June 2021

June 2021—Mastocytosis is not for quitters. Not at any point, from considering the possible diagnosis, to doing a complement of stains, to looking for mutations beyond KIT D816V, to being curious about the presence of mast cells even after making a diagnosis of another myeloid disease. Patients have already learned this grueling lesson. They can easily spend years seeking answers before their disease is properly identified. Pathologists can speed up that process—and the time to do so is now, says Tracy George, MD, chief medical officer and incoming president of ARUP Laboratories, and medical director of hematopathology. Notes Dr. George: “There’s some exciting stuff going on with systemic mastocytosis.” New targeted KIT inhibitors appear to be quite effective, including at least one agent for advanced systemic mastocytosis that has been submitted to the Food and Drug Administration. “We anticipate there’s going to be approval by the FDA this summer,” says Dr. George, who’s been involved in the clinical trials for avapritinib (Blueprint Medicines).

June 2021—If screening for gestational diabetes mellitus were a dance competition, it might have a contest between quickstep and paso doble as its signature event. That tournament could pit the one-step testing protocol (twice as likely to diagnose GDM) against the two-step testing protocol (significantly easier for pregnant women to adhere to).

June 2021—In an AACC virtual session last December, Catherine P. M. Hayward, MD, PhD, of McMaster University, set out the stepwise approach to testing for platelet function disorders, explained the methods used to assess platelet aggregation response, and reported what most clinical labs do.

June 2021—As COVID-19 restrictions halted traditional laboratory inspections, virtual and blended inspections became the stand-ins, and early adopters say there’s much to like and hold on to post-pandemic.

June 2021—For the June 2021 release of updates for the CAP cancer protocols and the corresponding electronic cancer checklists used by electronic health record vendors, pTX and pNX will no longer be selectable options for use by pathologists when assigning pathologic staging based on definitive surgical resection (pTNM). This change is coming after extensive discussions with the American Joint Committee on Cancer (AJCC) and with its unanimous endorsement. Why are we making this change?

June 2021—A brief update on SARS-CoV-2 variant testing and then a look at the latest on the laboratory labor struggle. That’s what Compass Group members provided when they spoke May 4 in another of their monthly calls led by CAP TODAY publisher Bob McGonnagle. “We’ve accepted that if we’re going to solve the [labor] issue,” said Sam Terese of Alverno Laboratories, “we’ll have to create the workforce. They’re not coming to us in any other way.” With McGonnagle and Terese were Bob Stallone and James Crawford, MD, PhD, Northwell; Sterling Bennett, MD, MS, Intermountain; John Waugh, MS, MT(ASCP), Henry Ford; Peter Dysert, MD, Baylor Scott & White; Steven Carroll, MD, PhD, Medical University of South Carolina; Stan Schofield, MaineHealth; Gregory Sossaman, MD, Ochsner; Clark Day, Indiana University; Diana Kremitske, MS, MHA, MT(ASCP), Geisinger; Julie Hess, AdventHealth; Terrence Dolan, MD, Regional Medical Laboratory; and Dan Ingemansen, Sanford. The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies. Here is what they said.

June 2021—Point-of-care cardiac troponin testing got a fresh look last December when an emergency medicine physician and a clinical chemist came together to talk about the use of both conventional POC troponin assays in a high-sensitivity era and high-sensitivity POC troponin testing when it becomes available.

June 2021—A case of monoclonal B-cell lymphocytosis and a tour of B- and T-cell morphologies were at the heart of a CAP20 virtual presentation on neoplastic lymphocytosis. Kyle Bradley, MD, associate professor of hematopathology and director of surgical pathology at Emory University, spoke last fall on reactive (CAP TODAY, May 2021) and neoplastic lymphocytosis, with Olga Pozdnyakova, MD, PhD, who addressed neutrophilia and monocytosis (CAP TODAY, February and March 2021). Together they took attendees through a morphology-based approach to hematopoietic neoplasms presenting with an abnormal WBC differential.

