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Clinical pathology selected abstracts

February 2024—Patients receiving a pathology report may have many outstanding questions that can cause anxiety and confusion. The 21st Century Cures Act has increased patients’ access to pathology reports via delivery to patient portals. However, reports sent without further explanation can exacerbate the anxiety and confusion. Many health care institutions are creating new communication methods to help patients interpret these reports and develop a better understanding of their health status. One such approach is the pathology explanation clinic (PEC), which is an interactive visit between patients and pathologists to discuss the pathology report and review the patient’s slides.

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Anatomic pathology selected abstracts

February 2024—The gold standard for prostate cancer diagnosis is the pathological examination of prostate biopsy tissue by light microscopy. The application of artificial intelligence (AI) to digitized whole slide images (WSIs) can aid pathologists in cancer diagnosis, but robust, diverse evidence in a simulated clinical setting is lacking. The authors conducted a study to compare the diagnostic accuracy of pathologists who read WSIs of prostatic biopsy specimens with and without AI assistance. Eighteen pathologists, two of whom were genitourinary subspecialists, evaluated 610 prostate needle core biopsy WSIs prepared at 218 institutions, with the option for deferral. Two evaluations were performed sequentially for each WSI: the first without assistance and the second, conducted immediately thereafter, aided by Paige Prostate (Paige, New York City).

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Molecular pathology selected abstracts

February 2024—Precision cancer medicine relies heavily on understanding the genomic landscape of tumors. Prior comparisons between African and European ancestry, though based on limited data, have indicated distinct differences in the landscape of cancer driver alterations between these populations. Whether these discrepancies are mediated by genetic variants or environmental influences is still unclear. Accurately characterizing ancestry-associated genomic alterations is essential to not only improving genomic diagnostic testing but also to developing targeted therapies, biomarkers, and personalized cancer care for diverse populations. The authors conducted a study that leveraged two large genomic cohorts to investigate the relationship between genomic alterations and African ancestry in six common cancers: prostate, pancreas, ovary, nonsmall cell lung cancer (NSCLC), colorectal, and breast.

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Q&A column

Feburary 2024 Q. In a case of suspected drug-related death, how specific can an autopsy be in identifying the drug(s) that might have caused the person’s death and the amount of drugs present? For example, can a toxicology report say a person’s death was caused by a fake oxycodone pill containing fentanyl? Read answer. Q. A nephrology patient who has been treated with vitamin D2 for several years contacted our laboratory to find out why their 25-hydroxyvitamin D level of 60 ng/mL is now considered elevated when before it was within the normal range. How can we explain this? Read answer.

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Newsbytes

Dr. Glassy

February 2024—The key to using ChatGPT and other large language models effectively in pathology is understanding not only what they are designed to do but, just as importantly, what they are not designed to do, says Eric Glassy, MD, medical director at Affiliated Pathologists Medical Group, Rancho Dominguez, Calif., and past chair of the CAP Information Technology Leadership Committee.

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Clinical pathology selected abstracts

January 2024—People respond differently to SARS-CoV-2 infection, with some having a very severe clinical course and sequelae while others recover quickly. Several research studies have used laboratory data to identify patient populations most at risk for severe outcome from COVID-19. However, many of these studies were conducted in China and did not represent the demographics of the U.S. population. Among the drawbacks of these studies were that most analyzed variance between two patient groups, yet statistical differences don’t always correlate with clinically useful predictions. Furthermore, these studies used data from throughout patients’ disease course, and clinicians would like to identify patients at risk during their initial interaction.

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Anatomic pathology selected abstracts

January 2024—Diffuse parenchymal lung disease is a well-recognized complication of systemic connective tissue disease but rarely arises in patients with psoriasis or psoriatic arthritis, which are poorly understood. Therefore, the authors conducted a study to characterize diffuse parenchymal lung disease (DPLD) associated with psoriasis or psoriatic arthritis, with or without prior immunomodulation. Their pathology consultation files were searched for patients having psoriasis or psoriatic arthritis and DPLD. After excluding cases with active infection or smoking-related DPLD only, 44 patients (22 of whom were women; median age, 60 years; range, 23–81 years) were enrolled in the study. Clinical history and pathology slides were reviewed.

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Q&A column

January 2024 Q. Can a person who has a bachelor of science degree in health care administration sign off on competency assessments? Read answer. Q. Our laboratory uses a total protein assay from Beckman Coulter that has an analytical measurement range of 3–12 g/dL for serum determinations. The assay sensitivity states 1 g/dL of total protein. Can we loop sensitivity into our AMR and make our reporting range 1–12 g/dL? Will this make our assay a laboratory-developed test? Quite often our clinicians need assays reported to 1 g/dL, since they need to calculate the ratio of total protein serum to body fluid as per Light’s criteria. If we report to 1 g/dL, we have to loop sensitivity into our AMR. Read answer.

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Newsbytes

January 2024—When the medical microbiology laboratory at Yale-New Haven Hospital makes operational changes, it uses data analytics to monitor their impact. Yet the process of implementing laboratory analytics can be challenging.

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Put It on the Board

January 2024—The Association for Molecular Pathology on Dec. 14 published a joint report on what to consider for a slice testing strategy for diagnostics, including gene selection, analytic performance, coverage, quality, and interpretation. Slice testing is the practice of bioinformatically selecting a subset of genes from exome or genome sequencing assays.

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From the President’s Desk

December 2023—About five years ago, when I was serving in my first term on the CAP Board of Governors, I attended a House of Delegates meeting where we had a candidate forum with several people on stage competing for just a few Board slots. Of the half-dozen or so people, only one or two were women and none was a minority. That’s when one delegate stood up and, with a single question, altered the course of our entire organization: “When will the CAP have candidates for higher office who look like the CAP membership?”

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Anatomic pathology selected abstracts

December 2023—Cytomegalovirus hepatitis in allograft livers is a significant infectious complication for which the histology historically has been described as overlapping that of acute cellular rejection, a diagnosis that compels a different treatment regimen. The authors conducted a study to update the clinicopathologic features of cytomegalovirus (CMV) hepatitis and explore its clinical and histologic relationship with acute cellular rejection (ACR). They performed a retrospective analysis of 26 patients, across four institutions, who were diagnosed with CMV hepatitis, assessing clinical, histologic, and IHC features. Patients were predominantly CMV donor positive/recipient negative (D+/R-; n=9 of 15) and received a diagnosis of CMV hepatitis at a mean age of 52 years (standard deviation [SD], 17 years) and at a mean interval of 184 days (SD, 165 days) from transplantation. Mean CMV viral load at diagnosis was 241,000 IU/mL (SD, 516 000 IU/mL), and liver biochemical enzymes were elevated (mean alanine aminotransferase, 212 U/L [SD, 180 U/L]; mean aspartate aminotransferase, 188 U/L [SD, 151 U/L]; and mean alkaline phosphatase, 222 U/L [SD, 153 U/L]).

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Clinical pathology selected abstracts

December 2023—Efforts to develop biomarkers that help predict risk factors for preeclampsia/eclampsia and to better understand the trends and implications related to new-onset hypertensive disorders in pregnancy have grown. New-onset hypertension arising during pregnancy (gestational hypertension and preeclampsia/eclampsia) is associated with coronary heart disease, heart failure, stroke, and other cardiovascular-related mortality. Hypertensive disorders of pregnancy have grown into major public health problems that contribute to maternal morbidity, mortality, and future risk of cardiovascular disease. The authors conducted a study to describe contemporary trends in new-onset hypertensive disorders of pregnancy in the United States. They conducted a serial cross-sectional analysis of 51,685,525 live births to women aged 15 to 44 years, from 2007 to 2019, using the Centers for Disease Control and Prevention’s natality database.

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Molecular pathology selected abstracts

December 2023—Immune checkpoint blockade therapy has dramatically altered treatment options for a variety of cancers. A high tumor mutation burden (TMB) is considered one of the strongest predictors of immune checkpoint blockade response. DNA mismatch repair deficiency (MMRd) is associated with a high TMB, and many tumors associated with MMRd have shown excellent response to immunotherapy. However, most MMRd tumors do not show durable response to treatment with immune checkpoint blockade (ICB). Intratumor heterogeneity may further mediate response to ICB therapy.

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Q&A column

December 2023 Q. When using a sodium citrate blue-top tube due to platelet clumping, should the sample be kept warm, and does it have to be run within a certain time frame? Read answer. Q. Does the CAP require instrument-to-instrument comparability studies at least twice a year for waived point-of-care testing instruments, such as glucose meters, or nonwaived instruments, such as critical care analyzers? Are we required to perform a linearity study twice a year on all waived and nonwaived POC testing instruments? Read answer.

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Clinical pathology selected abstracts

November 2023—Among the many reasons unnecessary laboratory tests are ordered in a hospital are preselected orders on order sets, clinician habits, and trainee concerns. Laboratory tests are among the highest volume procedures performed in inpatient hospital care. Excessive use of these tests can lead to patient discomfort as a result of unnecessary phlebotomy and contribute to iatrogenic anemia and increased risk of bloodstream infections. It can also contribute to the rising cost of medical care. Many laboratory stewardship programs have been developed to improve how clinicians order and use lab tests.

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Anatomic pathology selected abstracts

November 2023—Claudin-4 is a sensitive and specific marker for carcinoma in effusion cytology. The authors examined the diagnostic use of claudin-4 versus MOC-31 and Ber-EP4 by comparing their sensitivity, specificity, positive predictive value, and negative predictive value in differentiating carcinoma from mesothelioma and benign/mesothelial hyperplasia in effusion specimens. They conducted a retrospective study on a cohort of 229 cytology specimens, including 211 effusion fluid and 18 fine-needle aspiration specimens. The cytologic categories included 134 carcinoma, 28 mesothelioma, 46 indefinite (suspicious and atypical), and 21 benign.

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Molecular pathology selected abstracts

November 2023—Dilated cardiomyopathy is characterized by dilation and weakening of one or both ventricles combined with impaired contractility. Although several external etiologies are associated with dilated cardiomyopathy (DCM), a familial form (comprising about half the known cases of DCM) has symptoms that tend to arise in mid-adulthood. Despite the genetic nature of the familial form, little is known about the genetic profile of the disease. Black patients have an increased familial risk of DCM and often have a worse prognosis. The authors conducted a study in which they used genomic ancestry to compare the rare variant genetic architecture of DCM within a diverse patient population.

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Q&A column

November 2023 Q. A molecular laboratory received an order from an oncologist for next-generation sequencing testing. The patient’s tissue sample was in the custody of a different laboratory, which has a policy requiring patient consent to release materials for reference lab testing. The oncologist planned to obtain consent from the patient during a scheduled appointment, but the patient’s condition unexpectedly worsened and the patient could no longer travel for the appointment. Neither the custodial laboratory nor the treating health system have mechanisms for electronic consent. As a result of the lack of options for obtaining consent remotely and the custodial laboratory’s stringent consent policy, potentially life-altering NGS testing was delayed for more than a month. Is this restrictive approach to releasing patient material for reference laboratory testing supported by CAP guidelines? Read answer. Q. Is it acceptable to perform weak D testing on a newborn who has an RhD-negative blood type and a positive direct antiglobulin test? We know a positive DAT might cause false-positive results on an Rh test, but can it cause false-negative results? Read answer.

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Newsbytes

November 2023—“The best way to have a good idea is to have a lot of ideas,” according to Linus Pauling, a chemist and chemical engineer who, among other accomplishments, helped create a form of synthetic plasma. But when there is no structure in place to nurture those ideas, the result can be “a lot of people focused in a lot of different directions,” says Sky Soom, innovation analyst with Sonora Quest Laboratories.

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Put It on the Board

November 2023—Roche announced last month the U.S. launch of its Cobas Connection Modules (CCM) Vertical, the elevator and overhead components of its fully automated and modular CCM system to help low-, mid-, and high-volume laboratories optimize space, productivity, and patient care.

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From the President’s Desk

October 2023—In my long career, I’ve met a lot of pathologists. The military pathologist. The private practice pathologist who drives 75 miles each way to serve patients at a small rural hospital. The academic pathologist frantically writing a research grant proposal after a full day of clinical service. The lab director struggling to keep up with a rapidly growing specimen volume.

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Clinical pathology selected abstracts

October 2023—Several large randomized controlled trials have shown the safety of tolerating hemoglobin levels as low as 7 g/dL in critically ill hemodynamically stable children. These trials have led to recent guidelines advocating for restrictive transfusion therapy, which is significantly changing practices in pediatric critical care.

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Anatomic pathology selected abstracts

October 2023—Special AT-rich sequence-binding protein 2, or SATB2, induces local chromatin loops to facilitate transcription. SATB2 immunostaining is commonly used as a marker for colorectal adenocarcinoma and osteosarcoma. The authors conducted a study to better understand the prevalence and diagnostic value of SATB2 expression in cancer by analyzing a comprehensive set of human tumors. SATB2 expression was analyzed in 15,012 tissue samples from 120 tumor types and subtypes and 608 samples from 76 nonneoplastic tissue types using IHC in a tissue microarray format. SATB2 positivity was found in 89 of the 120 (74 percent) tumor types—59 of the 120 (49 percent) had at least one moderately positive tumor and 38 of the 120 (32 percent) had at least one strongly positive tumor.

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Molecular pathology selected abstracts

October 2023—Ovarian cancer is the eighth most common cancer in women. There are several histological types of ovarian neoplasms, and all rank among the deadliest gynecological cancers. However, those with homologous recombination deficiency (HRD) may benefit from a recently discovered category of drugs, called poly ADP-ribose polymerase inhibitors (PARPi). The homologous recombination repair pathway, which is responsible for repairing double-strand DNA damage, involves several genes, including BRCA1, BRCA2, and ATM. People with germline or somatic deleterious alterations of these genes are at higher risk of certain malignancies, such as ovarian, breast, prostate, and pancreatic cancers.

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Q&A column

October 2023 Q. What is the total allowable error for lupus anticoagulant testing? Read answer. Q. Our laboratory may relocate to a building five blocks from our current hospital. What kind of instrument validation or verification studies do we need to perform following a move? When should we update the address on our CLIA license and for CAP accreditation? Are we required to have a new CAP inspection before or after testing patient samples at the new location? Read answer.

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Newsbytes

Dr. Krupinski

Ocotber 2023—Health care technology companies, by and large, are eager to share product metrics—that is, standalone product performance—with potential pathology lab clients but less eager to share how those technologies may impact laboratory workflow and decision-making.

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Put It on the Board

October 2023—The Food and Drug Administration has granted clearance to Streck’s MDx-Chex for BC-GP and MDx-Chex for BC-GN for use in diagnostic procedures. They are quality controls designed to verify the performance of the Luminex Verigene Blood Culture Gram-Positive (BC-GP) and Gram-Negative (BC-GN) tests for bloodstream infection and sepsis.

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Clinical pathology selected abstracts

September 2023—Approximately 30 percent of U.S. employees report that they have been bullied in the workplace, and these numbers are even higher for remote workers. Bullying is defined as any act or situation in which someone is subjected to recurrent, systematic, serious negative or hostile behavior and long-lasting acts designed to oppress or abuse another person. This behavior may include belittling, humiliating, personally attacking, verbally criticizing, or intentionally excluding a coworker. Bullying can harm both the target of the attack and the organization that employs the bully and the targeted person. The potential negative effects on an organization can be high staff turnover, a decrease in employee performance and productivity, and an increase in errors and medical mistakes.

