This is yet another example that dogs can be highly accurate screeners for disease. But are they ready to be included in clinical laboratory diagnostic tests?
Thailand researchers have trained dogs to screen for COVID-19 infections in humans, despite the country’s “spicy and flavorful cuisine,” the AP reported. This is just the latest example of a country using dogs to identify individuals who are infected with the SARS-CoV-2 coronavirus. Clinical laboratory managers and pathologists have seen other examples of dogs being trained to identify different diseases or health conditions.
In fact, dogs have been shown to be highly accurate at spotting disease in humans and the practice is becoming common worldwide. But could dogs achieve the required clinical accuracy and reproducibility in detecting disease for the procedure to be translated into clinical practice?
Smelling Disease as a Clinical Laboratory Diagnostic
Clinical laboratory professionals are quite familiar with the concept of the human body producing volatile chemicals that can serve as biomarkers for disease or illness. Dark Daily has previously reported on multiple breath/aroma-based diagnostic clinical laboratory tests going as far back as 2013.
But it is in the use of dogs to spot COVID-19 infections in humans where this type of breath/aroma-based diagnostic test research is making a notable impact.
“Even if this approach were not warranted as a clinical diagnostic procedure, trained dogs could be deployed at airports, train stations, sporting events, concerts, and other public places to identify individuals who may be positive for SARS-CoV-2, the coronavirus that causes the COVID-19 illness,” we wrote. “Such an approach would make it feasible to ‘screen’ large numbers of people as they are on the move. Those individuals could then undergo a more precise medical laboratory test as confirmation of infections.”
According to the researchers, individuals with a COVID-19 infection emit a unique odor that is present in sweat samples. The six Labrador retrievers used in the research were able to detect the presence of COVID-19 with an impressive 95% accuracy rate in more than 1,000 samples presented to them, the AP reported.
A Labrador Retriever named Bobby (above) sniffs sample of human sweat through containers to detect COVID-19 coronavirus at Veterinary Faculty, Chulalongkorn University in Bangkok. Thailand has deployed a canine virus detection squad to help provide a fast and effective way of identifying people with COVID-19 as the country faces a surge in cases, with clusters found in several crowded slum communities and large markets. Clinical laboratory professionals and pathologists will find it interesting that the dogs are given a sample of sweat, each presented in a unique container. Thus, the dogs never are in the presence of the humans who provided the specimens. (Photo and caption copyright: AP/Sakchai Lalit)
To perform the study, the scientists placed sweat samples in metal containers and allowed the dogs to sniff each sample. If no trace of the infection was present, the dogs simply walked past the container. If the disease was detected in a particular sample, the dogs would sit down in front of the container.
Would Spicy Food Interfere with Dogs’ Ability to Detect COVID-19?
The head of the research team, Professor Kaywalee Chatdarong, PhD, noted that other countries also have been using canines to detect the presence of COVID-19. She did have some concerns that the utilization of dogs for this purpose may not work in Thailand due to their often-spicy cuisine. However, since the samples used were from students and faculty at the university, as well as people from the surrounding area, the cuisine did not seem to affect the study results, the AP reported.
Thailand is facing a surge in COVID-19 cases with recent clusters reported at construction sites, crowded neighborhoods, and large markets. The research team plans to use the canines in mobile units in communities suspected of being hotspots for the disease.
A major plus of using dogs to sniff out the disease from sweat samples is the ability to test people who may not be able to get out of their homes to be tested.
“People can simply put cotton balls underneath their armpits to collect sweat samples and send them to the lab,” Suwanna Thanaboonsombat, a volunteer who collects samples and brings them to the clinical laboratory for testing, told the AP. “And the result is quite accurate.”
According to the US Centers for Disease Control and Prevention (CDC), dogs can become infected with the SARS-CoV-2 coronavirus. However, their chances of transmitting the disease to humans is extremely low. Nevertheless, to ensure the dogs do not become infected with COVID-19 themselves, the researchers designed the sample containers to avoid contact between the samples and the dogs’ noses.
Living Animals Come with Limitations
While dogs can provide a quick and inexpensive method of testing for COVID-19, they do have limitations.
