A group of four laboratorians

At the same time that the COVID-19 pandemic has put a bright spotlight on diagnostic testing, labs are struggling in ways frequently invisible to the public. They have been dealing with not only a persistent shortage of supplies during the public health emergency but also a long-standing workforce issue: lack of a sufficient number of highly qualified clinical laboratory scientists.

As healthcare organizations search for answers, AACC is making the case that stronger support of clinical laboratories and a focus on high standards must be part of the solution—pushing back against plans to undercut the financial and professional bedrock that’s enabled laboratories to respond so quickly to the pandemic.

For one thing, the solution shouldn’t be to substitute other healthcare professionals, like nurses, for laboratory roles; instead, more funding for lab training programs are needed, according to the association. Lab training also needs to be adapted to pandemic conditions, when students might not be able to get practical experience.

A new AACC policy report on the scope of practice for laboratory directors describes for policymakers, healthcare administrators, and the public the qualifications and responsibilities of PhD medical laboratory directors. AACC incorporated this document into a position statement, Modernization of CLIA: Moderate and High Complexity Testing.

“My mom doesn’t always know what I do, even though I tell her. Clinical labs tend to be a bit of a black hole,” said Deborah French, PhD, DABCC, FADLM, associate clinical professor, assistant director of chemistry, and director of mass spectrometry at the University of California San Francisco departments of pathology and laboratory medicine. However, during the pandemic, “labs came to the front of everybody’s minds. It’s helped people become more aware that people do this stuff every day.”

French emphasized that it’s crucial for the healthcare field overall to have a clearer picture of what clinical laboratories do, and who medical laboratory directors are, so that the right people are in place. “You can’t just put any old person in charge of a lab,” French said.

The two complementary AACC reports both solidify the role of laboratory director and push for funding to train more medical laboratory scientists to meet increasingly important—and complex—laboratory needs (See Box).

Labs Are Evolving; Regulations Have Not

Clinical laboratories are fundamentally changing. They are using automation to take over repetitive, manual tasks, while also tackling higher volumes—and more complex tests, like those that involve molecular pathology and mass spectrometry.

Janice Conway-Klaassen, PhD, associate professor and program director of Medical Laboratory Sciences at the University of Minnesota, graduated in 1974 with a B.S. in medical technology. “Things have changed every year. This is just another evolutionary step in the role of laboratories,” she said. Especially now. When her lab switched from ICD-9 to ICD-10 billing codes a few years ago, “we went from 8,000 codes to almost 70,000 codes.”

The number of testing sites has also increased in the U.S., from 154,000 in 1993 to 266,000 in 2020. These facilities perform nearly 13 billion tests per year. Advances in technology have also improved the portability of devices, so that tests now can be performed routinely at patients’ bedsides, in ambulances, mobile clinics, doctors’ offices, and sometimes even in patients’ homes. Drive-through testing became the norm during the COVID-19 pandemic.

At the same time, rules governing patient testing have remained largely unchanged since 1995 and haven’t adapted to the way tests are run now. For these reasons, AACC’s CLIA position statement pushes for more funding to train clinical laboratory scientists to meet testing demand.

“Results have to be accurate, and who better to do these procedures, operate these instruments, interpret the results, and consult with doctors than people who have been trained to do that,” said David Koch, PhD, DABCC, FADLM, professor of pathology and co-director of the postdoctoral training program in clinical chemistry at Emory University in Atlanta. Koch is a past AACC president and former chair of the AACC Policy and External Affairs Committee. “The assumption that laboratory testing is an easy matter and anybody can do it is not true,” he stressed.

Misunderstood Roles

In a way, the COVID-19 pandemic has boosted the visibility of clinical laboratories, and the constant conversations about and demand for testing have highlighted their crucial role in healthcare delivery. That doesn’t mean the instruments that perform those tests—or the qualifications of the people who oversee labs—is well understood.

In 2018, the Centers for Medicare and Medicaid Services floated the idea of nurses performing clinical laboratory tests. While that notion was soundly refuted by AACC and other laboratory advocacy groups, the concept still hasn’t gone entirely away.

“Even if you take out of the equation that their training does not involve things like quality control, they’re not trained to do what we do,” French said. Just as no one would expect laboratory scientists to start doing routine nursing tasks, like taking patients’ vital signs, nurses shouldn’t be expected to know how to run tests. “If you are suggesting that nurses become lab people, you’re taking them away from doing important patient care,” she said.

In working on these position statements, Koch said he talked to dozens of nurses, and when he mentioned the idea of nurses taking over lab testing duties, the general response was, “That’s ridiculous; we’re busy all the time,” he said.

Leadership of labs needed to be defined, too. In the new scope of practice statement about board-certified PhD medical laboratory directors, AACC clearly states what these professionals do, their necessary education and experience requirements, and their responsibilities and core competencies.

“The goal is that medical laboratory directors have the right training, skills, understanding, and responsibility, and fulfill those responsibilities on a daily basis,” Koch said. “It’s important because every patient result is important.”

Koch added that AACC’s practice statement perhaps marks the first time in the clinical laboratory profession that the role has been so defined. “There’s been a hodgepodge of different documents, but it was never put together in one document like we’ve done,” he said.

Short Staffing

The pandemic has also punched a few holes in clinical laboratory training this year. With many hospitals closing labs or imposing strict limits on who was allowed inside, students lost critical opportunities for hands-on training that usually make up the last semester of their education, said Conway-Klaassen.

“Our program was lucky in that we were able to do an adaptive clinical simulation,” she said. Still, students didn’t do the typical work in real-life situations using actual instruments and facing a real testing load. “It’s been a struggle for programs to finish. Many of us have adapted, but it’s not perfect,” said Conway-Klaassen.

Her program worked with its clinical laboratory partners to discuss what to do and what training would be acceptable to them. The program ended up graduating students even though they weren’t able to complete their capstone clinical training. Laboratories were willing to “accept these students knowing they may need to do additional training,” she said.

All of University of Minnesota’s medical laboratory science spring students graduated with jobs, though more than typical have part-time versus full-time jobs. Many labs are still closed, or under hiring freezes, so that while the program would prefer all students to have full-time jobs, “that they’re employed is huge,” said Conway-Klaassen.

She also said a number of students took deferrals this year. Some are living with elderly parents or grandparents and didn’t want to risk being exposed to SARS-CoV-2 and bringing it home. Others lost access to childcare or are staying home with their children doing remote learning.

“We’re trying to approach these situations with compassion and treat people with kindness and understanding of the stress we’re all under. We’re all feeling it in all directions,” said Conway-Klaassen.

A bright spot: Even if laboratories are not able to take students on-site, they can help in other ways during the pandemic, Conway-Klaassen said. Already her network of training sites has stepped up to teach and find other means to help students develop. “One of the ways some of the sites helped was by participating in the clinical simulation we did on campus as guest lecturers,” she noted. “They also provided virtual tours of their laboratory facilities. One of them even provided a video of the medical laboratory scientist staff members performing instrument maintenance.”

Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey.

twitter: @byJenAMiller