May 8, 2020 | Compliance, Legal and Medical Malpractice, Digital Pathology, Instruments and Equipment, Laboratory Instruments and Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory testing, management and operation
Due to the “shelter-in-place” order, many anatomical pathologists view digital images at home during the COVID-19 outbreak and demonstrate the value of full-slide imaging, digital pathology, and CMS’s recently revised remote exit policy
COVID-19 has caused many permanent changes in the organization and delivery of health care in the United States. However, the full scope of these changes will not become apparent until the SARS-CoV-2 pandemic has eased. This is especially true for anatomical pathology and the extended use of telepathology, digital pathology, and full-slice imaging in this major.
Since the beginning of March, the specimen referrals and income of the National Anatomical Pathology Team and laboratories have dropped sharply. The dark report (TDR), a sister publication of the "Dark Daily", quantified the severity of this tissue breakdown referred to the pathology group for the first time. In an interview with The Dark Report, Kyle Fetter, Executive Vice President and General Manager of Diagnostic Services at XIFIN, Inc., explained that the number of specimens for pathology clients using XIFIN's revenue cycle management services has decreased by an average of 40%. Moreover, for some pathology sub-specialties, the decline in specimen referrals can be as high as 90%. (See TDR, "Beginning in mid-March, laboratory revenues have dropped significantly," April 20, 2020.)
The College of American Pathologists (CAP) has called on the Centers for Medicare and Medicaid Services (CMS) to allow pathologists to work remotely. In response, CMS issued a memorandum stating: “Due to the public health emergency caused by COVID-19 and the urgent need to expand laboratory capacity, CMS is exercising its Temporary test site under conditions."
Since then, many doctors, including pathologists, have quickly adapted to some form of remote work.
Promote telepathology services to recognize the shortage of anatomical pathologists
The Federal Agency issued a CMS memorandum (QSO-20-21-CLIA) to laboratory investigators on March 26, 2020, stating that if certain conditions are met, CMS will exercise “law enforcement discretion to ensure that pathologists can Remote review of pathological sections".
The CMS’s decision “applies only to the COVID-19 public health emergency” aims to improve capabilities by allowing remote on-site review of clinical laboratory data, results, and pathological slices.
Generally, CLIA cytology regulations (a branch of research that focuses on the biological structure of cells) stipulate that cytology slide preparations must be evaluated in a laboratory that is certified for testing in the cytology subspecialty. However, a swift letter from 37 members of Congress to the Secretary of the U.S. Department of Health and Human Services (HHS) Alex Azar II (MD) stated that “due to the shortage of personnel, Increasing the risk of job burnout, medical errors, and further shortages of personnel due to exposure. The number of COVID-19 cases will increase and peak in the next two months, pushing the existing healthcare system to its limit."
In response to the CMS remote exemption, the CAP Digital and Computational Pathology Committee and the Informatics Committee issued additional guidelines on the CAP website.
The decline in the number of “active pathologists” drives the adoption of telepathology, digital pathology, and full-slide imaging
The current COVID-19 outbreak is only the latest factor that supports remote viewing of anatomical and pathological images and cases. The trend to use telepathology, full-slice imaging (WSI), and digital pathology systems has been growing for several years. Strong economic forces support this trend.
The "Dark Report" was released on June 10, 2019, with the aim of delving into the current challenges facing the anatomical pathology profession. TDR specifically pointed out that a study published in the online public edition of the Journal of the American Medical Association (JAMA) on May 31, 2019, entitled "Trends in the Workforce of Pathologists in the United States and Canada from 2007 to 2017". The author of the study-pathologists in the United States and Canada reported that between 2007 and 2017, the number of active pathologists in the United States decreased from 15,568 to 12,839-a decrease of 17.53%.
TDR pointed out that these findings mean that few pathologists in the United States today are actively handling the steady increase in the number of cases requiring diagnostic review. In turn, this situation may lead to delays in diagnosis, which is detrimental to patient care.
In fact, the National Health Service (NHS) in the UK is dealing with this situation. According to the “Daily Telegraph” report, a quarter of cancer patients in the UK have a biopsy diagnosis delayed by as much as eight weeks. It is widely believed that the UK lacks the number of histopathologists required to drastically shorten the time to diagnosis. To solve this problem, the NHS is implementing a national digital pathology network featuring Amazon's Alexa virtual assistant to provide health advice to British citizens. (See Dark Daily, "The NHS in the UK will use Amazon Alexa to provide official health advice to patients in the UK", December 2, 2019.)
Different forces begin to reshape anatomical pathology
In recent years, the anatomical pathology major has faced increasing financial pressure, shrinking labor force, and a surge in global pathology demand-these problems appear when biopsy and cancer diagnosis require more expertise.