June 2021—Testing for viral infections post-transplant is an important part of care for transplant patients because of the risk for infections during immunosuppression. But viral load monitoring suffers from interlaboratory variability for several reasons, and while the problem is greater at higher viral loads, the interlaboratory variability is also present at lower viral loads. Steve Miller, MD, PhD, of the University of California San Francisco, and Joseph Yao, MD, of Mayo Clinic in Rochester, reported the monitoring difficulties, solutions, and new directions last fall in a CAP TODAY webinar made possible by a special educational grant from Roche.

June 2021—Pause and restart, or rethink and reorient? That’s the question CAP TODAY publisher Bob McGonnagle put to instrument vendors and James Faix, MD, and David Grenache, PhD, D(ABCC), about COVID and core labs and the instruments in those labs. What impact the pandemic had on them and their customers was a topic of discussion when they met on an April 27 call during which they talked, too, about antibody testing and the proliferation of SARS-CoV-2 testing labs during the pandemic. What follows is part of their conversation. The rest, on IT and the staffing shortage, will be published in July, as will our guide to chemistry and immunoassay analyzers for mid- to high-volume labs.

June 2021—Several CAP fellows have reached out to me recently about a topic many find controversial: whether pathologists should unionize. Some of this interest stems from concerns about employment models and how pathologists are treated in various situations. Some of it comes from concerns that pathologists are not being compensated appropriately for the risks and responsibilities they bear daily. The COVID-19 pandemic has also fueled increased interest in unionizing among many types of health care workers. According to the U.S. Bureau of Labor Statistics, people who work in health care and social assistance are a little less likely to belong to unions than people in other fields. In 2020, 7.1 percent of workers employed in health care and social assistance were members of unions, compared with 10.8 percent for people in all industries. But the pandemic has led to an uptick in unionizing interest for many in the health care field, from nurses and respiratory therapists to many other providers as well as physicians. My great-grandfather was instrumental in bringing the United Mine Workers of America to the coal mines in Appalachia at a time when that was one of the most dangerous jobs in the country. Many miners were paid by the number of tons of coal they dug. The more they dug, the higher the pay.

June 2021—Adverse events reported following administration of the ChAdOx1 nCoV-19 AstraZeneca vaccine were similar to those reported for the Johnson & Johnson/Janssen COVID-19 vaccine. The latter was paused in the United States in April due to concerns about thrombocytopenia, cerebral venous thrombosis, and a heparin-induced thrombocytopenia (HIT)-like syndrome that was a rare occurrence post-vaccination in women under the age of 60.

June 2021—Two etiopathogenic types of vulvar squamous cell carcinoma have been described: human papillomavirus associated and HPV independent. HPV-associated vulvar squamous cell carcinoma (VSCC) develops from the precursor high-grade squamous intraepithelial lesions (HSILs).

June 2021—In myeloid malignancies, identification of genetic abnormalities informs diagnostic classification, aids risk stratification, and often predicts response to clinical therapy. Multiple methodologies generally are necessary to detect these abnormalities given the diversity of genetic occurrences, which can range from single-nucleotide variants to chromosomal translocations.

June 2021
Q. If an exfoliative cytology specimen (for example, pleural fluid) is received fresh, how long can it stay refrigerated before it needs to be placed in formalin fixative for cell block preparation? That is, what is the recommended cold ischemic time? Read answer.
Q. Are two levels of a control required for a manual reticulocyte count? Read answer.
Q. What are the requirements for obtaining emergency use authorization versus 510(k) clearance? Read answer.
Q. Are the PCR assays for SARS-CoV-2 from most manufacturers quantitative? Read answer.
Q. Is there a best specimen type to use for SARS-CoV-2 molecular testing? Read answer.
Q. What is the primary test type used to detect SARS-CoV-2? Read answer.
Q. I know that a molecular test detects nucleic acid and an antigen test detects viral protein, but how do they compare for clinical use and which is better? Read answer.

June 2021—ROI is the holy grail of pathology laboratories purchasing laboratory information systems and analyzers. The abbreviation stands for “return on investment,” but it should also mean “rarely obtained information,” jokes health care consultant Dennis Winsten.

June 2021—The Food and Drug Administration on March 30 allowed the use of the Binx Health IO CT/NG assay in physician offices, community-based clinics, urgent care settings, outpatient health care facilities, and other patient care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.