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Anatomic pathology selected abstracts

September 2023—Understanding of the pathologic and molecular features of endometrial cancer has advanced measurably since the FIGO (International Federation of Gynecology and Obstetrics) staging system was updated in 2009. New treatments, results of clinical trials, and prognostic survival data that correlate with pathologic and surgical findings have been reported. Therefore, the FIGO Committee on Women’s Cancer determined that changes to the FIGO system were necessary. The goals of the revised staging system are to further clarify the diverse biologic nature of endometrial carcinomas with differing prognostic outcomes, better define the prognostic groups, and create substages that yield more appropriate surgical, radiation, and systemic therapies. The cancer committee developed a subcommittee on endometrial cancer staging in October 2021, of which the authors are members.

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Molecular pathology selected abstracts

September 2023—Neurodegenerative diseases are a broad group of disorders characterized by progressive loss of nerve cells in the central or peripheral nervous system. These diseases are often chronic and incurable, with symptoms ranging from cognitive decline to motor or sensory dysfunction. There are many types of neurodegenerative diseases, with various underlying etiologies. One group of diseases, the synucleinopathies, are associated with the misfolding and aggregation of the protein α-synuclein. This group includes disease entities such as Parkinson disease, dementia with Lewy bodies, and multiple-system atrophy.

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Q&A column

September 2023 Q. Some recent clinical guidelines recommend lower therapeutic and toxic limits for digoxin than those provided in assay package inserts. What therapeutic ranges and toxic thresholds should laboratories use? Read answer. Q. One of our providers noticed that two laboratories—one in New York and one in Florida—reported very different thyroid-stimulating hormone values for a patient and called our laboratory to determine which was correct. How should we handle such situations? Read answer.

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Newsbytes

September 2023—The musician Frank Zappa said, “One size does not fit all,” a declaration that counters the claims of many clothing manufacturers and holds true for a variety of products, including, one could argue, digital scanners.

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Put It on the Board

September 2023—A wrist-worn high-sensitivity cardiac troponin I monitor was one of the wearable devices and health monitors highlighted in a session on emerging technologies for point-of-care testing at the Association for Diagnostics and Laboratory Medicine meeting in July.

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Letters

September 2023—I read with interest “In anatomic pathology labs, a balancing act” (August 2023). Some of the roundtable participants highlighted an area of next-generation-sequencing–based diagnostics that is a blind spot for pathologists, molecular biology tool manufacturers, and laboratory information system vendors—namely how to reduce the fractional cost of performing NGS-based analysis. On the topic of gene panels, the participants offered that the workflows are complex, reimbursement is relatively low, and startup costs are high—all true statements. However, I was struck that they evaluated the cost structure only in the setting of tissue oncology, with the implication being that the fully loaded cost of the diagnostic must be borne by the degree and level of oncology-based sequencing.

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From the President’s Desk

August 2023—The benefit of the doubt: a risk worth taking in health care? Many of us work in practices, hospitals, or departments that are short-staffed. In the aftermath of the pandemic, it is harder now than ever to find qualified people, from pathologists to clinical laboratory scientists to phlebotomists. Those of us who still work in laboratories are feeling the stress of carrying an extraordinary load.

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Clinical pathology selected abstracts

August 2023—Burnout has been reported to affect as many as 44 percent of physicians. It is listed in the International Classification of Diseases 11th Revision (ICD-11) and has been attributed to chronic workplace stress, emotional exhaustion, depersonalization, and a low sense of personal accomplishment. A social psychologist created the Maslach Burnout Inventory (MBI) tool to measure degrees of burnout. The 2018 Canadian Medical Association Physician Health Survey of 3,000 members found an overall burnout rate of 30 percent, and 28 percent of pathologists who responded to that survey indicated they were burned out. Physician burnout can have a significant negative impact on patient care, including on the amount of medical errors. It has been estimated that physician burnout costs the Canadian health care system CAD $185 million due to early retirement and CAD $27.9 million due to reduced professional work effort.

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Anatomic pathology selected abstracts

August 2023—Gastric foveolar-type adenoma is a rare benign neoplasm that occurs sporadically or presents in patients with familial adenomatous polyposis. The molecular features of foveolar-type adenoma (FA) and the relationship between sporadic and syndromic lesions remain unclear. The authors conducted a study in which they performed clinicopathological, immunohistochemical, and genetic analyses of 18 sporadic and 30 familial adenomatous polyposis (FAP)-associated FAs. The majority of sporadic and FAP-associated FAs were located in the upper or middle third of the stomach on a background of fundic gland mucosa. Most lesions were low grade, but three had a high-grade component.

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Molecular pathology selected abstracts

Augstus 2023—Atypical hemolytic uremic syndrome is a rare, potentially life-threatening thrombotic microangiopathy. The disorder causes tiny blood clots to form in blood vessels and results in organ damage. Clinical findings in atypical hemolytic uremic syndrome (aHUS) include hemolytic anemia, low platelet count, and acute kidney failure. In many cases, HUS is caused by Shiga toxin-producing E. coli, other infections, or certain medications, or it can result from other health conditions. The label “atypical” is used to delineate hemolytic uremic syndrome that is not due to any of these common causes.

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Newsbytes

August 2023—How often do pathology departments underbill insurance companies for their services? And how much money do they lose because of underbilling mistakes? A prototype dashboard at Dartmouth Hitchcock Medical Center aims to answer those questions by using natural-language processing and machine-learning algorithms to flag pathology cases that are underbilled.

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Put It on the Board

August 2023—The Association for Diagnostics and Laboratory Medicine (formerly AACC) and the American Diabetes Association last month issued guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus (Sacks DB, et al. Clin Chem. 2023;69​[8]:808–868).

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From the President’s Desk

July 2023—About a year ago, I used this column to talk about the CAP’s efforts to prioritize innovation and to create more pathways for staff and members to help keep us on the cutting edge. I know “innovation” can seem like a meaningless buzzword that organizations throw around without putting anything substantial behind it, so I wanted to come back to the topic and show that we really are taking it seriously at the CAP.

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Clinical pathology selected abstracts

July 2023—Hemolytic disease of the fetus and newborn is caused by maternal immunoglobulin G crossing the placenta and binding to fetal RBC antigens. In severe cases, it results in fetal or neonatal anemia, edema, hepatosplenomegaly, and death. In China, antibodies to the ABO blood group system are the most common cause of hemolytic disease of the fetus and newborn (HDFN) and account for 85.3 percent of cases. This is followed by antibodies to the Rh blood group system, which account for 14.6 percent of HDFN cases. Other blood group systems, including Duffy, Kidd, and MNS, may also cause HDFN.

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Anatomic pathology selected abstracts

July 2023—High-grade appendiceal mucinous neoplasm is a relatively recent term that describes a rare epithelial neoplasm of the appendix that demonstrates pushing-type invasion but high-grade cytologic atypia. Because it has been understudied, the authors conducted a multi-institutional retrospective study to describe the clinicopathologic features of high-grade appendiceal mucinous neoplasm (HAMN). They reviewed the clinical and histologic features of 35 HAMNs and the molecular features of eight of the cases. Patients were an average of 57 years old and most commonly presented with abdominal or pelvic pain. Histologically, 57 percent of the tumors showed widespread high-grade features.

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Molecular pathology selected abstracts

July 2023—Non-muscle-invasive bladder cancer accounts for the majority of bladder tumors and is typically treated with transurethral resection of the bladder tumor followed by adjuvant intravesical Bacillus Calmette-Guérin instillations. However, the long-term effectiveness of Bacillus Calmette-Guérin (BCG) is limited, and patients with recurrent or progressive disease have lower survival rates. Understanding the genetic makeup of tumors and identifying molecular subtypes associated with BCG response could provide valuable insights that aid in developing personalized treatments. The authors conducted a study in which they performed whole-transcriptome sequencing of non-muscle-invasive bladder cancers (NMIBCs) from 132 patients who had never received BCG treatment and 44 patients whose cancer recurred after BCG treatment. Based on these patients’ results, the authors identified three unique molecular subtypes among the tumors—BRS1, 2, and 3. Patients with BRS3 showed increased epithelial-to-mesenchymal transition pathway activity and their tumors were enriched for mutations associated with the extracellular matrix when compared with the other two subtypes.

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Newsbytes

July 2023—The Permanente Medical Group, Oakland, Calif., has launched the Kaiser Permanente Northern California Division of Research Augmented Intelligence in Medicine and Healthcare Initiative Coordinating Center, or AIM-HI. The program will support a national research effort focused on evaluating artificial intelligence and machine-learning algorithms to enhance diagnostic decision-making in health care.

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Put It on the Board

July 2023—Roche’s Elecsys beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys Total-Tau CSF assays (tTau) have received Food and Drug Administration 510(k) clearance. They are used as a tTau/Abeta42 ratio, which will become available in the fourth quarter of this year.

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From the President’s Desk

June 2023—I embarked this year on my first international travel as president of the CAP. Due to limitations from the pandemic, I haven’t been able to do as much of this as some of my predecessors, but happily this year we seem to be finally coming out of the worst of it.  

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Clinical pathology selected abstracts

June 2023—Studies that address whether the incidence of dementia in the U.S. population is declining are inconsistent. They cannot establish conclusive trends in disease rates. Most studies are hard to interpret due to small sample sizes or use of hospital-based autopsies. Understanding trends in dementia is necessary from a public health perspective and for planning interventions. Therefore, the authors conducted a study to characterize trends in pathways underlying dementia using two U.S. cohorts focused on aging and dementia.  

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Anatomic pathology selected abstracts

June 2023—The authors conducted a study to examine whether quantitative digital pathology can derive valuable information from readily available and inexpensive H&E slides and thereby augment routine pathologic reporting of colorectal carcinoma. They applied a quantitative segmentation algorithm (QuantCRC) to 6,468 digitized H&E slides of colorectal carcinoma (CRC). Fifteen parameters from each image were recorded and tested for associations with clinicopathologic features and molecular alterations. A prognostic model was developed to predict recurrence-free survival using data from the internal cohort (n=1,928) and validated on an internal test (n=483) and external cohort (n=938). There were significant differences in QuantCRC according to stage, histologic subtype, grade, venous/lymphatic/perineural invasion, tumor budding, CD8 IHC, mismatch repair status, KRAS mutation, BRAF mutation, and CpG methylation.    

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Molecular pathology selected abstracts

June 2023—Endometriosis is defined by the presence of endometrial-like tissue outside of the uterus and can cause debilitating pelvic pain and often infertility. It has also been associated with a range of reproductive, metabolic, inflammatory, and chronic pain conditions. While it is fairly common, affecting five to 10 percent of women of reproductive age, treatment options are limited, and the precise causes of endometriosis, as well as its relationship with other conditions that cause chronic pain, remain unclear. Studies estimate that endometriosis has a heritability of approximately 50 percent. Nine genomewide association studies (GWAS) of endometriosis involving women of European and East Asian ancestry were reported prior to this study.  

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Q&A column

June 2023 Q. California Senate Bill 864 requires that fentanyl screening be included in every drug screen performed in a general acute-care hospital laboratory. The problem is there are no FDA-approved platforms for rapid screening of fentanyl. I found several for forensic use only. The only reagents I found are third-party products to run on open channels on large chemistry analyzers. This is a huge amount of work and expense for a small laboratory. Is sensitivity the stumbling block for rapid testing? How useful is a urine screen if an overdose is an immediate effect and it takes hours for fentanyl to show up in urine and then another hour to run it on a chemistry analyzer? Read answer. Q. How should a laboratory calculate analyzer throughput? Has a formula been published? Read answer.

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Newsbytes

June 2023—The time it takes to read through numerous pathology reports to find nuggets of critical information buried within narrative sections of text is tantamount to the time it takes for carbon atoms to turn into diamonds—or so it may seem to those tasked with digging for medical information.  

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From the President’s Desk

May 2023—The spring of 2003 was not an easy time for me. I was taking care of my kids, a four-year-old and an infant, while going through a divorce. I had just started a new job and felt all the stress associated with that. The upheaval in my life sometimes felt overwhelming.  

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Clinical pathology selected abstracts

May 2023—Several studies have evaluated the brain protective role of the Mediterranean-DASH (Dietary Approaches to Stop Hypertension) Intervention for Neurodegenerative Delay (MIND) diet. The studies have shown that the MIND diet can slow cognitive decline, reduce rates of cognitive impairment, and reduce Alzheimer’s and Parkinson’s disease. Because obesity is a global epidemic, there is an interest in determining if the MIND diet may also have a beneficial effect on cardiovascular disease mortality, central or general obesity, metabolic syndrome and its components, and cardiac remodeling. The authors conducted a cross-sectional study to examine the relationship between the MIND diet and other metabolic risk factors, including lipids, glycemic indicators, and mental health, in obese people. The study included 339 obese people (body mass index of 30 kg/m2 or more) who were between 20 and 50 years old and lived in Tabria or Tehran, Iran.  

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Anatomic pathology selected abstracts

May 2023—Although criteria for malignancy have been established for glomus tumors of soft tissue, no accepted criteria exist for gastroesophageal glomus tumors, which are considered to behave unpredictably. Benign and aggressive gastroesophageal glomus tumors have been shown to harbor CARMN::NOTCH2 fusions, but genetic features that predict clinical behavior have not been identified. The authors conducted a study in which they evaluated 26 gastroesophageal glomus tumors to investigate histologic and genetic features that may predict malignancy. Seventeen of the 26 (65 percent) patients were male. The median age at presentation was 54.5 years (range, 16–81 years).  

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Molecular pathology selected abstracts

May 2023—One in four children worldwide have unregistered births according to 2019 data from UNICEF. While efforts are underway to mitigate this staggering statistic by prioritizing documentation of birth, millions of people still cannot prove their date of birth. Age-assessment methods, most commonly used in forensics, have relied on bone radiography. However, more recently, chronologic age-prediction models have been developed based on knowledge of how epigenetics change with age. Epigenetics is the modification of gene expression without changing the underlying genetic code.

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Pathology informatics selected abstracts

May 2023—Computational pathology is a subspecialty of pathology that exploits computational analysis to analyze patient specimens and that often uses multiple sources of related data. Artificial intelligence systems are typically used in this subspecialty. The field of pathology is rapidly being transformed by the development of AI algorithms trained to perform diagnostic, prognostic, and predictive tasks. However, routine use of artificial intelligence in anatomic pathology remains limited, making it difficult to measure the long-term clinical impact of AI. With this issue in mind, the authors surveyed 24 subject matter experts worldwide regarding the anticipated role of AI in pathology by the year 2030.

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Q&A column

May 2023 Q. How long do blood transfusions affect mean corpuscular volume values? A patient had a red blood cell count of 2.5 × 106/μL, hemoglobin level of 7.3 g/dL, hematocrit of 22.7 percent, MCV of 90.8 fL, mean corpuscular hemoglobin of 29.2 pg/cell, and a mean corpuscular hemoglobin concentration of 32.2 g/dL. Thirteen days after transfusion, the patient’s values were an RBC of 3.61 × 106/μL, Hgb 10.7 g/dL, Hct 34.6 percent, MCV 95.8 fL, MCH 29.6 pg/cell, and MCHC 30.9 g/dL, and the analyzer flagged the Hgb as abnormal because the MCHC was low. Read answer. Q. We perform a cell count and differential for bronchoalveolar lavages. I understand the importance of a differential cell count, but is a cell count clinically significant when the bronchoalveolar volume is not standardized? Read answer.

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Newsbytes

May 2023—In 2020, when much of the world was locked down due to the pandemic, researchers at the University of Texas Medical Branch, in Galveston, began helping pharmaceutical companies evaluate the effectiveness of COVID-19 vaccines using a neutralizing antibody assay they had developed. A hot minute later (or so it seemed), some UTMB pathologists concluded that their patients might want to know if they had neutralizing SARS-CoV-2 antibodies.  