As previously reported by The Dark Daily and The Dark Report, with the US Food and Drug Administration’s approval in April 2017 for the sale of the Philips IntelliSite Pathology Solution (PIPS) Whole Slide Imaging (WSI) system, digital disease Neo-Confucianism gained momentum. The second WSI system to be cleared of FDA approval is Leica Biosystem Imaging's Aperio AT2 DX system.
When talking about the adoption of a digital pathology system (DPS), it is important to realize that digital pathology testing is developing rapidly outside the United States, explained in a new white paper titled "Time-consuming Anatomical Pathology" by Dark Daily Say point of view? Now adopt the economic case of digital technology and artificial intelligence applications. "
Acquiring the knowledge and first-hand experience of adopting digital pathology is critical to the future business development of anatomical pathology services.
Use digital pathology and computing solutions for emerging cancer diagnosis
The adoption of digital pathology can be seen in various specialties of cancer care, especially skin, breast, and prostate. An example is the University of California San Francisco (UCSF) School of Medicine, which adopted digital pathology in February 2015.
UCSF Medical School started with frozen sectioning and then moved to more extensive pathological sections. According to Zoltan Laszik, MD, PhD, the attending physician at the University of California, San Francisco and the professor of clinical pathology in the Department of Pathology and Laboratory Medicine at the University of California, San Francisco, since 2015, the University of California, San Francisco’s medical school has turned to all-digital pathology operations , And has been serialized and adopted by professional.
Laszik is one of the few experts and early adopters of digital pathology, and they collaborated on the new Dark Daily white paper, which is available for free download.
By adopting digital pathology, the slides are digitized using a full slide image scanner, and then analyzed by image viewing software. Although the basic viewing functions are not much different from those provided by microscopes, digitization does bring improvements in laboratory efficiency, diagnostic accuracy, image management, workflow, and revenue growth.
In addition, the white paper explains that in some cases, artificial intelligence (AI)-based computing applications have become an integral part of the digital pathology workflow.
"These developments are important to anatomical pathologists because the traditional pathology business model continues to change at a steady rate," said Robert L. Michel, editor-in-chief of The Dark Report.
Anthony Magliocco, MD, FRCPC, FCAP, President and CEO of Protean BioDiagnostics and former Professor of Pathology and Chairman of Moffitt Cancer Center, also appeared in the white paper. His new pathology service model provides routine pathology services, precision oncology, second opinion, liquid biopsy, genetics and genomics to a cancer center in a specialized laboratory in Florida.
In addition to the white paper, Magliocco will also share his experience in adopting digital pathology in a free webinar titled "Simplify operations, increase revenue, and improve the quality of care: About the use of digital pathology in the laboratory Conclusive evidence of the value of ". The webinar was held on Wednesday, May 13 and hosted by Dark Daily.
To register for this important learning opportunity, please click here or put this URL in your web browser: https://www.darkdaily.com/webinar/streamlined-operations-increased-revenue-higher-quality- of-care-conclusive-evidence-the value of adopting digital pathology in your laboratory/.
These digital pathology technologies represent the innovative movement shaping pathology services now and in the future. Pathologists who want to learn more are encouraged to sign up for the May 13 webinar, which will build on the evidence and comments contained in the new white paper and can be downloaded on demand after the live broadcast for free .
Download the new white paper for free: Anatomic pathology at a tipping point? The economic case of adopting digital technology and artificial intelligence applications now
Sign up for the free webinar on May 13th at 1:00 PM Eastern Time
Clinical Laboratory Improvement Amendment (CLIA) Laboratory Guidelines during COVID-19 Public Health Emergencies
Trends in the workforce of pathologists in the U.S. and Canada from 2007 to 2017
UK NHS will use Amazon Alexa to provide official health advice to UK patients
New telemedicine strategy helps hospitals cope with COVID-19
CMS Memo: QSO-20-21-CLIA, March 26, 2020
Rush and Carter lead successful efforts to ensure that pathologists can meet critical testing needs during the pandemic
Letter from Congress to HHS Secretary Alex Azar II, MD on March 25, 2020
CAP provides remote work exemption for pathologists
The latest update of COVID-19: Frequently Asked Questions about Using Digital Pathology to Log Off Cases Remotely
Laboratory staff mobility: Q-Probes study of 23 clinical laboratories by the American College of Pathologists
The anatomical pathology profession is shrinking?
Experts consider the advantages and disadvantages of DP and WSI systems
Live event update: Administrative Warfare College on Laboratory and Pathology Management
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