“5 p.m. is their dinner time. When it’s around 4:50, they will start to be distracted. So, you can’t really have them work anymore,” Chatdarong told the AP. “And we can’t have them working after dinner either because they need a nap. They are living animals and we do have to take their needs and emotions into consideration. But for me, they are heroes and heroines.”
Using Dogs to Detect COVID-19 in Other Countries
Last fall, the Helsinki Airport in Finland announced it would use a team of trained dogs to detect the presence of COVID-19 among visitors to the airport to ensure the health and safety of its customers and their families, and to help prevent the spread of SARS-CoV-2 in Finland.
Being tested for the coronavirus at the Helsinki airport in Finland does not require direct contact with a dog. Individuals simply need to swipe their skin with a test wipe and drop the wipe into a cup. The cup is then given to a dog that is working in a separate booth (shown above), which protects both the dog and the dog’s handler from contamination. All tests are processed anonymously and anyone testing positive for COVID-19 is directed to a health information point located at the airport. (Photo copyright: Finavia.)
“We are among the pioneers. As far as we know no other airport has attempted to use canine scent detection on such a large scale against COVID-19,” said Airport Director Ulla Lettijeff in a Finavia press release. “This might be an additional step forward on the way to beating COVID-19.”
In addition to being “man’s best friend,” dogs serve valuable purposes in the medical community. Their strong sense of smell may render them useful in the detection of and fight against illnesses, including COVID-19.
Whether the performance and accuracy of individual dogs can be validated with acceptable quality control (QC) procedures remains to be seen. Medical laboratory managers and pathologists understand the challenges presented with demonstrating accuracy and reproducibility with this method of diagnostic testing. That obstacle has prevented research outcomes from being translated into clinical practice.
Hello primary diagnosis of digital pathology images via artificial intelligence! Goodbye light microscopes!
Digital pathology is poised to take a great leap forward. Within as few as 12 months, image analysis algorithms may gain regulatory clearance in the United States for use in primary diagnosis of whole-slide images (WSIs) for certain types of cancer. Such a development will be a true revolution in surgical pathology and would signal the beginning of the end of the light microscope era.
A harbinger of this new age of digital pathology and automated image analysis is a press release issued last week by Ibex Medical Analytics of Tel Aviv, Israel. The company announced that its Galen artificial intelligence (AI)-powered platform for use in the primary diagnosis of specific cancers will undergo an accelerated review by the Food and Drug Administration (FDA).
FDA’s ‘Breakthrough Device Designation’ for Pathology AI Platform
Ibex stated that “The FDA’s Breakthrough Device Designation is granted to technologies that have the potential to provide more effective treatment or diagnosis of life-threatening diseases, such as cancer. The designation enables close collaboration with, and expedited review by, the FDA, and provides formal acknowledgement of the Galen platform’s utility and potential benefit as well as the robustness of Ibex’s clinical program.”
“All surgical pathologists should recognize that, once the FDA begins to review and clear algorithms capable of using digital pathology images to make an accurate primary diagnosis of cancer, their daily work routines will be forever changed,” stated Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report. “Essentially, as FDA clearance is for use in clinical care, pathology image analysis algorithms powered by AI will put anatomic pathology on the road to total automation.
“Clinical laboratories have seen the same dynamic, with CBCs (complete blood counts) being a prime example. Through the 1970s, clinical laboratories employed substantial numbers of hematechnologists [hematechs],” he continued. “Hematechs used a light microscope to look at a smear of whole blood that was on a glass slide with a grid. The hematechs would manually count and record the number of red and white blood cells.
“That changed when in vitro diagnostics (IVD) manufacturers used the Coulter Principle and the Coulter Counter to automate counting the red and white blood cells in a sample, along with automatically calculating the differentials,” Michel explained. “Today, only clinical lab old-timers remember hematechs. Yet, the automation of CBCs eventually created more employment for medical technologists (MTs). That’s because the automated instruments needed to be operated by someone trained to understand the science and medicine involved in performing the assay.”
Primary Diagnosis of Cancer with an AI-Powered Algorithm
Surgical pathology is poised to go down a similar path. Use of a light microscope to conduct a manual review of glass slides will be supplanted by use of digital pathology images and the coming next generation of image analysis algorithms. Whether these algorithms are called machine learning, computational pathology, or artificial intelligence, the outcome is the same—eventually these algorithms will make an accurate primary diagnosis from a digital image, with comparable quality to a trained anatomic pathologist.
