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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

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Forbes Senior Contributor Covers Reasons for Growing Staff Shortages at Medical Laboratories and Possible Solutions

Factors contributing to shortage of med techs and other lab scientists include limited training programs in clinical laboratory science, pay disparity, and staff retention, notes infectious disease specialist Judy Stone, MD

Staff shortages are a growing challenge for medical laboratories, and now the problem has grabbed the attention of a major media outlet.

In a story she penned for Forbes, titled, “We’re Facing a Critical Shortage of Medical Laboratory Professionals,” senior contributor and infectious disease specialist Judy Stone, MD, wrote, “Behind the scenes at every hospital are indispensable medical laboratory professionals. They performed an estimated 13 billion laboratory tests in the United States each year before COVID. Since the pandemic began, they have also conducted almost 997 million diagnostic tests for COVID-19. The accuracy and timeliness of lab tests are critically important, as they shape approximately two-thirds of all medical decisions made by physicians.”

Stone was citing data from the US Bureau of Labor Statistics.

Though Stone states in her Forbes article that clinical laboratories in both the US and Canada are facing staff shortages, she notes that the problem is more acute in the US.

As Dark Daily reported in February, the so-called “Great Resignation” caused by the COVID-19 pandemic has had a severe impact on clinical laboratory staffs, creating shortages of pathologists as well as of medical technologists, medical laboratory technicians, and other lab scientists who are vital to the nation’s network of clinical laboratories.

In her analysis, however, Stone accurately observes that the problem pre-dates the pandemic. For examples she cites two surveys conducted in 2018 by the American Society for Clinical Pathology (ASCP):

Many pathologists and clinical laboratory managers would agree that Stone is right. Dark Daily has repeatedly reported on growing staff shortages at clinical laboratories worldwide.

In “Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP,” Dark Daily reported on presentations given during the 2021 College of American Pathologists (CAP) virtual meeting in which presenters discussed the ever-increasing demand for COVID-19 testing that had placed an enormous amount of stress on clinical laboratories, medical technologists (MTs), and clinical laboratory scientists (CLSs) responsible for processing the high volume of SARS-CoV-2 tests, and on the supply chains medical laboratories depend on to receive and maintain adequate supplies of testing materials.

And in “Lab Staffing Shortages Reaching Dire Levels,” Dark Daily’s sister publication, The Dark Report, noted that CAP Today had characterized the current lab staffing shortage as going “from simmer to rolling boil” and that demand for medical technologists and other certified laboratory scientists far exceeds the supply. Consequently, many labs now use overtime and temp workers to handle daily testing, a strategy that has led to staff burnout and more turnover.

Judy Stone, MD
“There is a critical shortage of medical laboratory professionals in the US, and in Canada to a lesser extent,” wrote infectious disease specialist Judy Stone, MD (above), in an article she penned for Forbes. “Here [in the US],” she added, “we are 20-25,000 short on staff, with only 337,800 practicing. That is roughly one medical laboratory scientist per 1,000 people.” Clinical laboratories are well aware of the problem. A solution to solve it and return labs to former staffing levels is proving elusive. (Photo copyright: Forbes.)

Why the Shortfall?

In her Forbes article, Stone notes the following as factors behind the shortages:

  • Decline in training programs. “There are only [approximately] 240 medical laboratory technician and scientist training programs in the US, a 7% drop from 2000,” Stone wrote, adding that some states have no training programs at all. She notes that lab technicians must have a two-year associate degree while it takes an average of five years of post-secondary education to obtain a lab science degree.
  • Pay disparities. Citing data from the ASCP, Stone wrote that “medical lab professionals are paid 40%-60% less than nurses, physical therapists, or pharmacists.” Moreover, given the high cost of training, “many don’t feel the salary is worth the high investment,” she added.
  • Staff retention. In the ASCP’s 2018 job satisfaction survey, 85.3% of respondents reported burnout from their jobs, 36.5% cited problems with inadequate staffing, and nearly that many complained that workloads were too high.
  • Inconsistent licensing requirements. These requirements “are different from state to state,” Stone wrote. For example, the American Society for Clinical Laboratory Science (ASCLS) notes that 11 states plus Puerto Rico mandate licensure of laboratory personnel whereas others do not. Each of those states has specific licensing requirements, and while most offer reciprocity for other state licenses, “California [for example] does not recognize any certification or any other state license.”

In a 2018 report, “Addressing the Clinical Laboratory Workforce Shortage,” the ASCLS cited other factors contributing to the shortages, including retirement of aging personnel and increased demand for lab services.

Possible Solutions

Stone suggested the following remedies:

  • Improve working conditions. “We need to reduce the stress and workload of the lab professionals before we reach a greater crisis,” Stone wrote.
  • Standardize state certification. This will facilitate “mobility of staff and flexibility in responding to needs,” Stone suggested.
  • Improve education and training opportunities. The ASCLS has called for clinical lab science to be included in the Title VII health professions program, which provides funding for healthcare training. Rodney Rohde, PhD, a clinical laboratory science professor at Texas State University, “also suggests outreach to middle and high school STEM programs, to familiarize students early with career opportunities in the medical laboratory profession,” Stone wrote.
  • Recruit foreign workers. Stone suggested this as an interim solution, with programs to help them acclimate to practice standards in the US.

