New AI tool doubled efficiency in busy university radiology department
Creative artificial intelligence (AI) solutions are being developed to address critical staffing shortages in radiology that could help with similar shortages in overworked pathology and clinical laboratories as well.
In a recent clinical study at 11-hospital Northwestern Medicine, researchers developed a new generative AI radiology tool to assist radiologists that demonstrates high accuracy and efficiency rates when working with multiple types of imaging scans.
For the study, approximately 24,000 radiology reports were analyzed and then compared for clinical accuracy with and without the AI tool. The tool evaluates an entire scan and generates a report that is 95% complete and personalized to each patient. A template based on that report is then provided to radiologists for review, according to a Northwestern Medicine Feinberg School of Medicine news release.
The study reported an average 15.5% increase in radiograph efficiency without compromising accuracy. Some radiologists even produced gains as high as 40%. The radiology reports were scrutinized during a five-month period last year and enabled radiologists to improve the time it took to return a diagnosis.
“This is, to my knowledge, the first use of AI that demonstrably improves productivity, especially in healthcare. Even in other fields, I haven’t seen anything close to a 40% boost,” said the study’s senior author Mozziyar Etemadi, MD, PhD, assistant professor of anesthesiology and biomedical engineering at Northwestern University McCormick School of Engineering, in the news release. (Photo copyright: Northwestern University.)
Doubled Efficiency for One Radiology Team
“For me and my colleagues, it’s not an exaggeration to say that it doubled our efficiency. It’s such a tremendous advantage and force multiplier,” said study co-author Samir Abboud, MD, emergency radiology in the department of radiology at Northwestern Medicine, in the news release.
“Having a draft report available, even before it is viewed by the radiologist, offers a simple, actionable datapoint that can be quickly and efficiently acted upon” added study senior author Mozziyar Etemadi, MD, PhD, assistant professor of anesthesiology and biomedical engineering at Northwestern University McCormick School of Engineering, in the news release. “This is completely different than traditional triage systems, which need to meticulously be trained one by one on each and every diagnosis.”
The AI tool can also alert radiologists to life-threatening conditions.
“On any given day in the ER, we might have 100 images to review, and we don’t know which one holds a diagnosis that could save a life,” Abboud said. “This technology helps us triage faster—so we catch the most urgent cases sooner and get patients to treatment quicker.”
Relying on In-house Data
Engineers at Northwestern developed the AI model using clinical data within the university’s own network, emphasizing that such tools can be created without assistance from other organizations.
“Our study shows that building custom AI models is well within reach of a typical health system, without reliance on expensive and opaque third-party tools like ChatGPT,” Etemadi noted.
The Journal of the American College of Radiology states the supply of radiologists is expected to increase by approximately 26% over the next 30 years. However, the need for radiologists is expected to grow between 17% and 27% over the same period. Becker’s Hospital Review reports there will be a shortage of up to 42,000 radiologists in the US by 2033.
Some health organizations are using a mixed model of permanent employees and contracted radiologists to meet the increasing demand for services. Others are also looking at options such as internal training programs, better benefits for workers, teleradiology, and remote radiologists to fulfill radiology needs.
“You still need a radiologist as the gold standard,” Abboud said. “Medicine changes constantly—new drugs, new devices, new diagnoses—and we have to make sure the AI keeps up. Our role becomes ensuring every interpretation is right for the patient.”
Can pathology practices and clinical laboratories learn from radiology’s situation? Development of AI solutions for those fields would likely have similar effects on workloads and overworked personnel.
Exploring the benefits of AI may be one way of helping meet clinical laboratory and pathology practice staff shortages.
Some of the former employees worked for public health labs involved in tracking HIV, hepatitis, and STDs
More than 450 federal employees who were laid off from the Centers for Disease Control and Prevention (CDC) during the April cutbacks are being reinstated by the Department of Health and Human Services (HHS).
Nearly half (214) worked for the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention (NCHHSTP), which includes specialized public health laboratories. Another 158 worked at the National Center for Environmental Health (NCEH). Others were employed by the Immediate Office of the Director and Global Health Center.