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Put It on the Board

May 2023—Kaiser Foundation Hospitals and Geisinger Health announced the launch of Risant Health and a definitive agreement to make Geisinger the first health system to join Risant Health to expand access to value-based care in more communities across the country. Upon regulatory approval, Geisinger becomes part of the new organization through acquisition.

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Letters

May 2023—As members of the CAP Transfusion, Apheresis, and Cellular Therapy Committee, we wish to offer comments to the readers of CAP TODAY in response to the article, “Case review reveals latest on overtransfusion” (March 2023). The article reported on a single publication of retrospective reviews of transfusions given in 2012–2018 in 15 community hospitals (Jadwin DF, et al. Jt Comm J Qual Patient Saf. 2023;49[1]:42–52), based on approximately 100 encounters with transfusions per institution. The retrospective character of this work as well as its applied methodology raise several important questions regarding the true value of any conclusions and their generalizability. Interpretation of the presented data requires a thorough and unbiased discussion, as some numbers are significantly out of observed ranges elsewhere. For example, by the authors’ methodology, less than 10 percent of encounters had fully appropriate RBC transfusions.  

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From the President’s Desk

April 2023—Here is a scenario for you: Your hospital administration team identifies a strategic need and establishes a new service line, perhaps in cardiology or women’s health. They speak with the relevant surgeons and specialists, gathering expert perspectives about this new service line. But only after everything else has been put in place does anyone consider how laboratory medicine will play a role. Sound familiar?  

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Clinical pathology selected abstracts

April 2023—Cancer is the second leading cause of death globally. While great progress is being made in personalized cancer treatments, early detection and diagnosis is critical to reduce mortality and improve the effectiveness of treatment. Guidelines for preventative screening are available but require a large public health intervention strategy. Having “one-stop-shop” screening for multiple cancers at one time would reduce the barriers to participating in cancer screening programs and may lead to greater numbers of screening participants. An integrated cancer prevention center (ICPC) was developed in 2006 at the Tel Aviv Medical Center, in Israel, to screen for all cancers that the U.S. Preventive Services Task Force recommends be screened, including breast, colon, cervical, lung, skin, ovarian, uterine, thyroid, testicular, oropharyngeal, and prostate cancer.  

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Anatomic pathology selected abstracts

April 2023—Kaposi sarcoma can pose diagnostic challenges in biopsy specimens. Multiple histologic variants of cutaneous Kaposi sarcoma (KS) have been described. However, the histomorphologic spectrum of gastrointestinal KS has not been systematically studied. The authors presented a large multi-institutional case series that comprehensively evaluated 46 cases of KS involving the GI tract and identified seven histomorphologic variants, some of which had not previously been described. Five of the variants—lymphangioma/lymphangiectatic like (n=17), mucosal hemorrhage/telangiectatic like (n=17), mucosal inflammation like (n=15), granulation tissue like (n=13), and mucosal prolapse like (n=4)—were inconspicuous but had unique morphologic patterns. These variants easily can be misdiagnosed or misinterpreted on routine examination if KS is not considered and if the IHC stain for human herpesvirus-8 is not utilized.  

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Molecular pathology selected abstracts

April 2023—Clonal hematopoiesis of indeterminate potential refers to the clonal expansion of hematopoietic stem cells that harbor a somatic mutation in people who do not exhibit hematological symptoms. This phenomenon is common in the elderly and associated with an increased risk of hematological malignancies, cardiovascular disease, infection, and all-cause mortality. Several somatic alterations are frequently detected in clonal hematopoiesis of indeterminate potential (CHIP), but the medical community’s understanding of the underlying genetic predisposition to CHIP is limited. The authors conducted a large-scale exome-sequencing study involving more than 600,000 people to characterize CHIP status and discover rare somatic variants and possible predisposing germline alterations. The prevalence of CHIP was 15 percent by 75 years of age, and the affected individuals were more likely to be heavy smokers, in agreement with previous studies.  

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Q&A column

April 2023 Q. Which criteria should be used to interpret mixing studies, not only for lupus anticoagulants but also for other inhibitors? Read answer. Q. How does the CAP checklist requirement COM.30840 Pipette Carryover relate to blood bank automation? Are there CAP guidelines that address pipette carryover relative to such systems? Read answer. Q. Our laboratory is assessing criteria for determining quantity not sufficient for a microscopic urinalysis. We were using an automated instrument but have gone back to manual microscopy for reasons beyond our control. While most textbooks state that 10 to 15 mL is the desired amount of sample for testing, it appears that many laboratories require smaller amounts. Can you provide guidance? Read answer.

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Newsbytes

April 2023—At the medical center of the University of Medicine and Pharmacy at Ho Chi Minh City, patients are not screened for bladder cancer using urine cytology because the pathology department does not have the capability for such screening. But that may soon change, thanks to an organization focused on using digital pathology to increase the availability of pathology education resources in developing countries.

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Letters

April 2023—There have been several recent articles in CAP TODAY regarding the use of whole blood and prehospital transfusion. The general tenor of the reporting has supported these novel practices. We would like to suggest an alternative perspective.  

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From the President’s Desk

March 2023—If you’ve read my prior columns, you know I am a strong advocate for pathologists stepping into leadership roles both within and outside the clinical laboratory. Our training gives us unique advantages as we serve in executive positions in health care, where our holistic view of medicine allows us to engage substantively on a broad range of issues. But what does that look like in the real world? I took on my first role as a hospital’s chief medical officer nearly two years ago and in some cases I’ve been surprised by how my day-to-day responsibilities differ from what I expected. Some of those surprises have been pleasant and some have not.  

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Clinical pathology selected abstracts

March 2023—Coagulation screening prior to surgery for patients without a history of a bleeding disorder is controversial. Studies have recommended routine screening of prothrombin time/International Normalized Ratio (PT/INR) and activated partial thromboplastin time (aPTT) to reduce the risk of perioperative and postoperative hemorrhage. Other studies have questioned the value of coagulation screening tests, such as INR, aPTT, and platelet count, because it is rare to detect an abnormal value in patients undergoing elective surgeries. Many professional society guidelines, such as those of the American Society of Anesthesiologists and British Committee for Standards in Hematology, advise against routine perioperative coagulation screening prior to surgery for patients who do not have a clinical history of abnormal bleeding, medical history of comorbidity, or bleeding disorders. The authors conducted a study in which they examined the association between abnormal coagulation profile and risk of transfusion following common elective surgery in patients who did not have bleeding disorders. They used the National Surgical Quality Improvement Program (NSQIP) database for their retrospective cohort study, which focused on adult patients across multiple disciplines who underwent common surgical procedures between 2004 and 2018.  

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Anatomic pathology selected abstracts

March 2023—Prognostic stratification of patients with surgically resected invasive pulmonary adenocarcinoma must be improved. The authors conducted a study to evaluate the prognostic value of complex glandular patterns (CGPs) in patients with resected stage I through IV lung adenocarcinoma. The presence of CGPs as a minor to predominant component was tested for association with overall survival (n=676) and relapse-free survival (n=463) after surgery. CGPs were observed in 284 (42 percent) tumors. Cribriform and fused gland were the predominant patterns in 35 and 37 cases, respectively. The presence of a cribriform pattern was associated with worse relapse-free but not overall survival.  

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Molecular pathology selected abstracts

March 2023—The Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists published a formalized somatic variant classification system in 2017. The tiered system stratifies variants based on clinical importance, taking into account how variants affect cancer diagnosis, prognosis, or treatment strategies. Somatic variants with strong clinical significance, including those that are associated with FDA-approved therapies or included in professional guidelines, are tier one; variants with potential clinical significance are tier two; variants of unknown significance are tier three; and benign variants are tier four. The authors, members of the AMP Variant Interpretation Across Testing Laboratories Working Group, assessed how laboratories are using the AMP/ASCO/CAP guidelines and whether there is good concordance among laboratories in applying the guidelines to variant interpretation. A somatic variant interpretation challenge was sent to participating laboratories.  

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Pathology informatics selected abstracts

March 2023—Whole slide imaging is increasingly being adopted by pathology laboratories worldwide. In 2013, the College of American Pathologists published guidelines on validating whole slide imaging (WSI) for diagnostic purposes. The CAP updated the recommendations in 2021. The guidelines include three strong recommendations and nine good-practice statements. The purpose of the validation guidelines is to ensure that a WSI system performs as intended in a particular clinical environment before it is used in patient care. In other words, the process is intended to make sure pathologists can render accurate diagnoses with WSI that are at least comparable to those provided via traditional light microscopy and that there are no interfering artifacts or technological risks to patient safety.  

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Q&A column

March 2023 Q. What is the best method to quantify ketones in serum? Can urine strips be used to detect ketones in serum? Read answer. Q. Is it acceptable to run hemolyzed specimens for coagulation testing? We have a Stago analyzer for coagulation testing and some of my co-workers run hemolyzed specimens on it. Read answer. Q. I am a medical laboratory scientist who would like to move into a laboratory information technology/information systems career to support the growing need of professionals in that aspect of health care. What education is advised and what licensing is required, and do you have any suggestions on how to make such a move? Read answer.

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Newsbytes

March 2023—Interpreting digital pathology images requires a trained eye, but a pathologist and radiologist at Moffitt Cancer Center are working on a tool to make these and other medical images easier for patients to access and understand.  

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From the President’s Desk

  March 2023—Whether you watched Quincy, M.E., like I did as a kid, or something more recent like CSI, many of us encountered pathology for the first time through a TV show. Watching Jack Klugman’s weekly adventures as the L.A. county medical examiner, Dr. Quincy, certainly had me intrigued about the specialty of pathology. While most of us work in clinical or anatomic pathology instead of subspecializing in forensic pathology, it’s the forensics field—and how it’s portrayed in TV and movies—that gives most of the general public the only insight into pathology they get in their daily lives. When people outside the medical field hear about a pathologist, they typically picture someone performing an autopsy and trying to figure out the mystery behind a person’s demise.

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Clinical pathology selected abstracts

February 2023—Fetal and neonatal alloimmune thrombocytopenia is the most common cause of intracranial hemorrhage in term infants with thrombocytopenia. It often presents as severe thrombocytopenia in the newborn or a spontaneous intracranial hemorrhage in a fetus in an uncomplicated pregnancy. Fetal and neonatal alloimmune thrombocytopenia (FNAIT) is caused by maternal antibodies against paternal platelet antigens, which cross the placenta and destroy fetal platelets. Studies have shown that FNAIT is underdiagnosed in pregnancies. However, primigravida screening for FNAIT is not performed in the United States.

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Anatomic pathology selected abstracts

February 2023—Atypical mitosis is considered a feature of malignancy, but its significance in breast cancer remains elusive. The authors conducted a study to assess the clinical value of atypical mitoses in breast cancer and explore their underlying molecular features. They quantified and correlated atypical and typical mitotic figures with clinicopathological variables in a large cohort of primary breast cancer tissue sections (n=846) using digitalized H&E whole slide images. They also used RNA sequencing data from The Cancer Genome Atlas (TCGA) breast cancer data set (n=1,032) to link atypical mitoses to the underlying genetic alterations and pathways.

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Molecular pathology selected abstracts

February 2023—Systemic lupus erythematosus is an autoimmune disease that affects multiple organ systems and is most prevalent in women of Asian, Hispanic, and African ancestries. People with the heterogeneous disease experience major organ damage, which primarily affects the kidneys, skin, heart, and joints. Transcriptomic studies of systemic lupus erythematosus (SLE) have implicated increased type 1 interferon signaling, dysregulated lymphocyte activation, and failure of apoptotic clearance as hallmarks of the disease. Many genes are near the approximately 100 loci associated with SLE. Despite the use of flow cytometry and transcriptome profiling to characterize the role of circulating immune cells in SLE, there is not a complete census of circulating immune cells in the disease, and characterizing the genetic associations has been challenging.

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From the President’s Desk

January 2023—When I was newly elected into my officer role at the CAP in 2019, I had the opportunity to join a meeting of a committee under the umbrella of the Council on Accreditation. This was a committee whose work I knew little about but which I quickly grew to appreciate. In this committee I saw an extreme focus on operational processes and quality management structures. They wanted to prevent errors, not just fix them. This focus on process was different from the focus on blame that we often see in medicine. As I listened to Gaurav Sharma, MD, lead the CAP 15189 Committee, I knew I was among folks dedicated to pushing for ever-better care and quality for our patients and our laboratories.

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Anatomic pathology selected abstracts

January 2023—Radioembolization therapy uses yttrium-90-impregnated resin or glass microspheres to selectively target hepatic lesions via transarterial radioembolization. Occasional cases of gastrointestinal (GI) tract injury secondary to nontargeted delivery of microspheres have been reported, but large descriptive pathology series are lacking.

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Molecular pathology selected abstracts

January 2023—An international group of scientists and clinicians identified the molecular cause of a rare neurodevelopmental syndrome affecting children worldwide. This discovery was made possible through such publicly available online databases as MyGene2, GeneMatcher, and Matchmaker Exchange, which match genotypic profiles with phenotypic profiles of rare diseases.

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Newsbytes

January 2023—The acclaimed film composer John Powell said, “Communication works for those who work at it.” A sentiment to which Yonah Ziemba, MD, adhered when communicating data via charts, graphs, and tables during his pathology fellowship—benefiting himself and others.

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Q&A column

January 2023 Q. I am updating our procedure for blood draw volume limits and using So You’re Going to Collect a Blood Specimen: An Introduction to Phlebotomy, 15th edition, by Frederick L. Kiechle, MD, PhD, as a guide. The chart in the manual lists volume limits for a single blood draw at 2 cc/kg. Other charts online list 2.5 cc/kg and a maximum milliliters per 30-day period that is twice the single blood draw (5 cc/kg). I am going to use 2 cc/kg and add a column for maximum milliliters in a 30-day period at 4 cc/kg. The phlebotomists are confused about whether a single blood draw means every day of the patient’s admission or if you would take the single blood draw and only allow the remainder of the 30-day limit. You could essentially draw the single blood draw volume limit on day one and the remainder on day two. Please clarify. Read answer. Q. An oncologist contacted the laboratory to ask if our standard estradiol immunoassay was appropriate to monitor her breast cancer patients who are on an aromatase inhibitor. What should I say? Read answer.

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Put It on the Board

January 2023—The Association for Molecular Pathology last month released a report on somatic variant classification using 2017 standards and guidelines for interpreting and reporting such variants, which were a consensus recommendation of the AMP, CAP, and American Society of Clinical Oncology.

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Letters

January 2023—The CAP president’s column, “The visible pathologist” (CAP TODAY, November 2022), struck a chord that has been reverberating through our specialty for many years when a medical student who expressed an interest in pathology was asked, “Why don’t you want to be a real doctor?” You put it in terms of “disappearing” as judged by our role in the case of patients.

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From the President’s Desk

December 2022—Many of us were raised on alluring stories of the good old days in medicine, when physicians enjoyed long-term, respectful relationships with their patients. I grew up hearing from my father, an obstetrician/gynecologist, and my mother, a nurse, about their frustrating transition from this to a modern reality in which these relationships were strained by a seemingly impenetrable health care bureaucracy. Like so many pathologists, I have felt intimidated by such behemoths as the CMS, the FDA, and insurance companies, as well as smaller monoliths like the C-suites or dean’s office at health systems and medical schools where I have practiced. But what I have realized by working with the CAP is that dealing with these entities can be more manageable when we create positive and productive relationships with the people who work in them.

