May 2021

May 2021—Forget about who’s buried in Grant’s Tomb (though for the record it’s Grant, his wife, and their dog). For laboratories, the deceptively simple question now under scrutiny is, What is estimated GFR? It is indeed an estimate, for starters—an approximation of glomerular filtration rate, which in turn is a physiological parameter that’s actually difficult to measure, says Greg Miller, PhD. Even so-called measured GFR values are not very precise in individual patients. It’s been carried along by several equations over the decades: Cockcroft-Gault, MDRD, and CKD-EPI, all of which (to the consternation of some) are still in use. It guides clinical care, including referrals to specialists and placement on kidney transplant lists, as well as dosing of medications such as metformin. Some call it a workhorse. But estimated GFR (eGFR) has also long been saddled with a race-based component, a coefficient that adjusts for better kidney function for Black patients compared with other patients.

May 2021—In the best of times, the health care industry has been the one most targeted by cyberattacks in the past decade. The pandemic has made health care an even more inviting mark, increasing the urgency of adopting effective cybersecurity measures.

May 2021—How to distinguish “reactive” and “nonreactive” benign lymphocytosis from malignant lymphocytosis, and between benign and malignant large granular lymphocytosis, is how Kyle Bradley, MD, of Emory University, opened his talk in a CAP20 virtual session last fall.

May 2021—Most of the time, bloodstream infection antimicrobial resistance results achieved with blood culture molecular ID panels will be accurate. When and why they might not be was the focus of an AMP 2020 virtual session. “I don’t want to lead anyone to believe that these are not good, accurate, and important types of tests,” Richard E. Davis, PhD, D(ABMM), MLS(ASCP)CM, said of the panels.

May 2021—How variant testing is being handled and how labs should respond to clinicians’ requests for the results was a topic of discussion when Compass Group members met April 6 with CAP TODAY publisher Bob McGonnagle for their monthly roundtable on COVID-19. The group’s members provided a follow-up on post-vaccination infections and reports on pre-procedure testing, and their thoughts on whether the focus has shifted away from testing amid the press to vaccinate. Until it’s known whether the U.S. can keep pace with vaccination alone, “it’s a mistake to take our eye off of what testing can offer, especially in terms of variant detection,” said Sterling Bennett, MD, MS, of Intermountain Healthcare.

May 2021—When it comes to next-generation sequencing, don’t count out community hospital labs, especially as black-box solutions come on the market. That’s the hope of members of an International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group that aims to help clinical labs develop in-house NGS programs. Large-scale genomic testing won’t be necessary or practical at the community hospital level. But hospital-based genomic testing programs should set out to meet the NCCN guideline targets and provide testing for which a wide range of sample input and quality can be accepted, says Robyn Sussman, PhD, a member of the IFCC working group and molecular development assistant director, Penn Precision and Computational Diagnostics, University of Pennsylvania Perelman School of Medicine.

May 2021—Next-generation sequencing analysis and interpretation, as well as reimbursement, were some of what CAP TODAY publisher Bob McGonnagle asked Illumina and Thermo Fisher executives and Jeremy Segal, MD, PhD, about when they gathered on a March 24 call. McGonnagle asked, too, about variants of unknown significance and for views on what lies ahead for NGS. “Circulating tumor DNA analysis is starting to move wholesale into the academic setting,” along with other applications, says Dr. Segal, of the University of Chicago.

May 2021—As COVID-19 restrictions ease, many laboratories are ramping up for biennial CAP inspections. Some of these inspections were delayed due to COVID restrictions and others were performed virtually and now must complete the statutory requirement of an on-site inspection. To add to the mix, the CAP published its 2020 checklist edition earlier than usual because of its impending reapplication with the CMS for deeming authority as an accrediting organization under CLIA. Together, these have made the 2021 inspection process appear unusually daunting. While no laboratory is immune to inspection anxiety, it does help to arm oneself with the knowledge gathered from the collective experiences of peers and colleagues across the country. Knowing what the common inspection pitfalls are can bring us a step closer to the “utopia” of a flawless inspection.

