NEW YORK – This April, the Clinical Laboratory Improvement Advisory Committee (CLIAC) met in Baltimore as part of its regular process of advising the US Department of Health and Human Services on issues related to clinical laboratories and laboratory medicine.
Among the matters discussed were potential updates to current CLIA requirements for lab personnel, including the qualifications required of laboratory directors.
While the decision to review these requirements was not driven by any single pressing issue, it was a reflection of changes in the clinical lab as well as in the role played by lab directors, said Lee Hilborne, professor of pathology and laboratory medicine at the University of California, Los Angeles School of Medicine and a member of the CLIA Personnel Regulations Workgroup, which at the meeting recommended several changes to the current lab personnel requirements.
The recommendations will now go to Centers for Medicare & Medicaid Services for review, Hilborne said.
"The group hadn't thoroughly looked at these issues in many years, and they don't address some general areas like bioinformatics or the role of molecular and data analysis and so on," he said. "Since the [CLIA] regulations were written, there are all kinds of new disciplines and activities in laboratory medicine."
According to some observers, these new disciplines are driving changes in the background and training of lab directors. Others noted that increasing administrative and regulatory duties have shifted the job from a more academic, research-focused position to one that is increasingly managerial.
In any case, the regulatory changes and technical advances are impacting the laboratory landscape, including at the top.
Under CLIA regulations, lab directors for high-complexity laboratories can be either MDs or PhDs with a doctoral degree in a chemical, physical, biological, or clinical laboratory science. (Individuals without either of these backgrounds may also qualify provided they were a lab director or could have qualified as one under regulations as they existed prior to 1992.)
Carlo Ledesma, director of phlebotomy and medical lab technology at Rose State College in Midwest City, Oklahoma, noted that he has seen an increase in lab directors with PhDs as opposed to MDs as the technical complexity of testing platforms has increased in recent years.
"I see that there are more PhDs coming in, especially now that we are moving into a lot of molecular testing, whether in microbiology or chemistry," he said. "There is a lot more drive into molecular and genomic medicine, and understandably, the [PhDs] know more about these types of platforms, the nuts and bolts of them, compared to the medical doctor."
He suggested that this is a trend that could accelerate as reimbursement changes under the Protecting Access to Medicare Act (PAMA) drive labs to adopt more advanced technologies. For instance, under PAMA, many molecular tests are reimbursed at higher rates than conventional tests, which could lead to increased adoption. At the same time, tools like mass spectrometry have the potential to increase test throughput and margins, which could incentivize labs to bring them aboard.
Ledesma said, however, that a PhD lab director's presumed technical expertise could come with trade-offs — specifically in terms of medical expertise.
"Say, for example, a test result is being questioned by a patient's doctor," he said. "That would have to go through the lab director. And I think it would be more beneficial to get a medical opinion [on the validity of the test result] from a medical doctor than from a clinical scientist."
While the CLIAC recommendations don't tackle this issue directly, they do address questions that Hilborne said have arisen over whether the current requirements are sufficient as written to ensure directors have the necessary medical and clinical background.
For instance, while the regulations as written allow for doctorates in "physical sciences" to meet the requirement for lab director training, the CLAIC group suggested in its recommendations that this is "too broad and may not include relevant laboratory science coursework."
"If you have, for instance, a geology degree… you wouldn't qualify by virtue of that degree," Hilborne said.
The group also recommended that references in the regulations to required laboratory experience be modified to specify that this must be "clinical" laboratory experience, as opposed to experience in a non-clinical setting.
"For example, if you had a year of research laboratory experience and you were doing work with animals, well, that's not clinical laboratory experience," Hilborne said.
Like Ledesma, Nader Rifai, director of clinical chemistry at Boston Children's Hospital and editor-in-chief of Clinical Chemistry, observed that PhD-trained lab directors tend to be more prevalent in lab disciplines where newer technologies have a large presence, while MDs typically bring more medical knowledge to the job.
"When we get PhDs we try to spend more time teaching them the pathophysiology, and when we get MDs we spend more time exposing them to the technology," he said.
"[PhDs] tend to play a prominent role in clinical chemistry and microbiology but have very little presence in [areas like] transfusion medicine and hematology," he said. "The reason there are a lot of PhDs in [clinical chemistry and microbiology] is that those sections of the labs are driven in a very large part by new technologies."
Rifai noted that for newer areas like molecular diagnostics, "there is still a battle between MDs and PhDs over who wants to capture that particular segment."
"I would say it is probably almost 50-50, and there are roles to play for both disciplines," he said.
He added that the ongoing revolution in microbiology, which has seen the introduction of tools like nucleic acid-based testing and MALDI-TOF mass spectrometry "caught a lot of traditional microbiologists off guard, because they are not trained on these technologies."
"It will be interesting to see how that evolves over the next 10 years or so, but clearly microbiology as a field is going through what chemistry went through in the 1960s with the introduction of automation and immunoassays," Rifai said.
He said that another change he had observed was the amount of training required around development and validation of laboratory-developed tests given the increased scrutiny such assays currently receive.
"It's not like before where you develop an assay and you use it," he said. "Now, you have to validate it in a very similar way, with very similar data, to what is required by the [US Food and Drug Administration]. A big part of training is [teaching] the entire process for implementing a laboratory-developed test."
Of greatest significance to Rifai, however, is what he said is an ongoing shift in lab director positions away from academic research due to increased regulatory responsibilities and decreasing staffing levels.
"I have been practicing at the director level since 1988, and the practice of the profession has changed so dramatically," he said. "Between the amount of administrative responsibilities and regulatory requirements, there is no time left for any meaningful research."
This isn't just an abstract concern, Rifai said, noting that many of the tests in clinical use today were developed by academic clinical chemists. He cited as examples many commonly used tumor markers along with tests like troponin and b-natriuretic peptide and the notion of genetic testing using cell-free DNA.
"These tests were refined by industry, but they came out of academia," Rifai said, noting that staffing limitations have made it more difficult for academic lab directors to pursue such efforts today.
"The clinical service load is being carried by fewer people, so the opportunity to be highly specialized in a particular area is gone and you have less time to do independent research," he said.
Rifai added that his experience as editor of Clinical Chemistry reinforced this observation.
"I look at where the articles are coming from, and the last time I looked, only 30 percent of the articles we publish have any [authors] associated with a department of laboratory medicine or pathology," he said.