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Q&A column

December 2022 Q. What is the appropriate way to measure or identify microcytosis or macrocytosis? Read answer. Q. A six-year-old female with B-cell acute lymphoblastic leukemia and Rh-negative blood is being treated with myeloablative chemotherapy to achieve durable remission or as a bridge to stem cell transplantation, during which supportive transfusions will include repeated platelet transfusions over many weeks. Clinicians are concerned that the patient could become alloimmunized to the D antigen, which, in turn, could affect her ability to eventually bear children. Apheresis platelets contain a small but finite amount of RBC contaminants, which are not usually quantitated. An optimal strategy to prevent anti-D alloimmunization is to use Rh-negative platelets, but they are often in short supply and cannot be ordered stat in a timely enough manner to ensure every platelet transfusion episode is Rh-negative. We considered using Rh immune globulin (RhIg). However, we recognize that commercial RhIg is designed to prevent D alloimmunization in the setting of obstetric fetal-maternal bleeding. Is there an optimal dose for RhIg or suggested timing of administration to prevent anti-D alloimmunization in this setting? Read answer.

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Newsbytes

December 2022—To safely and effectively extend the process of conducting point-of-care testing to staff from various hospital departments is no easy feat. That’s why four full-time employees at Children’s Hospital Los Angeles oversee POC testing, relying heavily on middleware, analytics, and exception-management tools.

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Put It on the Board

December 2022—The Food and Drug Administration has approved the Ventana FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry companion diagnostic test to aid in identifying epithelial ovarian cancer patients who are eligible for targeted treatment with Elahere (mirvetuximab soravtansine-gynx). Elahere is a first-in-class antibody-drug conjugate therapy developed by Immuno­Gen and approved under the FDA’s accelerated approval program for the treatment of FRα-positive platinum-resistant ovarian cancer.

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From the President’s Desk

November 2022—Like me, many of you can remember when you first thought about specializing in pathology, a decision that for a lot of us was made difficult by the notion of “disappearing” from the scene—working behind the scenes and in relative obscurity. As a specialty we are not as self-explanatory as surgery or pediatrics; indeed it can be exhausting for all concerned to explain, even to our fellow physicians, what we do. And so we often find ourselves somewhere between disregarded and misunderstood. Despite this, there is no other specialty with comparable impact. We are aware each time we sign a pathology report that a cascade of usually predictable consequences will ensue, and that upon this work the types of treatment, expectations for response, and tenor of conversations will depend. We know each time we validate a new test, review quality metrics, or accept a specimen for testing that subsequent laboratory results will be accepted as credible and acted upon. In short, while pathologists are not always visible, there can be no doubt that pathologists are palpable.

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Clinical pathology selected abstracts

November 2022—Exposure to lead may cause severe illness in children, including neurological damage, organ failure, and even death. The Centers for Disease Control and Prevention and other agencies recommend routine testing for blood lead levels (BLL) as part of a well-child examination to identify elevated levels and, subsequently, eliminate exposure to lead and initiate therapeutic interventions.

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Molecular pathology selected abstracts

November 2022—Spontaneous coronary artery dissection is an uncommon cause of acute heart attack. It is not associated with high cholesterol or atherosclerosis but, instead, occurs when a small tear or separation in the wall of the coronary artery leads to blood entering a false lumen, occluding blood flow and impairing oxygenation of the heart muscle.

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Pathology informatics selected abstracts

November 2022—Lab test result formats are not standardized, potentially causing confusion when the same test results are displayed differently—for example, when a positive pregnancy test appears as +, P, or positive, or an indeterminate test result appears as DNR, which could be interpreted to mean did not report, did not react, or even do not resuscitate. Because of this issue, the authors trialed standard laboratory result formats across the 130 facilities that are part of the Veterans Health Administration, each of which has one or more CLIA-certified laboratories. The authors selected the most common laboratory tests from each facility, which composed at least 95 percent of a facility’s monthly laboratory test volume between 2000 and 2015. They then specified the standard result formats for these tests based on the facilities’ feedback. Personalized emails were sent weekly, over a 15-week period in 2016, to the facilities’ lab information systems managers, lab managers, and laboratory directors.

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Q&A column

November 2022 Q. Is secretory change in endometrial hyperplasia acceptable in the absence of progestin therapy? What is the appropriate way to address an endometrial biopsy with secretory glandular changes and an increase in the gland-to-stroma ratio? Read answer. Q. I want to inquire about verification of target mean/ranges for hematology analytes. We run a control material 20 times and calculate statistics such as mean, standard deviation, and coefficient of variation. We also calculate total analytical error based on a formula (TAE = bias + 2 SD) and compare the TAE with the allowable total error recommended by CLSI and other sources. For example, if TAE for platelets (based on reading control material 20 times) is less than 25 percent (a CLSI recommended value), we accept the target range; otherwise, we reject it. However, since low concentrations of analytes are prone to a higher degree of variation, the aforementioned target range verification process frequently fails. Is it necessary to accept or reject established target values based on total analytical error? Or is there an alternative way to do that? Read answer. Q. Should an accelerated APTT result be canceled for being clotted, even in the absence of a visible clot? Read answer.

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From the President’s Desk

October 2022—When I was in pathology training back in the ’90s, physicians carried around an index card for each patient, with all of the information we needed to know about them easily covered in that small space. Today, the practice of medicine—and specifically the practice of pathology—looks very different in the era of big data. Of course, we still have to fill our traditional roles: making the correct diagnosis for individual patients and ensuring the integrity of laboratory results. But increasingly large data sets inform the diagnosis in individual cases and, at the same time, individual cases become data points in large data sets that inform the health of populations. Beginning in the 2000s with the value-based care movement and accelerating with the rise of high-parameter tests, we find ourselves having to be data scientists as much as physicians. We are being asked to incorporate data-heavy tests and pipelines, some of which require clinical decision support algorithms that demand a certain fluency with more sophisticated software. We find ourselves in the new position of considering population health in addition to patient health, an element that can involve predictive analytics and data mining.

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Clinical pathology selected abstracts

October 2022—Cardiovascular health is often linked to dementia, and compelling evidence indicates that there are modifiable risk factors for dementia, knowledge of which may also benefit vascular health. In previous studies, hypercholesterolemia and cardiovascular pathology were associated with the apolipoprotein E (APOE) ε4 genotype and cognitive function.

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Q&A column

October 2022 Q. How many blocks should a histotechnologist with multiple responsibilities cut per day in a semiautomated laboratory? Read answer. Q. Is it acceptable to release results from an analyzer with flags or alarms if a pathologist sends an email instructing to do so, even if the manufacturer’s instructions state that results with flags or alarms should be verified by another method before reporting? I am referring to hematology analyzer auto-differential results with asterisk flags. The emailed instructions from the pathologist are applied to all samples but are not incorporated into our standard operating procedure. We report auto-differential results that have asterisk flags and then perform a manual differential. The report, therefore, contains two differential results that, when compared, are almost always different clinically and statistically. Read answer. Q. How useful is an aPTT value if the value falls below the reference interval? Read answer.

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Newsbytes

October 2022—Cater to your audience, while sage advice, can be a challenging proposition when it comes to choosing a biobank information system. Unlike clinical laboratories, which use lab information systems that tightly link specimen testing results to patient information in the EHR, biobanks need specimen-centric systems that can store and track samples for research purposes. Biobanks, like research laboratories, need the functionality typically found in laboratory information management systems, or LIMS, says Raj Dash, MD, pathologist and director of laboratory informatics strategy, Duke Health.

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Letters

October 2022—I read with great interest your article “Transgender care, in and beyond the lab” (July 2022). In the article Gabrielle Winston-McPherson, PhD, talks about her desire to improve health outcomes, identify problems in the preanalytical process, develop training material, assemble data and information prior to implementation, address informatics challenges, and ensure proper allocation of limited resources—all of which is laudable and appears to align perfectly with our mission as pathologists. The writer reminds readers that the topic has landed in the middle of court cases, state laws, and policy debates, with “words like ‘controversial,’ ‘issue,’ ‘politics,’ ‘traditional family values,’ and ‘beliefs’ awkwardly mixed in with medical realities.”

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Put It on the Board

October 2022—The Food and Drug Administration has granted approval to Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic to aid in selecting patients with RET-fusion-positive locally advanced or metastatic non-small cell lung cancer, RET-fusion-positive advanced or metastatic thyroid cancer, and RET-mutation-positive advanced or metastatic medullary thyroid cancer who may be eligible for treatment with Lilly’s Retevmo (selpercatinib).

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From the President’s Desk

September 2022—Like so many pathologists, I have been keeping a close eye on the VALID Act, which would create a new framework for FDA oversight of laboratory-developed tests (LDTs). As I write this, the VALID Act has been voted out of a Senate committee and now awaits further action by the full Senate. I have heard from some pathologists and laboratorians who are concerned about this legislation and about the CAP position on it since the Senate HELP Committee released a draft on May 17, 2022. If you have not followed this bill and the issues of LDT oversight, allow me to offer some context. Regulatory oversight of LDTs has been in active discussion since 2008 when the FDA intervened with a national reference laboratory that was selling a test that had been developed at a prestigious university to identify high-risk women who might have ovarian cancer. Patient advocacy groups had raised a concern because several women had undergone unnecessary prophylactic bilateral oophorectomy based on this LDT. In response, the FDA expressed concern about the public harm, and the reference laboratory pulled the test from the market.

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Clinical pathology selected abstracts

September 2022—Clinical laboratory workforce shortages are an issue, in large part because it is difficult to find qualified testing personnel. Pathology residents present a solution to this problem because MD and DO residents who have current training certificates or medical licenses and who are trainees in pathology or other specialties can qualify to perform high-complexity testing.

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Pathology informatics selected abstracts

September 2022—Artificial intelligence in pathology has progressed recently, with at least four machine-learning algorithms classified for clinical use in the United States. While many challenges of implementing AI in pathology labs are well documented, one area that has not received much study is how an AI algorithm designed to augment pathologist performance will impact pathologists’ clinical decisions.

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Molecular pathology selected abstracts

September 2022—The widespread availability of next-generation sequencing-based somatic mutation analysis of solid tumors has led to the routine identification of patients eligible for FDA-approved targeted therapies, including immunotherapies. However, validated targeted therapies are available for only a small number of mutations, thereby preventing many patients from realizing the benefits of these life-extending modalities. With a focus on reducing the gap in eligibility for targeted therapy, the authors conducted a large-scale retrospective analysis of interactions between mutations, drug responses, and long-term cancer survival outcomes. They performed the analysis using the nationwide U.S.-based Flatiron Health–Foundation Medicine clinicogenomic database. The authors analyzed data on more than 40,000 patients from approximately 280 cancer clinics.

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Q&A column

September 2022 Q. The laboratory at which I work uses two proficiency testing programs—from the CAP and an alternate provider—for dermatologists who perform fungal smears. Our laboratory administers challenges for both programs every six months. The dermatologists have variably passed and failed challenges from both programs such that the record of satisfactory challenges alternates between the CAP and the alternate provider’s programs. Is our approach allowed? Do we need to stick with a single PT provider for one year before switching? Read answer. Q. Should flow cytometry be used to test a cerebrospinal fluid specimen with known or suspected Creutzfeldt-Jakob disease? Our hospital administration is pushing to run such samples. I think the testing should not be done because it would contaminate the instrument and potentially endanger the flow techs. Read answer.

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Newsbytes

September 2022—Do you want to play a role in solving a problem or improving a process in your laboratory via machine learning or artificial intelligence but don’t know where to begin? If so, take some time to learn, listen, share, and, perhaps, have a cup of coffee, says Scott Doyle, PhD, biomedical engineer at the State University of New York at Buffalo.

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Put It on the Board

September 2022—The Food and Drug Administration on Aug. 11 granted accelerated approval to Enhertu for adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. Enhertu (AstraZeneca and Daiichi Sankyo) is the first drug approved for HER2-mutant NSCLC.

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From the President’s Desk

August 2022—The CAP has been advocating for an increase in residency slots that would help give more young physicians the opportunity to embrace careers in pathology. We support the Resident Physician Shortage Reduction Act, bipartisan legislation that is working its way through both chambers of Congress. It would add 14,000 Medicare-supported residency slots over the course of seven years and help ensure an open pipeline for pathologists. Between pandemic burnout and the retirement cliff resulting from an aging population of physicians, we are facing a shortage of all physicians, pathologists included. The CAP projects that the number of pathologists will shrink in the coming years. Unfortunately, when there are not enough pathologists to lead clinical laboratory teams, it creates a gap that has to be filled somehow. Many of us have already seen health care gaps being filled by people with less extensive and intensive training.

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Newsbytes

August 2022—Transfusion medicine specialists at Phoenix Children’s Hospital may be used to trending laboratory biomarkers for sickle cell disease patients in their heads, but a dashboard supporting red blood cell exchange procedures for such patients eases the burden on their cerebral cortices.

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Q&A column

August 2022 Q. Every month our anatomic pathology laboratory amends patient reports. Does the CAP have a benchmark for amended reports, such as how many are acceptable per month? Read answer. Q. What is the best practice for performing a urine specific gravity test? Which method is preferred—a refractometer or an automated dipstick? Should we correct for elevated glucose and protein or report high specific gravity? Should we correct for x-ray dyes or add a comment and list possible interfering substances? Read answer.

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Put It on the Board

August 2022—The FDA has granted breakthrough device designation to Roche’s Elecsys Amyloid Plasma Panel for detection of early Alzheimer’s disease. It detects and measures AD biomarkers in blood plasma to indicate the need for further confirmatory testing.

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From the President’s Desk

July 2022—The CAP has been looking to identify areas where pathologists can help overcome institutional bias in medicine. As you may have seen, the CAP recently issued a statement supporting a new position from the American Medical Association that calls for a change to the FDA’s policy about blood donations from men who have sex with men. The current rule, established in early 2020 in response to a drastic blood shortage associated with pandemic lockdowns, prohibits blood donations from gay or bisexual men who have engaged in sexual activity in the prior three months. Previously, only gay or bisexual men who abstained from sex for a full year were eligible to donate blood. Many of you remember as I do the societal rejection of HIV-positive patients that occurred in the late ’80s. I was in medical school at this time, working at the county hospital in Kansas City, Mo. A lack of access to health care elsewhere was only one form of rejection to which our HIV-positive patients were subjected.

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Clinical pathology selected abstracts

July 2022—A complete blood count with a white blood cell differential (CBCD) is often ordered when a CBC alone would suffice. Even though a CBCD can be performed with automated technology, it requires more reagents than a CBC. Furthermore, if an automated CBCD is flagged, a laboratory will perform a manual WBC differential, adding to labor and material costs.

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Molecular pathology selected abstracts

July 2022—Although offspring share similar DNA, their physical and behavioral differences are multifactorial. One of those factors is epigenetics, the chemical and structural modifications of DNA by proteins and enzymes. Whereas the DNA sequence is relatively stable, epigenetic modifications are dynamic, as they are critical to controlling gene expression in response to cellular development and environment. Reproductive cells, or gametes, carry half the normal set of chromosomal DNA. Advances in molecular technologies demonstrate that this DNA is epigenetically modified to influence traits of future offspring, referred to as transgenerational epigenetic inheritance.

