality initiatives under way is one launched in 2000 by the American Medical Association (Chicago), called the Physician Consortium for Performance Improvement.

The emphasis of any PSO initiative should be to reduce the 98,000 medical errors resulting in death identified by the Institute of Medicine (IOM; Washington) study, Stombler said. No one knows which of those 98,000 errors resulted from the "over-use, under-use or misuse of diagnostic labs." And so she said that the importance of a laboratory organization such as the Institute for Quality Medicine is to investigate such an issue.

It is also important, she said, because laboratory services support 74% of all diagnoses.

Jeffrey Boothe, an attorney with Holland & Knight (Washington), addressed pay-for-performance (P4P). He said the Medicare Payment Advisory Commission, or MedPAC, which advises Congress on issues impacting Medicare, is concerned that costs for laboratory services have increased 9% since 2003. That increase is primarily due to technology and instrumentation costs, he said.

And the laboratory community needs to revisit lab reimbursement, he said, because not enough rewards are being created in light of its valuable services to healthcare, such as in the emerging areas of pharmacogenomics.

He noted that some have suggested there is over-utilization of laboratory services by physicians. But in an "increasingly litigious society" those in the laboratory field should determine how much of this is "defensive medicine" and how much is directly related to patient care, Boothe said.