“I think people are very tacitly hopeful that this means they can get their jobs back and continue serving in ways that they love,” NCEH health scientist Kathryn Sisler, MPH, told NPR. “But there has been so much instability and chaos that I think a lot of people would hesitate to say it is good news.”
Sisler, who works in NCEH’s Division of Environmental Health Science and Practice, received an email notification of her reinstatement on June 11, NPR reported.
She described the rehiring as “a step in the right direction,” but noted that she was among some employees in her division who had moved away from Atlanta, where the CDC is based. “Other employees had taken other jobs or had been offered them,” NPR reported.
In an interview with NPR, Scott Becker, CEO of the Association of Public Health Laboratories, admitted to being “happily flabbergasted” to hear about HHS’ offer to rehire the former federal workers. (Photo copyright: Association of Public Health Laboratories.)
Impact at Critical Labs
As part of the cutbacks, the CDC shut down two laboratories at NCHHSTP that were involved in tracking viral hepatitis and sexually transmitted diseases, even as “some of those scientists performed disease surveillance work unlike any other labs in the world,” NPR noted.
NCHHSTP staffers told NPR that some of the division’s labs were damaged due to the “lapse in activity” during April and May, and that “some disease outbreaks had not been properly tracked.” One employee said that, due to the cutbacks, the division’s hepatitis lab was unable to assist health workers tracking a hepatitis C outbreak in Florida. The CDC employees requested anonymity.
“It’s great to see that there is some recognition of the importance of these workers and that being in those positions is critical for the public health of America and that they are being reinstated in order to continue their important work,” Carmen J. Marsit, PhD, of Emory University’s Rollins School of Public Health, told NPR. He added, however, that “there’s still a lot of people that are not being reinstated.”
HIV Not Being Tracked
KFF Health News reported that the reinstatements included “dozens of HIV experts” who were laid off in April. At the time, they were working on a national survey conducted among 30,000 individuals at risk of acquiring the infection. They haven’t been told if the project will resume.
Public health departments use data from the survey as part of their efforts to reduce spread of the disease, KFF Health News stated, noting that “preventing HIV is far cheaper than treating people once they’re infected.”
Since the cutbacks, many HIV researchers at CDC have obtained new jobs or moved. Some employees “called the reinstatements perplexing because the notices don’t say what they’ll be doing when they return and for how long,” KFF Health News reported.
“I am concerned about how many of the people have already moved on or might move on and the trauma that they really must be going through with the uncertainty,” Scott Becker, CEO of the Association of Public Health Laboratories, told NPR about the reinstatements at CDC. “But all in all, it’s good news and I’ll take it.”
Programs Cut by Mistake
The reinstatements amount to approximately 20% of the 2,400 CDC employees laid off following the March 27 announcement of a massive restructuring at HHS.
HHS secretary Robert F. Kennedy, Jr. told ABC News in early April that some programs had been cut by mistake. “Personnel that should not have been cut were cut—we’re reinstating them, and that was always the plan,” he said.
In May, Kennedy said that 328 employees of the CDC’s National Institute for Occupational Safety and Health (NIOSH) would be reinstated, NPR reported, following “considerable pushback from labor organizations and congressional lawmakers.”
NPR and other outlets had earlier reported that HHS planned to cut at least 900 NIOSH employees, amounting to 90% of the institute’s workforce.
Industry commenters point to a void since the federal government shuttered the Clinical Laboratory Improvement Advisory Committee
For readers wondering what has happened to the Clinical Laboratory Improvement Advisory Committee (CLIAC), the bottom line is the panel has been terminated, causing a significant void for the lab industry at the federal level.
Dark Daily’s sibling brands, including The Dark Report, G2 Intelligence, and Today’s Clinical Lab, have been exploring various aspects about the demise of CLIAC.
The Centers for Disease Control and Prevention (CDC) confirmed to G2 Intelligence that CLIAC was terminated as of March 31, citing an executive order from President Donald Trump intended to reduce federal advisory committees. The decision blindsided even those closest to CLIAC. Incoming committee chairman Jordan Laser, MD, revealed in an email to colleagues that he did not have more insight into CLIAC’s demise beyond media reports, G2 reported.