It will likely take multiple solutions like these to address the Great Resignation and bring the nation’s clinical laboratory staffing levels back to full. In the meantime, across the nation, a majority of clinical laboratories and anatomic pathology groups operate short-staffed and use overtime and temporary workers as a partial answer to their staffing requirements.

Stephen Beale

Related Information:

We’re Facing a Critical Shortage of Medical Laboratory Professionals

Our Lab Testing Capacity Is Getting Dangerously Low

Addressing the Clinical Laboratory Workforce Shortage

What You Need to Know about Working as a Lab Professional in a Different State

The American Society for Clinical Pathology’s Job Satisfaction, Well-Being, and Burnout Survey of Laboratory Professionals

The American Society for Clinical Pathology’s 2018 Vacancy Survey of Medical Laboratories in the United States

Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP

Lab Staffing Shortages Reaching Dire Levels

In Today’s Tough Labor Market, Smart Clinical Labs Are Using Social Media, LinkedIn, to Recruit and Retain Top-Performing Med Techs and Young Pathologists

It’s not limited to recruiting; social media and LinkedIn are just as effective at helping lab managers advance their personal careers by helping them find their ideal jobs

It’s the toughest labor market in decades for skilled clinical laboratory and pathology professionals! In cities across America, lab managers struggle, not only to recruit and fill open positions, but also to retain their most-skilled staff members who are getting first-rate offers from competing labs.

How tight is the job market in pathology? Just ask the young pathologists who’ve graduated from their residency programs and fellowships. In recent years, it’s become tougher and tougher to find a position in a city of their preference that fits their subspecialty training. (more…)

New Point of Care Test for Anemia That Patients Can Administer Themselves Has Potential to Impact Pathology Groups and Clinical Laboratories

Developed by researchers at Emory University, Children’s Healthcare of Atlanta, and the Georgia Institute of Technology, the anemia test device is awaiting clearance by the FDA

New diagnostic technology may shift some hemoglobin testing for anemia out of clinical laboratories and into near-patient settings. It may also be possible to use this new diagnostic device for patient self-testing.

The developers describe this as a new, easy, inexpensive point-of-care test (POCT) that detects anemia. The device may be available as early as 2016. It is possible for the test to be used in situations where resources are low and illiteracy is high.

The new medical laboratory test is called AnemoCheck and was developed by scientists and students at Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology in Atlanta. (more…)

Studies Show How Clinical Whole-Exome Sequencing May Forever Change the Future Practice of Medicine while Giving Pathologists a New Opportunity to Deliver Value

Similar study of exome sequencing at UCLA produces findings that mirror the diagnostic outcomes produced by researchers at the three Houston organizations

In recent years, pathologists and other clinical laboratory professionals have seen increasing evidence of the benefits of using exome sequencing for clinical diagnostic purposes.

Confirming their initial published findings of a 25% molecular diagnostic rate, researchers from Baylor College of Medicine (BCM), Baylor Human Genome Center, and the University of Texas Health Science Center at Houston have released results of a large sampling of 2,000 consecutive patients.

In this expanded study, published in the November 12, 2014, issue of the Journal of the American Medical Association (JAMA), 504 patients (25.2%) received a molecular diagnosis and 92 patients (4.6%) benefitted from medical intervention to ameliorate or eliminate negative symptoms. (more…)

Pathologists and Researchers Predict Development Trajectory for Biomarker-based Molecular Diagnostics in Support of Translational Medicine

Emerging field of translational medicine expected to contribute to more informative studies that provide superior data for making medical decisions

These are boom times for translational medicine. That’s the term used to describe how the health of individuals and the community can be improved through applying new knowledge into diagnostic tools (including medical laboratory tests), medicines, procedures, policies, and education.

Rapid developments in the field of translational medicine include a role for pathologists who are discovering and validating molecular biomarkers associated with diseases.

Pathologists Have a Role in the Science of Translational Medicine

Translational medicine was the centerpiece in an interview conducted with an expert in biomedical research. Translational medicine is “where unproven observations advance to increasingly large and more informative studies to provide definitive and comparative information for a medical decision in routine clinical practice” contended Biomedical Consultant John Sninsky, Ph.D., former Vice President of Discovery Research at Alameda, California-based Celera Diagnostics. He was quoted in an interview published by GenomeWeb.

In validating translational medicine findings, Sninsky noted that everyone (e.g. pathologists, clinical laboratory scientists, and medical technologists) who contribute to the process must “weigh and balance” information so that it’s not used prematurely, but also not delayed when it has been proven useful to medical decisions. “So, in the end, no one piece of information, whether it be the conventional diagnostic test or the new test, will suffice for medical decisions, but will require gathering and reflecting on as much of the information as possible,” added Sninsky.