How much of a threat is automated analysis of digital pathology images? Computer scientist/engineer Ajit Singh, PhD, a partner at Artiman Ventures and an authority on digital pathology, believes that artificial intelligence is at the stage where it can be used for primary diagnosis for two types of common cancer: One is prostate cancer, and the other is dermatology.
On June 17, Ajit Singh, PhD (above), Partner at Artiman Ventures, will lead a special webinar and roundtable discussion for all surgical pathologists and their practice administrators on the coming arrival of artificial intelligence-powered algorithms to aid in the primary diagnosis of certain cancers. Regulatory approval for such solutions may happen by the end of this year. Such a development would accelerate the transition from light microscopes to a fully digital pathology workflow. Singh is shown above addressing the 2018 Executive War College. (Photo copyright: The Dark Report.)
“It is now possible to do a secondary read, and even a first read, in prostate cancer with an AI system alone. In cases where there may be uncertainty, a pathologist can review the images. Now, this is specifically for prostate cancer, and I think this is a tremendous positive development for diagnostic pathways,” he added.
Use of Digital Pathology with AI-Algorithms Changes Diagnostics
Pathologists who are wedded to their light microscopes will want to pay attention to the impending arrival of a fully digital pathology system, where glass slides are converted to whole-slide images and then digitized. From that point, the surgical pathologist becomes the coach and quarterback of an individual patient’s case. The pathologist guides the AI-powered image analysis algorithms. Based on the results, the pathologist then orders supplementary tests appropriate to developing a robust diagnosis and guiding therapeutic decisions for that patient’s cancer.
In his interview with The Dark Report, Singh explained that the first effective AI-powered algorithms in digital pathology will be developed for prostate cancer and skin cancer. Both types of cancer are much less complex than, say, breast cancer. Moreover, the AI developers have decades of prostate cancer and melanoma cases where the biopsies, diagnoses, and downstream patient outcomes create a rich data base from which the algorithms can be trained and tuned.
This webinar is organized as a roundtable discussion so participants can interact with the expert panelists. The Chair and Moderator is Ajit Singh, PhD, Adjunct Professor at the Stanford School of Medicine and Partner at Artiman Ventures.
The panelists (above) represent academic pathology, community hospital pathology, and the commercial sector. They are:
Because the arrival of automated analysis of digital pathology images will transform the daily routine of every surgical pathologist, it would be beneficial for all pathology groups to have one or more of their pathologists register and participate in this critical webinar.
The roundtable discussion will help them understand how quickly AI-powered image analysis is expected be cleared for use by the FDA in such diseases as prostate cancer and melanomas. Both types of cancers generate high volumes of case referrals to the nation’s pathologists, so potential for disruption to long-standing client relationships, and the possible loss of revenue for pathology groups that delay their adoption of digital pathology, can be significant.
On the flip side, community pathology groups that jump on the digital pathology bandwagon early and with the right preparation will be positioned to build stronger client relationships, increase subspecialty case referrals, and generate additional streams of revenue that boost partner compensation within their group.
Also, because so many pathologists are working remotely, Dark Daily has arranged special group rates for pathology practices that would like their surgical pathologists to participate in this important webinar and roundtable discussion on AI-powered primary diagnosis of pathology images. Inquire at info@darkreport.com or call 512-264-7103.
Outspoken Wecht wants readers to understand ‘the multifaceted challenges of the interface of law and medicine’
Pathologists will recognize the name of nationally-acclaimed forensic pathologist Cyril Wecht, MD, JD, who for more than a half-century has been at the center of many of the country’s highest-profile civil and criminal cases. Thus, Dark Daily readers will be intrigued to learn the so-called “godfather of forensic pathology” has published a memoir that takes readers behind the scenes of many of his most controversial forensic pathology cases.
In his recently published memoir (above), forensic pathologist Cyril Wecht, MD, JD, offers readers an inside look at some of his most controversial cases, as well as a defense of his own brushes with the legal system. Anatomic and clinical pathologists may be especially intrigued by Wecht’s description of how “he was acquitted on charges of personally profiting from his office as Allegheny County Coroner” during a federal public corruption charge that was dismissed in 2008, the book’s description states. (Photo copyright: Exposit Books.)