May 2021—The first recommended reading article consists of evidence-based guidelines for the primary diagnosis and classification of lymphoma, formulated by an expert panel convened by the CAP and the American Society for Clinical Pathology and American Society of Hematology. A comment period was provided during which more than 900 comments were received for review.

May 2021—During the past several years, significant changes have occurred in the approach to the diagnosis and follow-up of patients with breast cancer. The scattered and fragmented breast health services have been replaced by patient-centered clinical breast units and rapid assessment breast clinics all over the world.Pioneered and implemented in European countries, rapid assessment breast clinics are designed to effectively assess symptomatic women with palpable breast lesions by fine-needle aspiration biopsy (FNAB).

May 2021—Since the $1.9 trillion American Rescue Plan was signed into law in March, pathologists have been both excited and confused about its ramifications for our community. I’ve heard from many of my colleagues who expect more money to flow to their labs, and that may not necessarily be the case. The lab I run has not seen this new funding directly. Congress has made significant investments to support diagnostic testing in this bill and others enacted over the past year. The CAP is grateful for the support and recognizes that if we don’t receive funds directly, we will find funds flowing indirectly to our laboratories in one form or another. For example, Congress has ensured the necessary tests for COVID-19 that our laboratories run will be covered. This includes the tests for the uninsured. The CAP was instrumental in achieving big wins for us in this bill —but there were also places where we didn’t win. I’d like to review some of the most important elements to help all CAP members understand what to expect for your laboratories.

May 2021—Hepatitis C virus and HIV continue to be major causes of disease worldwide, and a delay in diagnosis is associated with an increase in mortality and a higher probability of viral transmission.

May 2021—Secondary involvement of the uterine cervix by nongynecologic neoplasms is rare, accounting for less than two percent of metastases to the gynecologic tract. The authors conducted a study to analyze the clinicopathologic features of cervical involvement by nongynecologic malignancies.

May 2021—As whole slide imaging has matured, pathologists have been focusing on the use of artificial intelligence algorithms. At the same time, the need to develop computer-assisted diagnostic tools to evaluate prostate core needle biopsies has intensified with the dramatic increase in the number of prostate cancer cases.

May 2021—Autoinflammatory and rheumatologic disorders in adults often present with overlapping clinical features and are challenging to treat. A genotype-first approach has been helpful to guide proper clinical management in other analogous disease settings. The authors conducted a study in which they analyzed the exome/genome sequencing data of peripheral blood cells from two large cohorts: 1,477 people who had undiagnosed recurrent fevers or systemic inflammation, or both, and 1,083 people affected by atypical, unclassified disorders who were identified through the National Institutes of Health Undiagnosed Diseases Program. Recurrent novel missense mutations affecting the methionine-41 codon of the X-linked gene UBA1, which codes for a major E1 enzyme that initiates ubiquitylation, were identified in three men. These UBA1 mutations were confirmed as somatic because they were not found in the matched fibroblasts of the affected individuals and their family members.

Q. I am part of a two-pathologist practice in a rural community hospital of 110 beds. We have been asked more frequently lately to evaluate liver and kidney biopsies for organ transplantation. We are hesitant to evaluate these biopsies for transplantation purposes due to frozen section artifacts and because we send all of our kidney biopsies performed by local nephrologists to a reference laboratory and do not evaluate kidney biopsies. It seems that regardless of what we say about the biopsies, the surgeons transplant the organs. We believe it is out of our scope of practice to evaluate liver and kidney biopsies for organ transplantation. What do you think? Read answer. Q. What is the minimum and maximum formalin fixation time for cytology specimens for optimal immunohistochemical and nucleic-acid–based molecular testing? Read answer.

May 2021–Laboratory information systems contain a wealth of diagnostic patient case data, but accessing it promptly can be difficult if not impossible—without a workaround, that is.

May 2021—In an April 21 blog post, the Association for Molecular Pathology advised against routine use of SARS-CoV-2 PCR cycle threshold values to inform clinical decisions.