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Q&A column

July 2022 Q. When a patient has a hematocrit level of ≥55 percent and a normal PT and APTT, do you still correct sodium citrate and ask for a redraw? Is it crucial to ask for a redraw when the emergency department orders a stat PT and APTT? Read answer. Q. Obtaining an accurate blood glucose level is hindered by continued glycolysis in the evacuated tube post collection, even if a gray top tube is used. This leads to falsely low blood glucose levels. What can laboratories do to limit ex vivo glycolysis? Read answer.

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Newsbytes

July 2022—If a machine-learning algorithm is trained to help detect cancer in whole slide images at one health care location, shouldn’t the same algorithm work on digital slides from a similar patient population at another site?

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July 2022—Paige has received CE-IVD and UKCA (UK Conformity Assessed) marks for its HER2Complete artificial intelligence software. In a recent study, HER2Complete was able to detect levels of HER2 expression in HER2-negative (IHC 0) and HER2-low (IHC 1+/2+) H&E-stained tissue samples, Paige said in announcing the news.

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From the President’s Desk

June 2022—You’re probably familiar with the expression “jack of all trades, master of none.” While that sounds disparaging, it’s actually taken out of context. The original quote in its entirety is, “A jack of all trades is a master of none, but oftentimes better than a master of one.” It was intended as a compliment for someone who had good, broad knowledge. The widespread misinterpretation of that quote supports a common idea that no individual can be really good at a lot of different things. But pathologists challenge that concept every day. While many of us subspecialize, we are able to fall back on our broad training when circumstances require it. Such may be the case when encountering pathologic findings that indicate a disorder not commonly found in our area of expertise, or findings that indicate a systemic illness. Many of us find that we have to be experts on different things on different days and in different parts of our career.

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Newsbytes

June 2022—Laboratories seeking a means to query their repository of archival anatomic pathology reports would do well to follow the advice of former tennis star Arthur Ashe: “Start where you are, use what you have, do what you can.”

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Q&A column

June 2022 Q. Can bronchoalveolar lavage specimens from multiple lobes be pooled for culture? Can multiple biopsies from the same joint be pooled for culture? Read answer. Q. We verify our reference intervals with each new reagent lot for coagulation tests (PT, APTT, fibrinogen, and TT). What difference in values between lots necessitates establishing a new reference interval? A CAP TODAY Q&A from January 2015 mentions limits within 1.5 seconds of each other between new and old reagent lots for human recombinant PT. What about limits for APTT and fibrinogen? Read answer.

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June 2022—Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) in April was granted breakthrough therapy designation for treating patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed recurrence during or within six months of completing adjuvant chemotherapy.

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From the President’s Desk

May 2022—In the 1990s, as immunohistochemistry was first adopted in clinical laboratories, there was palpable fear among many pathologists who believed our expertise would no longer have a role in health care. The prevailing sentiment at the time was, “If the brown stain lights up, you know it’s cancer, and they won’t need pathologists anymore.” Of course, nothing could have been further from the truth. Having IHC capabilities meant there was more information that we had to process. It enabled us to extract more information from a tissue sample and to do more for our patients, but it also required more of us in terms of test selection, test interpretation, and communicating what it all meant to our fellow clinicians. More recently, next-generation sequencing has given us more, not less, to do; far from replacing us, such innovations require more of us to realize their full potential. These additions have not necessarily made our lives easier, but they have absolutely made what we can offer our patients richer and more precise.

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Molecular pathology selected abstracts

May 2022—The most common cause of death related to gynecological malignancies is epithelial ovarian cancer. One of the biggest challenges to treating this disease is the lack of reliable biomarkers for identifying its underlying precancerous and early stages. The study of epigenetic changes in epithelial cells shows some promise for detecting early ovarian cancer. In previous studies, DNA methylation performed on blood samples demonstrated important epigenetic changes associated with ovarian cancer but did not yield realistic screening parameters due to the heterogeneity of blood samples. To identify ovarian cancer risk earlier, the authors conducted a molecular epigenetic analysis of cervical epithelial cells derived from the Mullerian duct and collected using the ThinPrep system to establish a methylation model index called the Women’s Risk Identification for Ovarian Cancer [WID-OC] index.

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Q&A column

May 2022 Q. Should peritoneal dialysis fluid collected directly from a patient be considered peritoneal fluid or peritoneal dialysate fluid? A clinician at my institution placed an order for peritoneal dialysate fluid because the fluid was to be collected from the patient, not from the bag. Read answer. Q. What types of materials (for example, QC materials, patient samples, or both) can be used to check new reagent lots on my chemistry analyzer? We have three chemistry analyzers of the same model. Do we need to perform reagent lot studies on all three? Read answer.

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Newsbytes

May 2022—If the pandemic proved nothing else, it proved that necessity is the mother of invention. And invention was top of mind when two like-minded employees from different institutions tackled education and training in blood banking and transfusion medicine during the past two years.

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May 2022—The Department of Health and Human Services and the Centers for Medicare and Medicaid Services should engage laboratory stakeholders early and across the spectrum of care delivery environments before laboratory policies are implemented in public health emergencies, the Association for Molecular Pathology says in a report released April 19 titled “Economics of Testing During a Public Health Emergency: Lessons Learned from Two Years of COVID-19.”

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From the President’s Desk

What you’ll get from the Leadership Summit
April 2022—The end of this month marks the start of one of my favorite CAP events: the Pathologists Leadership Summit. If you’re not familiar with it or haven’t signed up to attend, I’d like to give you a sense of why it’s so important. Back in the early 2000s, I attended what was known as CAP Advocacy School. At that point in my career, I had seen many physicians who felt discouraged, frustrated, and helpless about the state of physician payments and government health care regulations, and I understood those feelings. Advocacy School offered a solution. What struck me about this program was the message that we were not powerless. Through this meeting, the CAP taught me that my government representatives would be interested in what I had to say as an expert physician. I was partnered with Richard Hausner, MD, a seasoned pathologist advocate.

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Q&A column

April 2022
Q. Is it necessary to perform a manual cell count for body fluids, including CSF, using a hemocytometer? Can clinical decisions be made based on low cell counts in body fluid reported by automated cell counters since these instruments have decreased precision and accuracy with low counts? Read answer. Q. Is there a time limit for a critical value—for example, when a specimen is drawn at 8 AM, the lab receives it at 5 PM (due to courier issues) and has a result at 10 PM, and the value falls in the critical range? Since it is now 14 hours after the draw, the lab value may no longer be actionable. No clinician would act on a critical value that is a week old, so at what point is the lab value no longer considered critical? Read answer. Q. Given that blood specimen collection tubes are in short supply, many laboratories may need to switch to an alternative collection tube manufacturer. What validation studies are necessary before an alternative collection tube can be implemented? Read answer.

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Newsbytes

April 2022—Michelle Stoffel, MD, PhD, supports the use of Excel spreadsheets in some areas of laboratory medicine, but not necessarily as a laboratory workflow tool. It’s a realization she came to when, as a clinical informatics fellow at the University of Washington School of Medicine, she led the charge to revamp the workflow for the immunology laboratory’s Merkel cell antibody panel.

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April 2022—Cofactor Genomics announced publication of a study showing that its multianalyte biomarkers based on T cell subtype profiling (TCSP) predicted patient response to anti-PD-1 therapy in three cancers (lung, melanoma, head and neck) and outperformed the indicated PD-L1 test and tumor mutational burden (Schillebeeckx I, et al. Sci Rep. 2022;12[1]:1342).

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From the President’s Desk

Strengthen your state societies
March 2022—If you’re reading this column, you’re likely a member of the CAP. But are you also a member of your state pathology society? Too many pathologists think that joining the CAP is enough. The truth is, the CAP can have a greater impact—and pathologists can be more effective physician advocates for their patients—when partnering with robust state pathology societies. State societies are essential because so many of the policies and regulations governing our work as pathologists are enacted at the state level. Balance billing rules, scope of practice issues, and insurance regulations are often decided by each state. So many issues about how we are licensed, how we practice, and how we get paid are regulated at the state level.

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Anatomic pathology selected abstracts

March 2022—Invasive gallbladder carcinoma is preceded by two main types of precursor lesions—intracholecystic papillary-tubular neoplasms and biliary intraepithelial neoplasias. Invasive gallbladder carcinomas with an intracholecystic papillary-tubular neoplasm (ICPN) component have more favorable prognoses than those without an ICPN component.

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Pathology informatics selected abstracts

March 2022—Over the past decade, the field of pathology has increasingly been using Twitter for educational purposes, due in part to the ease with which one can share images for review on the social media platform. However, not all pathologists use Twitter, and only a portion of those who do use it employ the platform for educational purposes. To identify the challenges of using Twitter to create educational posts, the authors created a short multiple-choice Likert scale survey using Google Forms and distributed it through Twitter. The survey was divided into the categories of user demographics—work setting, job role, and history of posting educational content on Twitter; the biggest obstacle to creating educational content; and further exploration of the challenges faced when posting content to Twitter. One hundred and seventy-four medical professionals responded to the survey, of which pathology residents and fellows (n = 68; 39.1 percent) and practicing pathologists (n = 60; 34.5 percent) composed the largest groups.

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Newsbytes

March 2022—Medical professionals and, more importantly, patients at Virginia Commonwealth University Medical Center are benefitting from a synoptic reporting system that allows the pathology lab to assess the quality of all bone marrow specimens that it receives.

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March 2022—The CAP was one of eight pathology and laboratory organizations to endorse in a joint statement the use of the CKD-EPI 2021 race-free equations for calculating estimated glomerular filtration rate. The others are the Academy of Clinical Laboratory Physicians and Scientists, American Association of Clinical Chemistry, American Society for Clinical Pathology, Association of Pathology Chairs, Clinical Laboratory Management Association, National Independent Laboratory Association, and Society of American Federated Medical Laboratory Scientists (the views of the SAFMLS do not represent the views of the U.S. government). Following is the statement they released on Jan. 31.

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From the President’s Desk

The time for courage
February 2022—We pathologists tend to share traits common among physicians: We are often type A overachievers, driven by perfectionism, our own unrealistic expectations, and a deep fear of failure. Normally, these characteristics help us to achieve our goals, in life and in caring for patients. But these are not normal times. In the COVID-19 pandemic, it is almost impossible to feel like we’re doing a good job. Like so many of you, I am working significantly long­er hours than usual. At the end of each day I am often left with a sense of despondency that there’s not enough time to get everything done, or to do it all as well as I would like.To get through this crisis, we have to let go of our perfectionism and embrace doing what we can. We need to accept that if we’re doing what we can, it’s enough. Even if our individual efforts seem inadequate in dealing with this pandemic nightmare, the collective effort is adequate. Each day in my hospital I feel like I’m taking a bath in COVID-19. But I go home, rest up, and do it again the next day.

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Anatomic pathology selected abstracts

• Use of subtyping to predict behavior of papillary thyroid microcarcinomas • Gastrointestinal pathology in samples from COVID-19–positive patients • Assessment of an artificial intelligence system for prostate cancer detection • Expression patterns for Bcl-2, EMA, β-catenin, E-cadherin, PAX8, and MIB-1 in thymomas • Analysis of intraoperative frozen section biopsy of uterine smooth muscle tumors

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Newsbytes

February 2022—Ask TRUU-Lab founder Ila Singh, MD, PhD, what’s in a name and she will provide an answer that differs greatly from that of Shakespeare’s Juliet Capulet. According to Dr. Singh, the answer can be too much information, not enough information, or ambiguous terminology—when referring to lab test names, that is.

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February 2022—Siemens Healthineers’ Enhanced Liver Fibrosis test is available in the United States, exclusively through collaboration with Labcorp and Quest Diagnostics. This commercial availability in the U.S. follows de novo marketing authorization from the FDA in August 2021.

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From the President’s Desk: The CAP for the next generation

The CAP for the next generation January 2022—Happy New Year! Most of us start each year with resolutions, fresh budgets, or perhaps yearlong plans. This is often the time we think about the future and the choices we need to make now to achieve those long-term goals. In that spirit, I’ve been thinking about how important it is for the CAP to continually engage with and mentor the newest members of our pathology community. Residents and early-career pathologists bring vibrant energy to our ranks, and many of them will eventually contribute to the leadership of the CAP. While we always value the experience and wisdom of our more seasoned fellows, it is essential that we also make space to train up-and-coming leaders.

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Q&A column

January 2022 Q. When reporting reference ranges for absolute differential counts, should the ranges be age specific or is a single reference range acceptable? Read answer. Q. Is it acceptable to use polystyrene tubes for aliquotting plasma for coagulation tests, such as platelet aggregation, and factor-related studies requiring serial dilutions of plasma? I recall seeing recommendations for using nonpolystyrene tubes for frozen plasma aliquots but did not see a reason for the recommendation. Read answer.

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Newsbytes

One pathologist’s foray into 3D printing
January 2022—The use of three-dimensional printing in the pathology lab may still be in its infancy, but pathologist Danielle Lameirinhas Vieira Maracaja, MD, and her anesthesiologist husband have been affirming its value to pathologists, and the medical community in general, for years. Dr. Danielle Maracaja, a pathologist at Atrium Health Wake Forest Baptist, Winston-Salem, NC, and assistant professor of pathology at Wake Forest School of Medicine, has been working alongside her husband, Luiz Maracaja, MD, associate professor of anesthesiology at the same hospital and medical school, in designing and producing medical tools using 3D-printing technology for more than five years. They took on one of their largest projects in early 2020, when Dr. Danielle Maracaja was a pathology fellow at Yale University School of Medicine and COVID-19 cases were spiking.

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January 2022—The Food and Drug Administration granted 510(k) clearance for SeptiCyte Rapid, which runs on Biocartis’ molecular diagnostics Idylla platform. It’s a fully automated, rapid host-response test that distinguishes sepsis from infection-negative systemic inflammation in patients suspected of sepsis.

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From the President’s Desk: Leaders by nature

December 2021—When I became a pathologist more than 20 years ago, I never imagined I would have the opportunity to serve as chief medical officer at a hospital. But I can see from my new position how a background in pathology has prepared me for hospital leadership. In fact, the very traits that led us to become pathologists are the ones that make so many of us natural leaders. We are nimble thinkers who can simultaneously appreciate the big picture and the tiny details. Likewise, we can think concurrently about population health and individual patients. Our ability to see and understand these perspectives so clearly is a huge advantage. Because our specialty touches many different aspects of medicine, we are comfortable interacting with all segments of the health care system—from operative services and radiology to the emergency department, medical wards, and ambulatory setting.

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Newsbytes

December 2021—Like death and taxes, cyberattacks targeting health care organizations are a certainty, but taking proactive breach mitigation measures and developing a thorough response plan can lessen, or even prevent, a devastating blow.

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Q&A column

December 2021 Q. We use the CAP Competency Assessment Program to create quizzes to satisfy the problem-solving element of the CAP’s competency assessment requirements. Is there a requirement to create a new quiz each year or can the same quiz be given every year? Is it OK to use the same quiz for the initial competency and the annual competency? Read answer. Q. Are there red blood cell parameters, such as RBC count or mean corpuscular volume, that can affect a platelet estimate? When determining a platelet estimate, should we always look at the same area of the slide regardless of the patient’s RBC, hematocrit and hemoglobin levels, and indices results? Read answer.

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December 2021—In the COVID-19 pandemic and future pandemics, the existing expertise of clinical laboratories should be taken advantage of and labs should be enabled to validate and offer robust clinical assays, say the authors of “The Role of Clinical Laboratories in Emerging Pathogens—Insights from the COVID-19 Pandemic,” published Oct. 29 in JAMA Health Forum (2021;2[10]:​e213154).