A ‘No-Holds-Barred’ Account
According to TribLIVE, the book—written by Wecht and award-winning writer/filmmaker Jeff Sewald—is a “no-holds-barred account” of Wecht’s personal and professional life. Among the more interesting tidbits are details regarding Wecht’s 1972 discovery that JFK autopsy materials and specimens had gone missing.
“They had been in the government’s possession, so nobody could have touched them, but now the metal container which has held John Kennedy’s brain in formalin was no longer on the list of contents. In addition, various photographs and microscopic tissue slides were also no longer listed. The President’s brain was missing!” wrote Wecht, who argued Lee Harvey Oswald did not act alone in killing JFK and may not have fired the shots that killed him.
In 2006, Wecht faced an 84-count federal public corruption trial, which resulted in him resigning as Alleghany, Pa. medical examiner, the Pittsburgh Post-Gazette reported. In his memoir, Wecht wrote extensively about his public corruption trial. TribLIVE noted Wecht “expresses particular disgust” over the accusation that he supplied Pittsburgh’s Carlow University with cadavers in exchange for use of their laboratory space for his own practice. His trial ended in a hung jury.
“The body-snatching issue was seized upon by the media and was the subject of some of the most horrible cartoons ever,” Wecht wrote. “What made them especially horrible was the fact that I believe anti-Semitism was at their core. They made me look wicked and shadowy, like a ‘Shylock’ who was willing to stoop as low as selling human corpses for a handful of shekels. It was sickening.”
Wecht became known nationally through media appearances and his many decades of work as a medical-legal consultant in civil and criminal cases. At the 2000 Forensic Science and the Law Conference, television host and political commentator Geraldo Rivera, JD, stated, “I’ve known Cyril Wecht for most of my 30-year broadcasting career, and my respect for him has only grown over the decades. His skills as an attorney, as a pathologist, as a medical examiner are legendary.
“Dr. Wecht has guided my audiences through our coverage of crimes ranging from the Kennedy assassination to the O.J. Simpson trial to the JonBenet Ramsey murder mystery,” Rivera added. “And whether or not my audiences knew it, they were getting an education in forensic science—and a lesson in how medical science is applied to this country’s criminal laws.”
An ‘Expert’ and an ‘Irritant’
Though also certified in anatomic pathology and clinical pathology, Wecht has spent his career as a forensic pathologist focused on determining the cause of death. He has performed approximately 17,000 autopsies and has supervised, reviewed, or been consulted on approximately 30,000 additional postmortem examinations, the Cyrilwecht.com website states.
Cyril Wecht, MD, JD (above), told the Pittsburgh Jewish Chronicle that he wrote this memoir so readers could understand the “… complexity and the multifaceted challenges of the interface of law and medicine, specifically in the realm of pathology, and how important it is for justice to be served, with the input from forensic science, and how the system can be subverted, perverted, suppressed, and manipulated.” (Photo copyright: Pittsburg Business Times.)
Pathologists who followed Wecht’s career may know of his reputation “as both an expert and an irritant,” noted the Pittsburg Post-Gazette. For his part, Wecht stated, “If I had been a bit more diplomatic and patient, and a little less antagonistic and controversial, I might have achieved more,” the newspaper reported.
Anyone interested in forensic pathology will likely enjoy reading the behind-the-scenes stories from Wecht’s more than six decades of work. But Wecht’s memoir should be particularly intriguing and informative for clinical and anatomic pathologists, as well as all medical laboratory scientists.
Acceptance of digital pathology and whole-slide imaging is now almost universal among academic health center pathology departments and the nation’s largest pathology companies
Across the United States, many private practice anatomic pathology groups now recognize that digital pathology is the path forward for the entire profession. During the past decade, most academic pathology departments and large pathology lab companies have incorporated digital pathology (DP) and whole-slide imaging (WSI) into many of their labs’ daily activities.
However, in community hospital-based anatomic pathology groups, there have been barriers to even the partial adoption of digital pathology. The two biggest barriers are well-known and discussed frequently at conferences and in the literature.