Since its founding in 1992, CLIAC has played an influential—though non-regulatory—role in shaping updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The committee brought together pathologists, lab directors, public health leaders, and representatives from federal agencies such as the CDC, Centers for Medicare and Medicaid Services, and Food and Drug Administration.
The federal government’s decision to eliminate CLIAC “risks stalling progress in laboratory medicine, which could ultimately hinder efforts to improve patient care,” CAP President Donald Karcher, MD, FCAP, told The Dark Report. (Photo copyright: College of American Pathologists.)
‘Critical Venue’ for Labs Has Been Eliminated
Industry groups are sounding alarms about what comes next. In an interview with Today’s Clinical Lab, Anthony Killeen, MD, PhD, president of the Association for Diagnostics and Laboratory Medicine (ADLM), said CLIAC was an important forum for medical lab scientists to discuss CLIA.
“[CLIAC] served as a critical venue for working through current problems with the rule and also for expert input on how new technologies—such as next-generation sequencing, digital pathology, and artificial intelligence-assisted diagnostics—should be assessed and integrated under CLIA,” Killeen said.
ADLM has formally urged Department of Health and Human Services Secretary Robert F. Kennedy, Jr. to reverse the CLIAC decision. In a May letter, the association emphasized that CLIAC’s work was funded entirely through user fees paid by clinical laboratories rather than taxpayer dollars—a point many in the lab industry say underscores CLIAC’s value.
CAP President Wonders about Future Communication Gaps
The Dark Report noted that the disbanding of CLIAC may cost labs time in certain cases, a commodity that few diagnostic settings have in abundance.
“The absence of this advisory body may lead to gaps in communication and slower response times in addressing [industry] challenges,” Donald Karcher, MD, FCAP, president of the College of American Pathologists (CAP), told The Dark Report.
The absence of CLIAC raises uncertainty for clinical labs because federal agencies have lost a prime source to gather specialized input on complex scientific and operational issues facing the lab industry. Dark Daily’s partner brands will continue to track this matter closely. If you’re not a subscriber, you can check out The Dark Report’s insider coverage with a 14-day free trial.
Pharmaceutical and biotech researchers convened last week to discuss their latest work on targeting neurodegenerative diseases
With all the news this year alone on progress being made with diagnostic testing for Alzheimer’s disease, clinical laboratory professionals will be interested to know that drug discovery efforts to combat neurogenerative diseases are also at a heightened pitch.
Last week at the one-day Neuroimmunology in Drug Discovery forum in Boston, scientists learned about the latest advances in therapeutic research to better treat Alzheimer’s disease, multiple sclerosis, and Parkinson’s disease. As the treatments advance, demand for them will increase, which goes hand-in-hand with medical lab testing to detect signs of these illnesses.
The concern is urgent. The US Food and Drug Administration (FDA) noted that 10% of people age 65 and older have Alzheimer’s disease, and that number could double by 2050. The FDA recently cleared the first in vitro diagnostics device that tests blood to diagnose Alzheimer’s, and other IVD manufacturers and clinical labs are working on other Alzheimer’s tests, Dark Daily reported.
“It’s looking quite promising for NLRP3 inhibitors,” said Cheryl Leyns, PhD, associate principal scientist in discovery neuroscience at Merck Research Laboratories, in discussing how mutations of the NLRP3 protein can lead to neurodegenerative diseases. (Photo copyright: ELRIG.)
Much of the discussion at the Neuroimmunology in Drug Discovery forum centered on the idea that neuroinflammation—in other words, inflammation of the brain or spinal cord—starts well before neurodegenerative diseases arise. Neuroinflammation can accelerate Parkinson’s disease and other neurodegenerative disorders, said Cheryl Leyns, PhD, associate principal scientist, neuroimmunology, at Merck Research Laboratories in Boston, who spoke at the event.
From that perspective, drug discovery researchers are on the prowl for these early signs of future problems.