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From the President’s Desk: Keeping the truth

November 2021—In the past two years we have seen the lethal effect of a lack of trust in science. As physicians, pathologists, and fellows of the College of American Pathologists, our duty now as always is to prevent harm, the threat of which comes from mistrust and misinformation. It has always been our role to be revealers of truth, keepers of truth, and producers of clear, reliable information. Our profession and the entire CAP are based on the idea that there is a single truth that can be found through a laboratory value—a truth about a patient’s pathophysiology at a moment in time. This belief that there exist objective truths in medicine is fundamental. In fact, if the laboratory were not a reliable source of truthful information, then pathologists would have a much diminished role, if any at all, to play in clinical medicine. With the truth, pathologists are incredibly important. Without it, much less so. The founders of the CAP understood that.

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Pathology informatics selected abstracts

November 2021—When the COVID-19 pandemic struck, many pathology training programs scrambled to formulate a plan to teach their pathology residents in a physically distanced learning environment. Using double- or multi-headed optical light microscopes, even with plexiglass barriers, is not ideal because they do not permit physical distancing. Many training programs leveraged digital imaging technology to continue teaching microscopy during the pandemic. Pathology departments that could not afford whole slide imaging for this purpose sometimes employed the less expensive option of dynamic virtual microscopy (DVM). A DVM platform includes a digital camera mounted to a light microscope and videoconferencing software so an educator can stream a slide image to one or more remote learners.

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Newsbytes

November 2021—The following is an edited excerpt of the article “Attention-based deep multiple instance learning,” written by Jonathan Glaser, a recent graduate of the computer science and biotechnology master of science degree programs at New York University Tandon School of Engineering, in Brooklyn. The excerpt delves into how aspects of artificial intelligence can transform health care, and pathology in particular. To read the full article, go to https://tinyurl.com/AI-based-learning.

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Q&A column

November 2021 Q. I am a nurse in a cardiac cath lab that performs point-of-care testing, including for activated clotting time. At my hospital, the POC testing coordinator only allows other cath lab staff, usually nurses, to use POC testing equipment if they have a copy of their diploma. Can staff who have proof of licensure (such as from the American Registry of Radiologic Technologists) but do not have a copy of their diploma be authorized to use POC testing equipment? Read answer. Q. I recently joined a hospital laboratory that verifies reagents lot to lot with patient samples using a percentage difference of 10 for all parameters. The hospital lab where I previously worked used a CLIA allowable-error percentage. Is 10 percent allowable error acceptable for reagent lot-to-lot verification for all parameters? Read answer.

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From the President’s Desk: Welcome home

October 2021—I was born into the home of medicine. With a father who was an obstetrician/gynecologist and a mother who was a nurse, there was virtually no separation between our home and medical practice. And while I value how much medicine has shaped my life, I should probably note that my health-care–focused upbringing was little consolation to the parents of my third-grade classmates when I brought in a human placenta for show and tell and delivered some unwanted birds-and-bees education in the process. While medicine has always felt like home to me, as a pathologist, the CAP has become my home as well. This organization has given me a sense of belonging and tremendous opportunity. The first CAP committee I served on was the Cytopathology Resource Committee. I had the privilege of attending the historic Bethesda meeting where we determined how Pap tests would be reported going forward. That system is still in place today.

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Anatomic pathology selected abstracts

October 2021—Squamous cell carcinoma is the most common malignancy of the anal canal and is strongly associated with human papillomavirus (HPV) infection. Characteristic genomic alterations have been identified in anal squamous cell carcinoma (SqCC), but their clinical significance and correlation with HPV status, pathologic features, and immunohistochemical markers are not well established.

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Q&A column

October 2021
Q. After naloxone is administered, are opiates still detectable in the body? If so, for how long and in what quantities? Read answer. Q. Why do proficiency testing specimen results for common immunoassay analytes sometimes vary greatly with different instrument manufacturers and their reagents? Does that mean the patient’s results for the same specimen could vary greatly based on the instrument used? If so, is this acceptable? Wouldn’t the variation in results confuse the clinician and patient? Read answer.

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Newsbytes

October 2021—Given Penn Medicine’s reputation for high operational standards, it’s not surprising that the developers of its new Center for Applied Health Informatics set lofty goals for the center: coordinate the efforts of multiple internal technology-related groups to further improve systems institutionwide and position the health system as a global leader in health informatics.

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October 2021—The Food and Drug Administration granted 510(k) clearance for use of the MeMed BV test on the point-of-need platform MeMed Key to help providers distinguish between bacterial and viral infections. The technology has been cleared for children and adults.

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From the President’s Desk: Looking back, looking ahead

September 2021—As my term as president of the College of American Pathologists comes to a close, I am both honored and humbled to have been selected by my peers for this position. Over the past two years our organization was presented with the greatest challenge we have ever faced. Because of our phenomenal members and staff, we have accomplished great things even though we worked under the most adverse conditions. We, yet again, backed a horse named CAP. It broke out of the gate well and had to weave through traffic on a bad track, but we are ahead. We made the right bet and I am so, so lucky to have been chosen to be the jockey for this race. Looking back, the COVID-19 pandemic presented our community with relatively sudden and profound changes resulting in a tremendous number of challenges. It has dominated our lives. We should be proud of our accomplishments. We have not only put out many fires and sewn up deep wounds, but we have also set up the College and our fellows for continued success so that we will be able to keep serving our patients well.

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Clinical pathology selected abstracts

September 2021—Colorectal cancer is the third leading cause of cancer death for men and women, with approximately 52,980 deaths projected this year. Although colorectal cancer is most frequently diagnosed in adults between the ages of 65 and 74 years, about 10.5 percent of new colorectal cancer cases will occur in those younger than 50 years of age.

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Newsbytes

September 2021—When Stephen Hewitt, MD, PhD, went down the COVID-19 rabbit hole in early 2020, little did he know about the long-term value of a comprehensive COVID-19 digital pathology repository—and how such a project would come to fill his days and, occasionally, nights.

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From the President’s Desk: A step forward

August 2021—No doubt about it, in-person meetings are coming back. I went from a record-long stretch at home because of the pandemic to attending events all over the country. I hasten to add that my entire family is fully vaccinated, and we were so at our first opportunity. As I write this in July, I just returned from an in-person professional development meeting, and I am reminded that virtual meetings are nowhere near as effective as face-to-face meetings. That’s why I am pleased that CAP21 will be a hybrid meeting this year. It’s a step back to normal and will allow people to engage in the way that’s most comfortable for them as the COVID-19 pandemic continues in our country. It feels good to have the opportunity to come back together. I think one of the many reasons our country is so divided now is that we have been separated from each other for so long. At a recent CAP meeting I attended, there was a disagreement during one particular session. After it ended, everyone involved got together face to face, talked through the issue, and came to a good resolution.

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Anatomic pathology selected abstracts

August 2021—Pseudocarcinomatous squamous hyperplasia within the bone is uncommon and closely mimics well-differentiated squamous cell carcinoma. It arises from cutaneous or mucosal surfaces and grows directly into the bone. The authors conducted a study in which they analyzed a series of 31 pseudocarcinomatous squamous hyperplasia (PSH) cases and discussed the clinicopathologic features that distinguished PSH from squamous cell carcinoma (SCC).

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Clinical pathology selected abstracts

August 2021—The primary target organ of the SARS-CoV-2 virus is the lung. The virus invades endothelial cells through angiotensin-converting enzyme 2 receptors, which are found throughout the body. There are multiple markers of abnormal coagulation and hemostasis activation in patients with COVID-19 that signal a risk of thromboembolic complications.

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Q&A column

August 2021
Q. Is it necessary for a lab to report a corrected sodium level when the glucose level is really high? Studies show pseudohyponatremia can occur due to hyperglycemia. How common is this, and how do we decide which correction factor to use? Is it possible that this is easily overlooked by providers due to comorbidities in patients? Some references say there is a need to correct glucose for each 100 mg/dL increase above 400 mg/dL glucose. Read answer.
Q. Payers are limiting reimbursement for PCR respiratory panels to a small subset of tested pathogens and only with certain indications. Many panels available from manufacturers test for more pathogens than can be reimbursed. What is the best approach to deal with this issue? Should large respiratory panels no longer be offered? If a large panel is performed, should only a limited number of pathogen results be reported, even though the entire panel was performed? Should the entire panel be reported but only a limited number of pathogens billed for? Read answer.

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Newsbytes

August 2021—The Office of the National Coordinator for Health Information Technology released last month the United States Core Data for Interoperability version two, or USCDI v2, a standardized set of health data classes and constituent data elements for nationwide, interoperable health information exchange.

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From the President’s Desk: ‘Divided we fall’

July 2021—It has been a long time since the American public has been so terribly divided by politics. So many topics seem polarizing in our country right now. As pathologists, we should not allow these forces to fragment us. I fear that if we are not careful, we could find our community pulled apart, and that would be detrimental to those we should most protect—our patients. I’ve been thinking a lot lately about the phrase, “United we stand, divided we fall.” It is well worn but still meaningful. It’s the official motto of the Commonwealth of Kentucky, where I was born. Within the CAP and each state’s pathology society—in my view, the two groups every pathologist should belong to—it is imperative that we stick to the topics that unite us to keep our organizations strong and inclusive. We are all pathologists or soon-to-be pathologists, and we are all physicians. We are united on measures that allow us to better serve our patients and protect our practices. We should not be divided by politics, and there is no room for that in the CAP or state-level pathology societies. I am not saying that we should not individually be politically active or work peacefully in other politically active groups.

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Clinical pathology selected abstracts

July 2021—Pathologists play a key role in molecular and genomics testing, so pathologists-in-training should demonstrate an understanding of genetics concepts and the utility of molecular and genomic testing in patient care. A list of published competencies for training includes determining sample adequacy, ensuring that appropriate molecular tests are ordered, and effectively communicating genomic testing results through pathology reports and interdisciplinary teams.

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Pathology informatics selected abstracts

July 2021—Despite growing awareness of whole slide imaging, few pathology laboratories have implemented and validated such a digital pathology system for primary diagnosis. Among the barriers to adopting whole slide imaging (WSI) for routine clinical work is the difficulty of justifying the expense, time and effort, and change management involved in deploying this disruptive technology.

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Molecular pathology selected abstracts

July 2021—The accurate diagnosis of malignant pleural mesothelioma is important because of its association with asbestos inhalation and because it is an aggressive tumor with poor outcome despite multimodal treatment. Unfortunately, however, diagnosing malignant pleural mesothelioma is not straightforward. Initial diagnosis often occurs on small biopsies, and the disease has morphologic overlap not only with other neoplasms that affect the lungs and pleura, such as solitary fibrous tumor or synovial sarcoma, but also with reactive conditions, such as reactive mesothelial hyperplasia or sclerosing fibrous pleuritis. While immunohistochemical markers can provide ancillary information, many of them are nonspecific and can lead to diagnostic dilemmas. Sequencing of cancer genes can help in some situations but cannot provide a definitive diagnosis.

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Q&A column

July 2021
Q. Our lab does not have reference ranges established for body fluid manual differentials. Is it acceptable to use ranges from a reference material and include a disclaimer citing the source of the ranges? Read answer.
Q. In our lab, we perform semen analysis and make slides to send out for sperm morphology using Kruger’s strict criteria. We get quite a few results back as swollen sperm head for probable contamination. The reference lab insisted that liquefying agent was added, but when we reviewed the results, the sample was normal, so liquefying agent wasn’t used. What can cause a sperm head to swell, other than liquefying agent? Read answer.

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Newsbytes

July 2021—As the role of informatics in the practice of medicine continues to grow, so does the need to move formalized informatics education from the category of luxury to necessity, says Bruce Levy, MD, associate chief medical informatics officer at Geisinger Health System, Danville, Pa., and professor and program director of the clinical informatics fellowship at Geisinger Commonwealth School of Medicine.

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From the President’s Desk: Unionization?

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.

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Clinical pathology selected abstracts

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.

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Molecular pathology selected abstracts

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.

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Q&A column

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.

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Newsbytes

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.

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Put It on the Board

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.

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From the President’s Desk: What to expect from the American Rescue Plan

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.

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Molecular pathology selected abstracts

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.

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Q&A column

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.

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From the President’s Desk: ‘The end of the beginning’

April 2021—“Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.” I thought of this Winston Churchill quote when I, along with many others, received my first COVID-19 vaccine in December. Unfortunately, this country would go on to experience a second peak. My counterparts in other countries remind me of their third peak. Still, we are well along in the end of the beginning. By the time this column reaches you in mid-April, COVID-19 metrics will have changed, and I believe will be better. This is being written in early March and positive indicators are abundant. Testing availability has increased substantially. In the U.S., reported new daily infections have fallen significantly from their peak in January, while more than 10 percent of the public is now fully vaccinated against the virus.

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Clinical pathology selected abstracts

April 2021—The incidence of cardiovascular disease and coronary heart disease is disproportionately higher among African-Americans compared with non-Hispanic whites. It has been hypothesized that genetic variation is associated with these higher rates of cardiovascular disease (CVD) and coronary heart disease (CHD) among this race.

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Q&A column

Q. What is the recommended procedure for analyzing cerebrospinal fluid from patients suspected of having Creutzfeldt-Jakob disease? In addition to sending the specimen to the National Prion Disease Pathology Surveillance Center for 14-3-3 testing, should the laboratory perform a cell count and/or meningitis panel? Read answer. Q. Is light protection needed for folate samples? Most major reference laboratories do not require folate samples to be protected from light, and I could not find any studies on the topic. Read answer. Q. Many times a platelet count on an automated hematology system indicates some degree of thrombocytopenia or the analyzer reports a high mean platelet volume or platelet large cell ratio, while a blood smear shows large platelets and/or giant platelets. Is it OK to include a comment in the report that the platelets are adequate or that the count could be due to large platelets, especially with values that indicate marked thrombocytopenia? Read answer.

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Put It on the Board

April 2021—In an Association for Molecular Pathology survey focused on molecular testing in oncology during the pandemic, 70 percent of 163 respondents reported having decreased or stopped the development and validation of new tests in their laboratories.

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From the President’s Desk: Lab quality in times of COVID-19

March 2021—I inspected my first lab as a pathology resident in 1988. Robert Baisden, MD, head of clinical pathology at Medical College of Georgia at the time, handed me a checklist one day and said we were going to do a laboratory inspection. Like that of so many pathologists, my introduction to the CAP came through the Laboratory Accreditation Program. The Laboratory Improvement Program, LIP, is an essential component in the CAP’s efforts to ensure laboratory quality.

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Q&A column

Q. In our hospital, respiratory therapy runs most of the blood gas tests on instruments in centralized locations. Staff are able to enter into the blood gas instrument, which is connected to the LIS, to whom they gave critical results. However, staff do not have a way to document that a result was read back. The majority of these critical results happen in the neonatal intensive care and intensive care units, where respiratory therapy is a part of the care team, so results are given in person. Is documenting a read-back necessary when critical results are communicated verbally? How does the CAP checklist COM.30100 relate to point-of-care testing? Read answer.

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Clinical pathology selected abstracts

March 2021—Convalescent plasma, with neutralizing and non-neutralizing anti-viral antibodies, has been used to treat COVID-19 patients. Plasma is collected from people who have recovered from the disease and transfused to those who are infected. Data have shown improvements in patients with severe infections who are transfused with COVID-19 convalescent plasma. The majority of people who have COVID-19 will demonstrate IgM and IgG antibodies within two weeks of symptom onset. These antibodies have specificity toward the receptor-binding domain (RBD) and spike protein viral epitopes that correspond to virus neutralization.