Large-scale Studies Better Sources for Personalized Medical Data

The goal of “personalized medicine” is for doctors to be able to prescribe treatments that more effectively “target” their patients’ unique physiologies and conditions. How to best conduct research and interpret the findings in ways that advance clinical care is under debate, as experts address the issues of individualized care versus population management.

What makes translational medicine relevant to pathologists, clinical chemists, and other clinical laboratory scientists is that this field of science is already changing how research studies and clinical trials are designed and conducted. Experts knowledgeable in this field predict that the principles of translational medicine will support important improvements.

First, these methods will be used to design clinical studies that are less expensive and faster to complete. Second, when such studies are conducted in this fashion, there will be a faster timeline between publication of findings and acceptance by providers, payers, and patients. Both improvements have the potential to directly benefit clinical labs as they develop new medical laboratory tests, conduct the clinical studies needed to demonstrate patient benefits, and then clear regulatory requirements needed to bring these new diagnostic assays to market.

The best method for gathering that data, however, is in question, noted Sninsky. He thinks large-scale studies are a better source for accumulating the needed data than research on individuals. “If you identify personalized medicine as information that’s truly unique to an individual, we actually think that information applicable to segments of the population will prove more timely and more important,” stated Sninsky, who then added, “we think that maybe calling it ‘targeted medicine’ rather than personalized medicine makes the case in point.”

Biomedical Consultant John Sninsky, Ph.D

Biomedical Consultant John Sninsky, Ph.D. (pictured above), former Vice President of Discovery Research at Alameda, California-based Celera Diagnostics, said in an interview with GenomeWeb that Targeted Medicine is more descriptive of where disease management is heading, rather than Personalized Medicine, because gathering information on a segment of the population is more straight forward than gathering information on an individual. (Photo copyright Celera Diagnostics)

Sninsky pointed out that validation and demonstration of utility only comes with replication in large studies. Therefore, in order to be effective, he suggested that applicable information would usually address about 10% of the population, “so disease management or health management, in the context of targeted medicine, is the way we think about it.”

Role of Clinical Laboratories in the Accelerated Development of In Vitro Diagnostic Assays

According to Sninsky, the natural progression and availability of diagnostics won’t change much. Large clinical reference laboratories will continue to create laboratory-developed assays. These “home-brews” will then evolve into FDA-approved in vitro diagnostic products that get distributed to “lower-throughput” clinical laboratories.

Sninsky further observed that sometimes these “smaller service laboratories” end up offering the assays as a [clinical] service after they’re launched. This accelerates the assay’s development as an in vitro product, he said, noting that the advantage of in vitro diagnostic products over services is their widespread availability.

NIH Support for Translational Medicine Steps Up FDA Regulatory Process

Sninsky acknowledged that getting biomarker-based molecular diagnostics validated and cleared through the Food and Drug Administration (FDA) and into the hands of physicians continues to be an onerous process. The FDA, however, has taken steps to accelerate the process, which Sninsky welcomes.

“One of the things I think is really good news is the stand that the U.S. regulatory agency has taken in terms of saying we’re going to help this process along,” he noted. “If someone would have said to me 15 years ago that the FDA was going to be leading the charge of the application of biomarkers, I would have been pessimistic about that.”

Since launching its Experiential Learning Program (ELP), the FDA’s Center for Devices and Radiological Health (CDRH) has accelerated the pre-market approval rate of medical and diagnostic devices, which includes in vitro diagnostic products.

Support for advancing the translational medicine approval process was demonstrated by the National Institutes of Health (NIH) in 2011 with the establishment of the National Center for Advancing Translational Sciences (NCATS). NIH also recently launched a Precision Medicine Initiative that aims to use genetic data from individuals to personalize diagnostic and therapeutic strategies. This $215 million project is pending Congressional approval of the President’s 2016 budget. (See Dark Daily, “Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?”, March 23, 2015.)

Clinical Laboratories Provide the Diagnostic Tests for Physicians

While the clinical laboratories that run these tests do help in the development and wider distribution of in vitro diagnostic assays, Sninsky believes that caregivers, health plans, and patients have a greater role in demonstrating clinical effectiveness. “What our experience has been is it’s not the clinical labs who will decide whether new biomarkers are used, but instead will be the practicing clinicians, the reimbursement agencies, and the patients who see value in them that will make those decisions,” concluded Sninsky.

–Patricia Kirk

Related Information:

‘Targeted Medicine’: New Name of the Game 

Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services? 

Weill Cornell and New York Presbyterian to Create New Precision Medicine Institute to Use Genome Sequencing to Individualize Cancer Treatment 

FDA Pushes Forward with Plans to Regulate Laboratory-Developed Tests, in a Move that Will Impact Many Clinical Laboratory Companies and Pathology Groups 

FDA Approving Devices Faster 

FDA Presents Plans to Ensure the Reliability of Laboratory-Developed Diagnostic Tests 

NIH and FDA Join Forces to Advance Translational Medicine and Regulatory Science 

FDA Expands Its Internal Program to Learn More from Companies about Medical Device Manufacturing 

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