January 2021

January 2021—Susan Butler-Wu, PhD, D(ABMM), is clear about who she is and what she does. “I’m just a microbiologist,” she says. But in a viral pandemic, a microbiologist—and everyone else associated with clinical laboratory testing—becomes so much more than the job title. (For the record, Dr. Butler-Wu is director of the clinical microbiology laboratory, LAC+USC Medical Center, Los Angeles, and associate professor of clinical pathology, Keck School of Medicine of USC.) Likewise, a test becomes more than a lab value. The very fact that testing has become the focus of national discourse is a testament to the upending nature of the pandemic, she says. “The public are having conversations about Ct values. It’s mind-blowing.”

January 2021—It’s a watershed moment when an influential standard-setting organization, the American Cancer Society, announces that a test widely used for decades should be supplanted—especially when the test is the linchpin of the most successful cancer screening program in U.S. history.

January 2021—The use of molecular assays at the point of care is exciting but a bit scary. That’s how Raquel Martinez, PhD, D(ABMM), described the state of the science for molecular infectious disease POC testing when she spoke in a virtual AMP session in November with Omai Garner, PhD, D(ABMM), of UCLA Health.

January 2021—Wrestling with rapid test shortfalls and with open laboratory positions. Expecting the post-holiday surge, frustrated by federal level disconnect. That is what Compass Group members were doing and feeling on Dec. 1 last year, when they gathered on Zoom for another conversation about COVID-19.

January 2021—Mary E. Fowkes, MD, PhD, a member of the CAP Board of Governors since 2019, died on Nov. 15, 2020. Dr. Fowkes was an associate professor of pathology and the director of neuropathology and the autopsy service, Icahn School of Medicine at Mount Sinai Hospital. She was also an adjunct professor at the State University of New York College of Environmental Science and Forestry in Syracuse.

January 2021—A CAP Practice Management Network will be online Feb. 9 for CAP members and their practice staff who want to share problems and best practices and learn from the practice management insights of others. It will be a “no-judgment zone, a safety zone, a neutral territory,” says Brian H. Le, MD, MBA, co-coordinator of the network and vice chair of the CAP Practice Management Committee, developer of the network. “A lot of practices and new-in-practice pathologists encounter a competitive spirit that sometimes doesn’t serve us well,” says Dr. Le, a pathologist based at Novant Health in North Carolina.

January 2021—Hanging over the publication of the 2021 Medicare physician fee schedule on Dec. 1 was an overall decrease of nine percent to pathology services and similar cuts to other specialty physicians. The Centers for Medicare and Medicaid Services in 2019 announced these payment cuts would offset increases to evaluation and management services, which are typically billed during physician office visits. The CAP through its advocacy opposed the cuts to pathologists and sought to stop them from taking effect.

January 2021—Central nervous system high-grade neuroepithelial tumor with BCOR alteration (CNS HGNET-BCOR) is a rare and genetically distinct CNS neoplasm that occurs predominantly in the pediatric population. Previously, these tumors had been categorized as primitive neuroectodermal tumors of the central nervous system (CNS-PNET).

January 2021—COVID-19 and coagulation testing were up for discussion on Nov. 20 when six people joined CAP TODAY publisher Bob McGonnagle to talk about that and laboratory labor, relationships with industry and hospital administration, and the distribution of testing. “We’re working with all the manufacturers to support rapid point-of-care testing to manage hot spots that will pop up once there is a vaccine,” said Orchard Software’s Curt Johnson. With Johnson and McGonnagle on the call were Oksana Volod, MD, of Cedars-Sinai Medical Center; Neil Harris, MBChB, MD, of the University of Florida; Annie Winkler, MD, MSc, of Instrumentation Laboratory; Nichole Howard, MBA, of Diagnostica Stago; and Jason Lam, MBA, MLS, of Siemens Healthineers. Drs. Volod and Harris are members of the CAP Hemostasis and Thrombosis Committee.

January 2021—Although the challenges we face due to the COVID-19 pandemic are significant, adapting to our new circumstances can be a driver for positive change. Cytology education had started using virtual learning resources in the past few years with great variation among institutions and countries. The pandemic forced the community to embrace virtual learning in a variety of modalities. These changes may lead to lasting improvements in the quality and accessibility of educational opportunities for cytology trainees, and not just in the United States. In the same way, we are witnessing the exponential growth of digital pathology as applied to surgical pathology. In cytopathology the applications have been limited to telecytopathology in the setting of rapid on-site evaluation (ROSE) for interventional procedures. The difficulties in dealing with multilayered focus have been given as reasons not to pursue whole slide imaging for cytology. As the cytology community has, even if reluctantly, gained experience with remote sign-out, we may see a push for digital imaging for primary diagnosis in cytology.