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Anatomic pathology selected abstracts

March 2021—Prostatic-type differentiation in the lower female genital tract is rarely encountered and its causes and clinical associations are not well established. Reports have invariably described ectopic prostatic-type differentiation within the vagina as restricted to the lamina propria. The authors encountered a patient receiving testosterone for gender dysphoria whose vaginectomy specimen showed a prostatic glandular proliferation within the surface epithelium. To elucidate its potential association with androgen exposure, they sought similar lesions, resected during a 26-year period, from patients with exogenous or endogenous androgen excess. Thirteen cases, involving the vagina (n =12) and exocervix (n =1), were identified.

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Pathology informatics selected abstracts

March 2021—A significant benefit of whole slide imaging is the ability to view digital slides remotely. This benefit has been reinforced during the COVID pandemic as pathologists render pathology diagnoses from home. At the same time, the FDA has temporarily relaxed regulations for modifying FDA-cleared digital pathology devices and the marketing of devices that are not FDA 510(k) cleared. This contrasts with previous requirements that various digital pathology systems use computer displays with specifications that have satisfied regulatory or institutional approval, or both. This, in turn, raises concern about pathologists working in unregulated home settings where they use a variety of monitors that vary in visual quality and, therefore, in image clarity.

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Molecular pathology selected abstracts

March 2021—High tumor mutational burden in certain cancers has become an established biomarker for predicting a response to immune checkpoint inhibitor therapy and longer overall survival after such treatment. The immune checkpoint inhibitor (ICI) pembrolizumab, for example, has recently been approved by the FDA for patients whose solid tumors, regardless of histology, have a high tumor mutational burden (TMB), defined as 10 or more mutations per megabase. TMB, assessed by next-generation sequencing, varies considerably among cancers and can range from 0.01 to more than 1,000 somatic mutations per megabase of sequenced genome. The presumed mechanism for the enhanced responsiveness to immunotherapy associated with high TMB is the creation, by somatic mutation, of potentially immunogenic neoantigens that facilitate an enhanced antitumor immune response. Given this presumed mechanism, the authors addressed whether high TMB levels, which are associated with better cancer outcomes in patients treated with immune checkpoint inhibitors, might also lead to better outcomes for patients treated with other anti-cancer therapies.

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Newsbytes

March 2021—For many pathologists, smartphones are an untapped resource. Although the screen is significantly smaller than a computer display, the device offers much of the same functionality to enhance the practice of pathology as its larger cousin but with the benefit of pocket portability.

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Put It on the Board

March 2021—As the U.S. fights COVID-19 and prepares for new threats, its leaders need to “motivate and support a laboratory-based testing model that enables broad and distributed production capacity,” say the authors of a “Perspective” published Jan. 21 in the New England Journal of Medicine (2021;384[3]:197–199).

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From the President’s Desk: Important wins but work continues

February 2021—In late December, the U.S. Congress passed a COVID-19 relief bill that included two key items for pathologists—measures that the CAP pushed hard to achieve on our behalf. The document is more than 5,000 pages and addresses a large number of subjects, including thoroughbred horses. Here, I’d like to offer a brief analysis of the elements that affect our profession.

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Clinical pathology selected abstracts

February 2020—SARS-CoV-2 is transmitted through respiratory droplets, close person-to-person contact, and infected surfaces. Those with COVID-19 often present with fever and respiratory symptoms, and diagnosis relies on detecting the virus through specimens from the upper and lower respiratory tract. However, an increasing number of patients are exhibiting such gastrointestinal symptoms as diarrhea, vomiting, and abdominal pain. A growing number of studies are reporting the presence of SARS-CoV-2 RNA in stool samples and anal swabs, generating interest in research focused on a fecal-oral route of transmission. The authors conducted a study to assess the clinical relevance of testing stool samples and anal swabs for SARS-CoV-2 and to provide a critical overview of literature addressing possible fecal-oral transmission.

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Anatomic pathology selected abstracts

February 2021—SARS-CoV-2 primarily causes pulmonary injury, but it has been implicated in hepatic injury through the use of serum markers and histologic evaluation. The histologic pattern of injury has not been completely described, and studies quantifying viral load in the liver are lacking. The authors conducted a study in which they reported the clinical and histologic findings related to the liver in 40 patients who died of complications of COVID-19. For the study, they subjected a subset of liver tissue blocks to polymerase chain reaction (PCR) for viral RNA. Peak levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were elevated, with a median ALT peak of 68 U/L (normal up to 46 U/L) and median AST peak of 102 U/L (normal up to 37 U/L). Macrovesicular steatosis was the most common finding, involving 30 (75 percent) patients.

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Molecular pathology selected abstracts

February 2021—Beta-thalassemia and sickle cell disease are common hereditary conditions that can have life-threatening complications. Both diseases are caused by genetic alterations affecting the beta subunit of hemoglobin. Mutations that reduce or prevent the synthesis of the beta-globin protein cause beta-thalassemia, a disease characterized by inadequate red blood cell production and, therefore, anemia. In contrast, sickle cell anemia results from a specific point mutation in the beta-globin gene that causes the resulting protein to polymerize. These protein polymers form rigid fibers that affect the stability of the red blood cell and cause its characteristic sickling deformity. Destruction of the aberrant red blood cells leads to anemia, and the sickled cells can also cause painful vaso-occlusive episodes and tissue damage.

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From the President’s Desk: Celebrating 75 years

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.

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Clinical pathology selected abstracts

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.

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Anatomic pathology selected abstracts

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.

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Molecular pathology selected abstracts

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.

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Pathology informatics selected abstracts

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.

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Newsbytes

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.

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From the President’s Desk: The year that wouldn’t end

December 2020—As we reach the end of December, I am taking a look back at this year and wondering: How long was 2020 anyway? My calendar says 12 months, but if you’re like me, 2020 seems like it has already had about 24 in it and I’m still counting. I’ve even taken to using “2020” as an expletive. When I think of the key themes of the past year, most are quite negative. The pandemic, virtual meetings, and extremely challenging legislation just to name a few. In the spirit of hoping the worst is behind us—and to remind ourselves how much we worked to make the best of a bad situation—let’s take a quick tour of the major difficulties we faced in 2020.

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Clinical pathology selected abstracts

December 2020—The National Academy of Medicine estimated that approximately 30 percent of U.S. health care spending constitutes nonvalue-added waste. This waste may be generated through unnecessary laboratory tests and services, inefficiency of care delivery, ex­cessive administrative costs, and high prices. A goal of medical educators is to inform undergraduate medical students about health care management and health care delivery to make them better stewards of cost-effective, high-value care (HVC). The authors described the results of a needs analysis to inform the design of an online case-based educational tool for teaching laboratory stewardship to medical students. To this end, they conducted a needs assessment that included semi-structured interviews of core clerkship directors and residency program directors, a national survey of the Undergraduate Medical Educators Section of the Association of Pathology Chairs, and a review of existing online resources for teaching HVC. Their results showed that all of the core clerkship directors and residency program directors thought that teaching laboratory stewardship as part of the undergraduate medical education (UME) curriculum was important. The two major themes that emerged from the analysis to enhance laboratory stewardship education were appropriate test ordering and interpretation. The authors also found several organizations that provide HVC education through online modules or clinical cases.

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Anatomic pathology selected abstracts

December 2020—It can be difficult to distinguish metastatic melanoma from melanocytic nevi in lymph nodes. Because diffuse IHC PRAME (preferentially expressed antigen in melanoma) expression is detected in the majority of primary and metastatic melanomas, but rarely in nevi, the authors conducted a study in which they hypothesized that PRAME could be a useful adjunct marker for the diagnosis of melanocytes in lymph nodes. They examined 45 nodal melanocytic deposits comprising 30 nodal nevi and 15 melanoma metastases. The latter were not straightforward from a diagnostic perspective because they coexisted with nodal nevi or were present in perinodal fibrous tissue. All nodal nevi were negative for PRAME and all melanoma metastases were diffusely positive for PRAME IHC.

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Molecular pathology selected abstracts

December 2020—Next-generation sequencing-based mutation testing of various cancer types is clinically indicated and widely used to diagnose disease, inform potential therapeutic targets, prognosticate disease course, and monitor responses to targeted and nontargeted therapies. The genetic variants discovered by tumor-based next-generation sequencing (NGS) can be somatically acquired by the neoplastic cells or a fixed inherited component of the patient’s germline genome. Distinguishing the germline versus somatic status of tumor NGS-defined variants is of significant clinical importance not only for patient care but possibly for patients’ families. Because many cancers have a substantial inherited component, the discovery of a pathogenic germline mutation by tumor-based NGS may have substantial familial implications. For example, being aware of a cancer risk allele, such as BRCA1, can lead to the use of highly effective interventions to prevent or treat the related cancer in family members. Consensus guidelines recommend germline genetic testing only for those cancer patients who have a clinical presentation or family history suggestive of hereditary disease.

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Newsbytes

New NovoPath CEO settled in and taking questions December 2020—CAP TODAY publisher Bob McGonnagle recently spoke with Promise Okeke, who took the helm as CEO of NovoPath last summer. Here’s what Okeke had to say about NovoPath’s case distribution module, customer service, and the advantages of offering a best-of-breed system, among other topics.

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Put It on the Board

December 2020—Antimicrobial Susceptibility Testing: Monitoring and Trend Analysis is a new CAP program that is beginning to roll out to laboratories this month. The CDC guidance for antibiotic stewardship consists of seven core elements to address resistance-associated risks, one of which points to the importance of laboratory collaboration, communication, and AST reporting practices to the success of stewardship programs. According to this core element, the laboratory must provide information to guide discussions on the potential implementation of test interpretive criteria, such as changes in antibiotic breakpoints, that might affect antibiotic use.

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Clinical pathology selected abstracts

November 2020—Smoking is a leading cause of death in the United States and is associated with many postoperative complications, including increased transfusion needs. Toxins in tobacco that create free radicals that damage the arterial walls and make them more susceptible to rupture and bleeding may be the link between smoking and surgical bleeding. Smoking also impairs tissue healing after surgery, most likely due to reduced oxygenation and altered function of inflammatory cells during the healing process. This may impact bleeding risk in the immediate postoperative period. The authors conducted a study in which they queried the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) Participant Use Data File 2007–2016, which contained data from up to 680 U.S. hospitals, to test the hypothesis that smoking is associated with a higher risk of bleeding in various surgical procedures.

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Molecular pathology selected abstracts

November 2020—Sporadic vascular malformations are congenital malformations of arteries, veins, capillaries, or lymphatic vessels, or a combination of these, and are associated with significant morbidity. The majority of them are caused by postzygotic somatic pathogenic variants in oncogenes in the PI3K-MTOR and RAS-MAPK pathways, including within PIK3CA, TEK, MAP2K1, BRAF, and KRAS. Investigators have assessed whether therapeutic agents targeting these pathways should be used to augment or replace traditional surgical management. But because these somatic variants are restricted to cells within the tissue of vascular malformations (VM), it is necessary to conduct genetic testing on the surgically resected tissue to qualify patients for trials of targeted therapies. Approximately 10 percent of cell-free DNA (cfDNA) originates from endothelial cells.

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Anatomic pathology selected abstracts

November 2020—Neuroendocrine neoplasms range from well to poorly differentiated and indolent to highly aggressive. The site of origin in metastatic neuroendocrine neoplasms has therapeutic and prognostic implications. SATB2 is a transcriptional regulator involved in osteoblastic and neuronal differentiation and a sensitive and specific marker of colorectal epithelium. The authors conducted a study to evaluate the expression of SATB2 in neuroendocrine neoplasms from various primary sites and its utility as a marker for determining the site of origin of these neoplasms. SATB2 IHC was performed on 266 such neoplasms, including lung small cell carcinomas (n = 39) and carcinoids (n = 30), bladder (n = 21) and prostate (n = 31) small cell carcinomas, and gastrointestinal/pancreatic neuroendocrine neoplasms of various primary sites (n =145) consisting of well-differentiated neuroendocrine tumors (WDNET, n =124) and poorly differentiated neuroendocrine carcinomas (PDNEC, n = 21).

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Pathology informatics selected abstracts

November 2020—Telepathology is a leading application for digital pathology. The ability to easily share a digital image in practice offers pathology laboratories clinical, operational, and financial benefits. This is best demonstrated by the longstanding success of telepathology in allowing pathologists to remotely perform intraoperative consultations—that is, to read frozen sections. Neuropathologists were one of the first specialists to leverage digital pathology for this clinical use. The authors, all of whom were from the University of Pittsburgh Medical Center, performed teleneuropathology at their institution, which implemented the practice 17 years ago.

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Newsbytes

November 2020—As LigoLab was designing a direct-to-consumer portal for laboratory testing early this year, company CEO Suren Avunjian turned his focus to when in 2021 he would release it, not knowing what was around the corner. But as the number of COVID-19 cases grew to pandemic proportions, Avunjian realized he could and should redesign the portal to streamline SARS-CoV-2 testing.

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Put It on the Board

November 2020—In an Association for Molecular Pathology survey, 62 percent of U.S. labs reported using only commercial testing kits with FDA EUA for SARS-CoV-2 molecular testing. Five percent reported using laboratory-developed tests only, 26 percent said they were using a combination of LDTs and EUA commercial kits, and six percent reported using LDTs, IRB-approved/non-EUA assays, and commercial kits. Less than one percent reported using a combination of LDTs and IRB-approved/non-EUA assays or a combination of IRB-approved/non-EUA assays and commercial kits.

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Clinical pathology selected abstracts

October 2020—Early in the COVID-19 pandemic, some reports linked ABO blood type to severity of the disease and test positivity. Among these were reports that blood type A was associated with a higher risk for SARS-CoV-2 infection and blood group O with a lower risk of infection and mortality. However, there is a paucity of data regarding the relationship between ABO blood type and severity of COVID-19. Therefore, the authors conducted a large multi-institutional observational study to determine if there is an association between ABO blood type and severity of COVID-19 and if those with specific blood types are more likely to test positive for the disease. For the study, they used a large multi-institutional database of adult patients who tested positive for SARS-CoV-2 at five major hospitals in Massachusetts from March 6 to April 16. The authors evaluated hospitalization, intubation, and death for an association with blood type.

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Anatomic pathology selected abstracts

October 2020—Immune checkpoint inhibitors are frequently used to treat a variety of solid tumors. These drugs involve upregulation of cytotoxic T cells, which can lead to immune-related adverse events, including those involving the gastrointestinal tract. The authors conducted a study to characterize the histological features of immune checkpoint inhibitor therapy-associated gastritis. Gastric biopsies from patients on immune checkpoint inhibitor therapy who had clinical suspicion of drug-associated gastrointestinal injury were identified. The predominant histological pattern of injury, distribution of injury, degree of tissue eosinophilia, and prominence of apoptosis were recorded.

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Molecular pathology selected abstracts

October 2020—An increase in the number of copies of a gene, or amplification, is regarded as the most common gain-of-function alteration across various cancer types. The authors developed a bioinformatics tool (Amplicon Architect) to identify extrachromosomal oncogene (ecDNA) amplification from whole genome sequencing (WGS) data based on three characteristic features: circularity of ecDNA, absence of a centromere, and high levels of amplification. The tool was validated in 44 cancer-derived cell lines known to have ecDNA. A combination of centromeric and noncentromeric FISH probes was used to identify extrachromosomal DNA, and the tool was able to classify 83 percent of these signals as representing circular ecDNA amplicons. Interestingly, some of these cases revealed the presence of concurrent extrachromosomal and intrachromosomal signals, suggesting that some ecDNA had reintegrated into the genome.