Leyns discussed NLRP3, a protein that aids the body’s inflammation process. A mutation of NLRP3 can lead to inflammatory problems, making the protein a prime target for researchers. “We have been interested, in the biopharma space, in the potential of NLRP3 inhibitors,” she noted.
Older Immune Systems Are Susceptible
While many in the public correctly associate Alzheimer’s with a person being outwardly older, a lesser-known aspect is that the body’s immune system also ages, becoming more susceptible over time to chronic inflammation.
Wailings’ assertion was not rhetorical. She pointed to numbers which showed scholarly research that involved the terms “inflammation,” “neurodegeneration,” and “aging” was only about 17% of the total amount of journal articles that addressed the first two terms, but which did not include “aging.”
As the pharmaceutical, biotech, and medical fields move aggressively forward to defend people against neurodegenerative diseases like Alzheimer’s, clinical laboratory scientists should take comfort that diagnostic testing trends are solidly in the mix.
Therapeutic advances, along with increased options for testing, show promising signs that patients and their caregivers will have more tools to use in the battle against these illnesses.
Clinical laboratories should take a proactive approach to ensure compliance with current price transparency regulations
Price transparency in healthcare continues to be a focus of the Centers for Medicare and Medicaid Services (CMS). As of this ebrief, the agency has cited nearly a dozen hospitals this year that failed to, wholly or in part, follow through with federal legislation due to technical issues.
The citations, paired with President Trump’s executive order from February on price transparency, demonstrates a growing trend toward costly enforcement.
It’s not clear from the documentation posted by CMS if any of this involves price transparency with clinical laboratory tests. Labs that operate within hospitals or health systems are subject to the executive order; thus, diagnostic test pricing estimates are subject to transparency mandates.
Based on enforcement actions posted online by CMS, it’s clear that the agency is looking into technical issues of price transparency requirements that have little to do with diagnostic medicine. From that perspective, clinical laboratory teams may want to pass this Dark Daily ebrief along to their IT department and business analysts, whose work is drawing criticism from CMS at some hospitals.
The entire lab team should be proactive on the issue of price transparency.
“Imagine how a one-on-one conversation with a patient would go if a physician explained that a routine cholesterol test sent to Lab A would cost five times that of Lab B. Anyone think the patient would choose Lab A?” wrote Bryan Vaughn, senior vice president, health systems and mid-America division, Labcorp, in an article he penned for the lab company’s website. (Photo copyright: Labcorp.)
Hefty Fines and Warnings from CMS
According to CMS, already in 2025, 10 hospitals have received civil monetary penalty (CMP) notices of hefty fines for non-compliance. They include:
Arkansas Methodist Medical Center, Paragould, Ark. $309,738
Northlake Behavioral Health System, Mandeville, La. $257,180
Lawrence Rehabilitation Hospital, Brick, N.J. $120,120
Community Care Hospital, New Orleans, La. $93,214
Hill Hospital of Sumter County, York, Ala. $84,216
Bucktail Medical Center, Renovo, Pa. $75,582
D.W. McMillan Memorial Hospital, Brewton, Ala. $71,852
First Surgical Hospital, Bellaire, Texas $62,016
CCM Health, Montevideo, Minn. $55,611
Southeast Regional Medical Center, Kentwood, La. $32,301
Payments for citations are due 60 days after receiving the CMP notice.
Trump’s Executive Order
CMS’ price transparency focus comes alongside President Trump’s Executive Order 14221, “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information,” which the administration put out in February of this year, CMS noted.
As covered in the March 31 issue of The Dark Report, a sister publication to Dark Daily, Trump’s order is an expansion of his previous price transparency ruling, which went into effect at the start of 2021.
At that time, hospitals were required to “provide clear, accessible pricing information online about the items and services they provide” that was easy understand and to use, and machine-readable files listing all services and items available, CMS noted.
Impact on Clinical Laboratories
CMS’ updated requirements and refreshed reinforcement against healthcare organizations remain pertinent to hospital laboratories mostly due to extreme variations in test pricing.