Some Pathologists Reluctant to Give Up Light Microscopes
One recognized barrier to wider adoption of DP is the reluctance of many long-serving pathologists to give up their familiar light microscopes and glass slides so they can make the transition to reading pathology images on a computer screen. These pathologists remain loyal to the tools and workflows that have served them well throughout their careers.
They generally oppose their group’s move to digital pathology when the subject is discussed in partner meetings and strategic retreats. Since many pathology groups require 100% of partners or shareholders to approve major business decisions, even one recalcitrant and stubborn pathologist-partner can block the motion to adopt digital pathology that is supported by most partners.
The second barrier is the fully-loaded cost to acquire, validate, implement, and use a digital pathology system with whole-slide imaging. A full-featured scanner can cost $250,000 or more and acquiring all the software, systems, and tools needed by a group to fully incorporate digital pathology into daily workflow can easily total $500,000 to $1,000,000.
This substantial commitment of a pathology group’s capital can trigger the same intense debates as the original question of whether the pathologists in the group should adopt DP and WSI. And, not surprisingly, in most pathology groups the same dynamics come into play when votes are tallied on the motion for the pathology group to commit the funds necessary to acquire a digital pathology system, the scanners, and associated tools.
Just one or two partner holdouts can block the decision to spend the money, despite that most of the pathologist partners are ready to make the commitment.
More Community Pathology Groups Considering Digital Pathology
Yet, the momentum in favor of adopting DP and WSI continues to build. “Those pathology labs that are early adopters report multiple clinical and financial benefits. These can include generating positive financial outcomes—including the ability to attract new clients, increasing case referrals, and generating new sources of revenue to the group. In turn, the increased revenue can allow the group to increase pathologist compensation,” said Robert L. Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.
Every day, more anatomic pathologists in the United States use a digital pathology system with a workstation (like above) to view whole-slide images and manage their daily caseload. Most academic center pathology departments use digital pathology, as do many of the nation’s largest pathology lab companies. (Photo copyright: WizardHealth.)
“We are in a time when health insurers are hammering away at the reimbursement paid to anatomic pathologists,” Michel continued. “Year after year, payers cut reimbursement for technical component and professional component services. They exclude many pathology groups from payer networks. That is why more community pathology groups are recognizing several important benefits with the use of DP and WSI that can increase a pathology group’s revenue and boost its pathologist compensation.
Community Pathology Groups Can Use Digital Pathology to Add Value
Equally important, there are specific ways that digital pathology and whole-slide imaging increase the value of the clinical services pathologists deliver to their client physicians. These dual benefits of DP are often overlooked—or not discussed—when community pathology groups conduct their annual retreats and debate the key points of when to adopt—and how to fund—a digital pathology system for their group. These benefits range from giving physicians a faster diagnostic answer on their cancer cases to helping the group’s subspecialist pathologists get more case referrals from physicians in other states.
“It’s important for all surgical pathologists to recognize several realities in today’s pathology marketplace,” Michel noted. “First, almost every sector in healthcare is digitizing itself. Reinforcing this trend is the federal government’s mandates for interoperability across EHRs, HISs, and LISs. Any private pathology group practice that lags in its adoption of digital capabilities and digital images will find itself falling farther and farther behind as physicians switch their case referrals to other pathology labs that have converted to digital pathology and whole-slide images.
“Second, pathology groups that adopt DP and WSI put themselves in a position to build market share in their service region, while at the same time increasing case referrals for their in-house subspecialist pathologists from throughout the United States,” Michel continued. “Also, when the histology is done locally, the local pathology group can deliver faster diagnostic answers and provide digital images as appropriate to referring physicians and hospitals in that region without the need to transport glass slides by couriers.
“Third—and this is an often-overlooked benefit of digital pathology—the local pathology group with DP and WSI can recruit today’s graduating pathology residents and fellows who have trained on DP and WSI. These new pathologists typically limit their job search to pathology groups that have gone digital,” Michel noted. “Millennial pathologists trained with digital images in their residency program. They are eager to work with the automated image analysis algorithms now coming to market.”