January 2021—Rapid on-site evaluation (ROSE) for cytology specimens is performed at many institutions to improve the quality of health care by proper triage of obtained material to increase the diagnostic yield, or to direct appropriate investigation. It also helps to control health care costs by reducing the rate of nondiagnostic specimens, unnecessary passes, and repeat procedures. The number of procedures requiring ROSE is growing due to the increase in the number of platforms used to perform minimally invasive procedures.

January 2021—Please join me in a collective sigh of relief: 2020 is finally over. I am glad that awful year is behind us at last and sincerely hope that 2021 will be kinder and gentler to us all. From my perspective, 2021 is already off to a better start because it gives us a reason to celebrate. In 1946, 140 board-certified pathologists gathered in Chicago on Dec. 12 and 13 and formed the College of American Pathologists. This year is our 75th anniversary.

January 2021—Annual expenditures for clinical laboratory testing account for approximately $71.6 billion of health care costs and represent about 2.4 percent of all health care spending. While laboratory testing is critical, recommendations of the Choosing Wisely initiative focus on reducing laboratory costs and unnecessary testing, in part through dialogue between physicians and patients. Specialty societies widely accept and participate in Choosing Wisely recommendations, but outcomes of the initiative are largely unknown. The American Society for Clinical Pathology put forth 25 recommendations for Choosing Wisely, of which the 13th recommendation stated that serum lipase is the preferred test for diagnosing acute pancreatitis because lipase peaks by 24 hours and remains elevated for eight to 14 days. It was also recommended that serum amylase tests not be ordered with serum lipase tests because one or the other is sufficient for the diagnosis.

January 2021—The authors conducted a review of postmortem pulmonary histopathologic findings of COVID-19 pneumonia in patients who had a spectrum of disease course that ranged from rapid demise to prolonged hospitalization. They analyzed histopathologic findings in postmortem lung tissue from eight patients who died from COVID-19 pneumonia. Immunohistochemistry and next-generation sequencing (NGS) were used to detect the virus. Diffuse alveolar damage (DAD) was seen in all cases with a spectrum of acute phase or organizing phase, or both. IHC with monoclonal antibodies against SARS-CoV-2 viral nucleoprotein and spike protein detected virus in areas of acute but not organizing DAD.

January 2021—Circular RNAs are a novel class of recently discovered RNA with emerging roles in gene regulation, homeostasis, and disease. They are generated by ligation of the distal ends to form a circular product and originate from parental-coding genes and noncoding regions of the genome. Circular RNAs (circRNAs) are widespread in the plant and animal kingdoms and conserved in multiple species. Recent literature suggests that they inhibit micro RNA (mi­RNA), an important class of RNAs that regulates gene expression by binding to messenger RNAs (mRNA). Therefore, the post-transcriptional regulation of gene expression by RNAs has expanded to include a circRNA–mi­RNA–mRNA regulatory network.

January 2021—A major barrier to adopting whole slide imaging for primary diagnosis in the United States was FDA regulatory approval. However, the FDA approved marketing of the first whole slide imaging (WSI) system for digital pathology in 2017. The agency subsequently cleared Leica’s Aperio AT2 DX system for in vitro diagnostic use to aid pathologists in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed paraffin-embedded tissue. The authors conducted a study in which they compared pathologists’ primary diagnoses rendered through the use of WSI versus standard glass microscopy. Their multicenter, double-blind, randomized clinical trial was conducted at five sites: the University of California Davis, Pacific Rim Pathology, Dignity Health, TriCore Reference Laboratories, and Intermountain Healthcare.

Q. If an instrument is moved a short distance, is it necessary to conduct revalidation? Read answer. Q. At what level or time is aPTT considered incorrect? Is an aPTT of less than 22.0 seconds an acceptable result? Read answer.

January 2021—It’s a maxim for any laboratory automation project: Don’t automate until you analyze—the efficiency of current processes, that is. And ARUP Laboratories’ chief operating officer, Jonathan Genzen, MD, PhD, has taken it to heart as the laboratory gears up for large-scale automation projects this year.

January 2021—AstraZeneca’s Tagrisso (osimertinib) has been approved in the U.S. for the adjuvant treatment of adult patients with early-stage EGFR-mutated non-small cell lung cancer after tumor resection with curative intent.

January 2021—The CAP election to fill four positions on the Board of Governors will take place this summer. The CAP is encouraging its members who have been CAP fellows for at least five years and involved in CAP volunteer activities to take the next leadership step.