“Reports continue to point out wide differences in the prices of routine laboratory testing across settings. Yet, routine lab testing may be some of the most comparable procedures in healthcare, with minimal differences in methods or quality,” wrote Bryan Vaughn, senior vice president of health systems and the mid-America division at Labcorp, in an article he penned for the lab company’s website.
Vaughn cited as much as a $600 difference found between metabolic or lipid panels and other standard lab tests.
It behooves clinical labs to verify that the information they provide to consumers online about test prices is indeed easy to understand and meets the spirit of the executive order and CMS. Failure to do so could be costly to a health system or hospital.
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test measures blood biomarkers associated with the disease
Clinical laboratories could soon find themselves playing a significant role in Alzheimer’s care as the US Food and Drug Administration (FDA) announced its first-ever clearance of a blood test to assist in diagnosing the cognitive disease.
The agency issued a 510(k) clearance for the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test from Fujirebio Diagnostics, Inc. The test is intended for “the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease,” according to an FDA press release.
“Nearly seven million Americans are living with Alzheimer’s disease, and this number is projected to rise to nearly 13 million,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, MD, PhD, in the press release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease.”
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, MD, MPH, in the FDA press release.
“Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients,” said FDA Commissioner Martin A. Makary, MD, MPH, in the FDA press release. (Photo copyright: Johns Hopkins University.)
Blood Protein Test Details
Fujirebio’s test calculates the ratio of two blood proteins, pTau217 and β-amyloid 1-42. “This ratio is correlated to the presence or absence of amyloid plaques in the patient’s brain, reducing the need for a PET scan,” the press release states.
The FDA said it has already authorized or cleared similar tests that use cerebrospinal fluid (CSF) samples obtained through an invasive spinal tap. “This new Lumipulse test only requires a simple blood draw, making it less invasive and much easier for patients to access,” the FDA said.
In granting the clearance, the agency looked at data from a clinical study of 499 adults displaying signs of cognitive impairment. Close to 92% of participants with positive test results had amyloid plaques as determined by amyloid PET scan or CSF test results. Approximately 97% with negative results from the Lumipulse test were also shown to be negative in the PET scan or CSF test. Fewer than 20% of the patients received indeterminate results, which would require additional testing.
The primary risks of the test are false positive or false negative results, the federal agency noted.
“Importantly, the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is not intended as a screening or stand-alone diagnostic test and other clinical evaluations or additional tests should be used for determining treatment options,” the FDA said.
‘Wild West’ Marketplace
In their reporting of this story,MedPage Today and the Associated Press both noted that some laboratory-developed tests can already measure plasma biomarkers associated with Alzheimer’s.
“But those tests aren’t reviewed by the FDA and generally aren’t covered by insurance,” the AP reported. “Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a ‘wild west.’”
Neurologist Richard S. Isaacson, MD, told CNN that he’s already using the test for research purposes. “It can provide better clarity into whether a person experiencing memory loss may have Alzheimer’s disease,” he said.
However, he cautioned that more research is needed to allow doctors to make best use of the test.
“I think the next step as a field is, we need to advance education about what these tests mean and what they don’t and who they should be used for,” he told CNN. “Because they mean different things in different people depending on their risk factors and whether they have symptoms. So, we’re still early.”
“The results must be interpreted in conjunction with other patient clinical information,” the FDA acknowledged in their press release.
Other Alzheimer’s Tests
The FDA said it reviewed the Lumipulse test through the 510(k) premarket notification pathway, in which the federal agency determines if a device is “substantially equivalent to a legally marketed predicate device.”
In this case, the agency found that the test is substantially equivalent to Fujirebio’s Lumipulse G β-amyloid Ratio (1-42/1-40), which measures the same proteins in CSF samples. The FDA authorized that device in 2022, according to a Fujirebio press release. That test uses Fujirebio’s automated Lumipulse G1200 instrument system.
Other companies including Roche, Eli Lilly, and C2N Diagnostics are also developing Alzheimer’s tests they intend to submit for FDA review, the AP reported.