On Thursday, May 27, at 1:00 PM EDT, Keith Kaplan, MD, Chief Medical Officer of Corista (left), Andrew Evans, MD, Medical Director of Laboratory Medicine at Mackenzie Health (center left), William DeSalvo, President of Collaborative Advantage Consulting and Manager of Histology Operations at Sonora Quest Laboratories in Tempe, Ariz. (center right), and Lisa-Jean Clifford, COO and Chief Strategy Officer at Gestalt Diagnostics (right) will present “Adopting Digital Pathology on a Budget: Getting Started, Knowing What’s Feasible, and Funding Your DP from Overlooked Sources.” Anatomic pathologists, clinical laboratory directors, laboratory managers, clinical pathologists, and laboratory technicians will gain a critical understanding of which components a fully integrated digital pathology system requires, the differences between your lab’s existing LIS and a digital pathology system, budget-minded approaches to buying the components of a digital pathology system and implementing them in a stepwise fashion, and much more! (Photo copyright: Dark Daily.)
Recognizing the significant capital investment needed to acquire and deploy digital pathology and WSI, one goal of the webinar’s panel of experts is to identify ways that pathology groups can go digital on a budget. “We will do our best to identify different ways that pathology groups with limited financial resources can get into digital pathology,” said Keith Kaplan, MD, Chief Medical Officer at Corista in Concord, Mass., who will chair the upcoming webinar. “This may be the first public presentation where there is candid information about different financial strategies that your pathology group can utilize to acquire the scanners, the DP systems, and the associated tools needed for a full conversion to daily digital pathology.”
Don’t overlook how your participation in this webinar can be the foundation for helping your pathology group practice develop a timely, cost-effective path forward to introduce digital pathology and whole-slide imaging. Use of DP and WSI can become an important factor in helping your group offset payer prices cuts, develop new clients and sources of revenue, and increase pathologist compensation.
Click HERE to register today (or copy and paste this URL into your browser: https://www.darkdaily.com/webinar/adopting-digital-pathology-on-a-budget/). Make sure to have your pathology practice administrator and your histology manager join you for this important webinar.
In a letter, Congress urged the HHS Secretary to conduct “vigorous oversight and enforces full compliance with the final rule”
Analysis of more than 3,100 hospital websites by The Wall Street Journal (WSJ) has found “hundreds” containing embedded code that prevents search engines from displaying the hospitals’ prices. This is contrary to the Hospital Price Transparency Final Rule (84 FR 65524), passed in November 2019, which requires hospitals to “establish, update, and make public a list of their standard charges for the items and services that they provide,” including clinical laboratory test prices.
“Hundreds of hospitals embed code in their websites that prevented Alphabet Inc.’s Google and other search engines from displaying pages with the price lists,” the WSJ reported. “Among websites where [the WSJ] found the blocking code were those for some of the biggest US healthcare systems and some of the largest hospitals in cities including New York and Philadelphia.”
Additionally, the WSJ found hospitals were finding ways to “hide” the price lists they did display deep within their websites. The prices can be found, but the effort involves “clicking through multiple layers of pages,” on the providers’ websites, the WSJ added.
Lawmakers Put Pressure on CMS
The WSJ report drew the attention of federal lawmakers who weighed in on the current state of hospital price transparency and on the WSJ’s findings in a letter to Xavier Becerra, Secretary of the federal Department Health and Human Services (HHS).
In their letter, members of the Congressional Committee on Energy and Commerce called for HHS “to revisit its enforcement tools, including the amount of civil penalty, and to conduct regular audits of hospitals for compliance.”
Committee members wrote, “The Hospital Price Transparency Final Rule requires hospitals to make public a machine-readable file containing a list of all standard charges for all items and services and to display charges for the hospital’s 300 most ‘shoppable’ services in a consumer-friendly format. We are concerned about troubling reports of some hospitals either acting slowly to comply with the requirements of the final rule or not taking any action to date to comply.”
The letter, which was signed by the committee’s Chairman Frank Pallone (D, New Jersey) and Committee Ranking Member Cathy McMorris Rodgers (R, Washington State), cited the WSJ investigation as well as other analyses of price transparency at US hospitals.
Cynthia Fisher (above), founder of Patient Rights Advocate, told The Wall Street Journal, “In the past there was absolutely no power for the consumer. It was like highway robbery being committed every day by the healthcare system.” Now, Fisher added, “it’s the American consumer who is going to drive down the cost of care.” Clinical laboratories will note that consumer demand for, and federal regulation of, price transparency is not limited to hospitals. All healthcare providers need procedures in place that comply with federal guidelines for transparency. (Photo copyright: Morning Consult.)
Additional Studies Show Major Hospitals “Non-Compliant”
One such study cited by the Congressional committee in its letter to HHS was conducted by Health Affairs, which looked into transparency compliance at 100 hospitals. In a blog post, titled, “Low Compliance from Big Hospitals on CMS’s Hospital Price Transparency Rule,” the study authors wrote “our findings were not encouraging: Of the 100 hospitals in our sample, 65 were unambiguously noncompliant.
“Of these 65,” they added:
“12/65 (18%) did not post any files or provided links to searchable databases that were not downloadable.
“53/65 (82%) either did not include the payer-specific negotiated rates with the name of payer and plan clearly associated with the charges (n = 46) or were in some other way noncompliant (n = 7).
“We are troubled by the finding that 65 of the nation’s 100 largest hospitals are clearly noncompliant with this regulation. These hospitals are industry leaders and may be setting the industrywide standard for (non)compliance; moreover, our assessment strategy was purposefully conservative, and our estimate of 65% noncompliance is almost certainly an underestimate,” Health Affairs concluded.
A previous similar investigation by The Washington Post called compliance by hospitals with the pricing disclosure rules “spotty.”
So, why is complying with the federal price transparency rule so challenging for the nation’s largest hospitals? In its reporting on the Wall Street Journal analysis, Gizmodo wrote, “we’ve seen healthcare providers struggle to implement the new law due, in part, to how damn ambiguous it is. Past reports have pointed out that the vague requirements hoisted onto hospitals as part of these new rules often result in these pricing lists being difficult—if not downright—impossible to find, even if the lists are technically ‘machine-readable’ and ‘on the internet.’”
“Meanwhile,” Gizmodo continued, “as [the WSJ] points out, the order doesn’t specify exactly how much detail these hospitals are even supposed to offer on their pricing sheets—meaning that it’s up to the hospitals whether they want to include rates pertaining to specific health insurance plans, or whether they want to simply include different plan’s rates in aggregate.”
And in their letter to HHS, the Congressional committee wrote, “… some hospitals are providing consumers a price estimator tool instead of providing the full list of charges and payer-negotiated rates in one file, and some are making consumers fill out lengthy forms for estimates. Some hospitals also are providing the data in a non-useable format or failing to provide the codes for items and services.”
Clinical Laboratories Must Comply with Price Transparency Rules
Clearly, transparency in healthcare has a long way to go. Nevertheless, hospital medical laboratory leaders should expect reinforcing guidance from CMS on making price information on commonly used clinical laboratory tests fully accessible, understandable, and downloadable.
As Dark Daily noted in previous coverage, consumer demand for price transparency is only expected to increase. Clinical laboratories need to have a strategy and process for helping consumers and patients see test prices in advance of service.
A New York Times report suggests that frequent testing is still the best approach to controlling spread of the SARS-CoV-2 coronavirus
Many colleges and universities go to great lengths to screen their students for signs of COVID-19 using technologies that include fever scanners, heart-rate monitors, and symptom-checking apps. But a recent report in The New York Times, titled, “Colleges That Require Virus-Screening Tech Struggle to Say Whether It Works,” suggests that academic institutions would be better off adopting frequent clinical laboratory testing for the SARS-CoV-2 coronavirus, even if it is more expensive than symptom screening.
This shouldn’t be a surprise to pathologists and other medical laboratory professionals who have followed news and research about the pandemic. Back in Sept. 2020, the federal Centers for Disease Control and Prevention (CDC) in a media statement noted that “symptom-based screening has limited effectiveness because people with COVID-19 may have no symptoms or fever at the time of screening, or only mild symptoms.”
That same month, Medscape reported that presidential advisor Anthony Fauci, MD, said, “It is now clear that about 40%-45% of infections are asymptomatic.”
But this hasn’t prevented educational institutions from investing in costly screening technologies. One cited by The New York Times (NYT) was the University of Idaho, where 9,000 students live on or near campus. The university has spent $90,000 on fever scanners resembling airport metal detectors, the paper reported, but as of early March, the units had identified fewer than 10 people with high skin temperatures.
“Even then, university administrators could not say whether the technology had been effective because they have not tracked students flagged with fevers to see if they went on to get tested for the virus,” the NYT reported, adding that many other institutions that adopted screening technologies have failed to systematically measure the effectiveness of these approaches.
“The moral of the story is you can’t just invest in this tech without having a validation process behind it,” infectious-disease epidemiologist Saskia Popescu PhD, MPH, of George Mason University told The New York Times.
Rising COVID-19 Infections on College Campuses
These efforts have come amid increasing COVID-19 infection rates on many US campuses. In “Cases Rise, Restrictions Begin,” Inside Higher Ed reported that large universities were doing better than they had in the fall 2020 semester, but that “other campuses—including those that kept cases low in the fall—are seeing numbers rise.” One such campus was Boston College, which cast blame on students who were not following safety protocols.
For its story, The New York Times surveyed more than 1,900 US colleges and universities as part of an effort to track outbreaks on campus. Respondents reported more than 120,000 campus-related COVID-19 cases between Jan. 1 and March 2, 2021, but because institutions measure outbreaks in different ways, the NYT reported that this is likely an undercount. Overall, institutions reported more than 535,000 cases since the pandemic began, according to the survey.
Clinical Laboratory Testing Still Ongoing on College Campuses
School administrators told The New York Times that despite questions about the usefulness of screening tools, this approach is still worthwhile as reminders for students to follow other protocols, such as mask wearing.
And universities have not abandoned testing for COVID-19. For example, The New York Times noted that students at the University of Idaho are tested at least twice each semester, and the school is also testing wastewater to identify outbreaks of SARS-CoV-2.
The Ohio State News, a publication of Ohio State University, reported in late February that it had tested 30,000 people in a single week, accounting for 12% of the COVID-19 tests conducted in Ohio. At the start of the fall semester, the university was sending test samples to a private company in New Jersey, but later it began processing samples at the on-campus Applied Microbiology Services Lab (AMSL).
“By the start of spring semester, the AMSL was processing about 85% of Ohio State’s COVID-19 tests,” the university reported, for a likely savings of $30 million to $40 million. Leaders of the testing program expect that they can realistically conduct 35,000 tests per week.
Chris Marsicano, PhD (above), a professor and researcher at Davidson College, told Inside Higher Ed that many institutions are relying on antigen testing, which is less costly but also less reliable than PCR (polymerase chain reaction) tests. “PCR tests are expensive,” he said. “Just because you’re testing multiple times a week doesn’t mean you’re catching all the cases.” Marsicano leads the institution’s College Crisis Initiative. Clinical laboratory leaders can attest to Marsicano’s statement. (Photo copyright: Twitter.)
Using Technology for COVID-19 Contact Tracing
In addition to symptom screening, some universities have adopted technologies that track student movement on campus for contact-tracing purposes. But again, the benefits are questionable. For example, Bridgewater State University in Bridgewater, Mass. asked students to scan QR codes at various locations, but only one-third were doing so, The New York Times reported. Another system at the university records entry to campus buildings when students swipe their IDs.
“We found what we need is tests and more tests,” clinical psychologist Christopher Frazer, Psy.D., Executive Director of the university’s wellness center, told The New York Times. He said that students on campus are tested once a week. When they have tested positive, contact tracers “often learned much more about infected students’ activities by calling them than by examining their location logs,” the NYT reported.
Colleges and universities are also banking on vaccination to reduce the spread of the virus, Inside Higher Ed reported. Some will require all students to be vaccinated for the fall semester, but such mandates are facing legal and political hurdles. For example, executive orders by Texas Governor Greg Abbott and Florida Governor Ron DeSantis may prohibit institutions in those states from imposing vaccination requirements.
As colleges and universities struggle to deal with the challenges of COVID-19, clinical laboratories have resources for staying up to date on current testing and tracking technologies in use on campuses. For example, the CDC is funding a program to facilitate sharing of best practices and other information. Inside Higher Ed reported that the Higher Education COVID-19 Community of Practice (CoP) will include a discussion board, webinars, and a searchable database of info uploaded by participating institutions.