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Newsbytes

October 2020—Many prolific Twitter users describe the social media site as a time sink, but Andrew Schaumberg, PhD, begs to differ. After observing pathologists turn to Twitter to seek advice about difficult patient cases, he developed Pathobot, a free, artificial intelligence-driven search tool on Twitter that is designed to help pathologists connect with colleagues faster.

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Clinical pathology selected abstracts

September 2020—The clinical features and immune responses of people infected with SARS-CoV-2 who are asymptomatic are under investigation since people without disease symptoms can unknowingly spread the virus. As of Aug. 3, there were 17,965,128 confirmed COVID-19 cases worldwide, 4,749,138 of which were in the United States. The majority of those with SARS-CoV-2 infection have mild to severe respiratory illness with fever, cough, and shortness of breath, which appears two to 14 days after exposure. The authors conducted a study in which they described the epidemiological and clinical characteristics, viral levels, and immune responses in 37 asymptomatic people to better understand the clinical features and immune responses of people who are infected with SARS-CoV-2 and asymptomatic. The 37 asymptomatic people, all in the Wanzhou district of China, were diagnosed with RT-PCR–confirmed SARS-CoV-2 infections but had no relevant clinical symptoms in the preceding 14 days or while quarantined at the government-designated hospital for centralized isolation in Wanzhou.

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Anatomic pathology selected abstracts

September 2020—Identifying patients who respond to immune checkpoint blockade is a significant challenge in oncology. PD-L1 expression by immunohistochemistry is the diagnostic gold standard for patient selection, but it does not capture all patients who may respond to immune checkpoint blockade (ICB). Recent gene-expression studies of high-grade serous ovarian carcinoma have defined an immunoreactive molecular subtype that shows a measurable favorable difference in patient survival compared with nonimmunoreactive subtypes, but no studies have demonstrated its impact on predicting response to ICB. As a step toward establishing the predictive value of gene-expression classifiers in ICB, the authors assessed the relationship between PD-L1 IHC and molecular subtypes of ovarian epithelial cancer. They analyzed 93 tissue specimens from patients with stages III and IV disease and compared PD-L1 IHC with gene expression by Agilent microarrays using The Cancer Genome Atlas-defined subtypes.

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Molecular pathology selected abstracts

September 2020—Whole genome methylation profiling is used to subclassify neuroepithelial tumors and soft tissue sarcomas. Extending its use to much more common cancers, such as prostate cancer, has the potential to benefit a large number of patients. Metastatic castration-resistant prostate cancer (mCRPC) is the incurable and lethal form of prostate cancer and consists of different subgroups with variable morphologies and genomic alterations. The emergence of distinct subtypes of mCRPC likely represents adaption of the cancer cells to treatment and the microenvironment. The authors conducted a study that integrated methylation profiling with genomic sequencing and RNA transcriptome analysis in 100 mCRPC tumors, yielding a comprehensive molecular profile of these metastatic tumors.

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Pathology informatics selected abstracts

September 2020—Whole slide imaging has been available for clinical, research, and educational use for decades, with several digital pathology systems cleared by the FDA for primary diagnosis. However, widespread adoption of this technology for routine practice has been slow. Likely reasons for the slow uptick in employing whole slide imaging (WSI) for sign-out include the cost of these systems, their lack of interoperability with laboratory information systems, pathologist resistance to using this digital modality, and regulatory restrictions on remote sign-out imposed by the Clinical Laboratory Improvement Amendments (CLIA). However, the COVID-19 pandemic led the Trump administration, on March 26, to temporarily waive these CLIA regulations, giving pathologists the flexibility to sign out cases digitally from their homes.

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Q&A column

Q. Is the evaluation of gene copies by RT-PCR or multiplex ligation-dependent probe amplification a qualitative or quantitative assay? Copy number analysis of genes or chromosomes determines a numerical value, with a normal autosomal count being two. However, an FDA-approved microarray test (CytoScan Dx assay, Thermo Fisher Scientific) is labeled as a qualitative assay for the detection of copy number variations. Read answer. Q. How does using sodium heparin, in an attempt to reduce EDTA-induced platelet clumps, affect the platelet count? Read answer. Q. How do you know whether thyroid-stimulating hormone isoforms have been measured in an assay when the TSH levels are very high and free T4 is considerably less than the reference interval (i.e. less than 50 percent of the reference interval)? Read answer.

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Newsbytes

September 2020—While the SARS-CoV-2 outbreak has led many long-standing companies to zig instead of zag, it caused the computational and digital pathology startup Crosscope to switch gears in the midst of developing its first product.

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Put It on the Board

Roche launches Preanalytical System, announces FDA OK for HER2 Dual ISH test as CDx
September 2020—Roche launched its Cobas Prime Preanalytical System to improve efficiency in molecular diagnostics laboratories. It is now commercially available in the United States and markets accepting the CE mark. The system is designed to automate all preanalytic steps and features cross-contamination control of samples. It has track-connectable modular configurations with one workflow for multiple sample types, end-to-end automation with predictable lab turnaround time, and IT integration with sample and test tracking.

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From the President’s Desk: Virtual meetings, for now

August 2020—In the past six months, many of us have developed video conferencing skills to an extent we never imagined we would need. Until the COVID-19 pandemic led to lockdowns in several states, a great deal of expertise in Zoom and other similar platforms was not a high priority among many pathologists. I am proud that our community adapted quickly and skillfully to continue providing the best care possible to our patients.

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Clinical pathology selected abstracts

August 2020—Bacterial contamination of platelets continues to be an important cause of transfusion-associated morbidity and mortality. From 2001 to 2016, there were 51 deaths reported to the FDA due to transfusion of apheresis products contaminated with bacteria, including 30 deaths since testing for bacterial contamination was mandated in 2004. This mandate was implemented through primary culture of single-donor apheresis platelets in 2004 and then prestorage pooled platelets (PSPPs) in 2007. The authors conducted a study to compare the platelet bacterial contamination and septic transfusion rates before and after introducing testing of pooled and apheresis platelets by primary culture over an extended time period. They cultured platelet aliquots at issue and evaluated transfusion reactions.

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Anatomic pathology selected abstracts

August 2020—The authors conducted a study in which they reviewed 354 cases of malignant diffuse mesothelioma in women from a database of 2,858 histologically confirmed cases. Pleural predominance was noted with 78 percent of pleural malignant mesotheliomas (MM) and 22 percent of peritoneal MM. The pleural tumors consisted of 72 percent epithelioid, 19 percent biphasic, and nine percent sarcomatoid variant. The peritoneal tumors consisted of 82 percent epithelioid, 13 percent biphasic, and five percent sarcomatoid. The immunohistochemical profile was typical of what is well accepted and previously described for MM.

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Molecular pathology selected abstracts

August 2020—Patients and families suspected of having Mendelian diseases, syndromes thought to be caused by a single mutated gene, often undergo comprehensive next-generation sequencing to determine the underlying pathogenic variant. Whole exome sequencing, in which the coding regions of all genes are analyzed, is usually the preferred testing method. However, this identifies the diagnostic pathogenic variant in only 25 to 52 percent of cases. Whole genome sequencing appears to confer only marginal benefit over whole exome sequencing, presumably because the pathogenic variants likely are not missed by whole exome sequencing but may be misinterpreted as nondiagnostic. Among the variants that are difficult to interpret are those that affect RNA by directly influencing transcription, or altering normal splicing, or by mediating their effects through chromatin.

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Q&A column

Q. If a person died from an overdose, would the toxicology screen always show which drugs were in their system? Read answer. Q. We are looking into using a scale to measure 24-hour urine samples, but we can’t find much literature about it. Is the variation between the measurement from a scale and actual volume clinically significant? What kind of validation is recommended? Read answer.

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Newsbytes

August 2020—At Sonora Quest Laboratories, working backward has been a key strategy for leaping forward. Little by little, the Arizona-based integrated laboratory system has been retracing paper trails and assessing established processes as part of an ambitious plan to eliminate paper use across its seven commercial laboratories, 28 hospital labs, and more than 75 patient service centers.

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August 2020—SpIntellx and CellNetix Pathology & Laboratories will collaborate to validate the SpIntellx HistoMapr-Breast Platform. The platform is the first in the companies’ larger efforts to use explainable artificial intelligence-assisted lab processes in the development of diagnostics, prognostics, therapeutic strategies, and drug development for tumor and non-tumor diseases.

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Clinical pathology selected abstracts

July 2020—The College of American Pathologists launched the Pathology and Laboratory Quality Center for Evidence-Based Guidelines in 2009 to develop and promote laboratory practice guidelines (LPGs) using the National Academy of Medicine’s (NAM) standards for developing trustworthy guidelines. The center has published 17 evidence-based LPGs, including updated versions, using NAM’s criteria. In 2013, the CAP was awarded a five-year cooperative agreement grant from the Centers for Disease Control and Prevention to increase the effectiveness of its LPGs. The intent of the agreement was to assess awareness and adoption of two CAP LPGs: IHC assay validation (IHC VAL) and initial workup of acute leukemia (AL).

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Anatomic pathology selected abstracts

July 2020—Smooth muscle tumors represent the second most common mural mesenchymal neaoplasm in the gastrointestinal tract, yet established criteria for prognostically assessing these tumors are lacking. The authors conducted a study on a large cohort of surgically resected intramural gastrointestinal smooth muscle tumors from 31 institutions to identify potential prognostic features. At each location, expert gastrointestinal or soft tissue pathologists, or both, assessed pathologic features. IHC confirmation was required.

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Molecular pathology selected abstracts

July 2020—Drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms (DiHS/DRESS) is a rare but well-known full-body inflammatory skin condition that leads to life-threatening complications if untreated. The authors conducted a case study that involved a 44-year-old male who developed DiHS/DRESS after taking the combined antibiotic trimethoprim-sulfamethoxazole. Following standard treatment for this condition, the patient was started on high-dose prednisone, which provided no benefit. Subsequent tapering of prednisone advanced the disease to a toxic epidermal necrolysis-like condition. The patient was then given etanercept and high-dose intravenous immunoglobulin, without benefit. Next, the patient received cyclosporine, which resulted in some improvement but led to uncontrollable renal hypertension.

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Q&A column

Q. Is it acceptable for a clinical laboratory to calculate ionized (free) calcium if calcium ion-selective electrode is not available? Are results of calculated ionized (free) calcium of acceptable accuracy in clinical practice? And what is the recommended formula for performing this calculation? Read answer. Q. Under checklist requirement COM.04250 “Comparability of Instruments and Methods —Nonwaived Testing,” what is the minimum number of samples that should be analyzed and which acceptance criteria should be used for the comparison? In addition, what parameters in the complete blood count do not apply for comparison purposes? Read answer. Q. I read an article about phlebotomy that stated for proper patient care, the recommended maximum number of blood draw attempts is four. The hospital at which I work recently implemented a procedure in which the nurses perform blood draws, instead of laboratory personnel. The procedure requires a nurse to attempt a blood draw twice and, if not successful, ask another nurse, and then ask the nursing supervisor before finally calling the laboratory. This policy has been difficult for hospital staff, and I feel terrible for patients who get stuck numerous times. Can you provide feedback that I can use to express my concerns to hospital administration? Read answer.

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Newsbytes

July—In the early days of the COVID-19 pandemic, when the University of California, Berkeley's Innovative Genomics Institute decided to rapidly shift gears from conducting research to testing the community for SARS-CoV-2, some insiders may have thought the university was biting off more than it could chew under a tight timeframe. Yet a look at the lab 23 days later surely had any doubters eating their words.

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AMP recommends PGx alleles for genotyping testing for warfarin response July 2020—The Association for Molecular Pathology published in May consensus, evidence-based recommendations to aid in the design, validation, and interpretation of clinical genotyping tests for the prediction of warfarin response. The new guideline on clinical warfarin sensitivity genotyping allele selection completes a series of three reports intended to facilitate testing ...

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From the President’s Desk: Getting through the pandemic

June 2020—Like so many CAP TODAY readers, I have been spending the vast majority of my time working on COVID-19. In Georgia we have the dubious distinction of having a county with one of the highest per capita death rates due to COVID-19 in the country—at least as of early May when I wrote this. Things are moving so fast with this pandemic that by the time you read this, much will have changed.

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Clinical Pathology Selected Abstracts

June 2020—More than 1.7 million new diagnoses of cancer occur in the United States each year, and they are almost exclusively made by pathologists who evaluate patient specimens and issue a written diagnostic report. These patients often are not given the opportunity to talk with the pathologist who made the diagnosis or view their tissue through a microscope. There is little published data on patient-pathologist consultation programs in which patients can review their reports and slides with the pathologist. In addition, the number of patients who may be interested in this service is not known. The authors conducted a study to quantify patients’ interest in patient-pathologist consultation programs and qualitatively analyze their motivations for interest or disinterest.

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Anatomic Pathology Selected Abstracts

June 2020—The authors conducted a study in which they independently evaluated the utility and prognostic value of tumor budding according to International Tumour Budding Consensus Conference (ITBCC) criteria in a large well-characterized European gastric cancer cohort. They assessed tumor budding according to the ITBCC criteria for 456 consecutive, surgically treated gastric cancers using the scoring system Bd0 (no buds), Bd1 (one to four buds), Bd2 (five to nine buds), and Bd3 (10 or more buds). Cases with tumor budding were divided into low-budding (Bd1/Bd2) and high-budding (Bd3) groups. The tumor budding score was analyzed in relation to clinicopathological parameters, overall survival, and tumor-specific survival. The authors found that 115 (25.2 percent) cases had no tumor budding, 104 (22.8 percent) had low tumor budding, and 237 (52 percent) had high tumor budding.

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Molecular Pathology Selected Abstracts

June 2020—The COVID-19 pandemic has focused the world’s attention on using sensitive high-throughput molecular diagnostic testing for the SARS-CoV-2 virus as a public health tool for “flattening the curve” of the infection. Although initial shortages of specialized polymerase chain reaction (PCR) testing reagents that plagued the early weeks of the pandemic have slowly improved (as of CAP TODAY press time), an obstacle to universal testing continues to be the first-step bottleneck of collecting respiratory tract samples for virus-specific reverse transcriptase-PCR (RT-PCR) testing. The traditional gold standard sample for COVID-19 testing has been a nasopharyngeal (NP) swab. However, nationwide shortages of NP swabs, personal protective equipment (PPE), and viral transport media have intermittently delayed the testing process. In an attempt to alleviate these critical sample-collection issues and promote more widespread testing, the medical community and other entities have been investigating alternative sample-collection procedures.

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Q&A column

Q. Are there high-specificity IHC stains for diagnosing mesothelioma that differ from those recommended in the “Guidelines for pathologic diagnosis of malignant mesothelioma: 2012 update of the consensus statement from the International Mesothelioma Interest Group”? Read answer. Q. For our hospital tissue and blood committee, we would like to expand the tissue component to look at more preoperative versus postoperative diagnoses (acute appendicitis, for example) and anything else that should be evaluated, such as adequacy of tissue and blood samples. Is there a resource that provides a list of tissue-related quality metrics that we can evaluate? Read answer.

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Newsbytes

June 2020—The global market for health care chatbots has been growing at a fairly rapid pace in recent years, but “COVID-19 is the thing that’s going to make chatbots mainstream,” says Greg Kefer, chief marketing officer at the chatbot company LifeLink Health. A 2019 Allied Market Research report, released just months prior to the COVID-19 pandemic, projected the health care chatbot industry would reach $345.3 million by 2026, a steep rise from 2018, when it garnered $116.9 million (www.allied​market​research.​com/healthcare-chatbots-market). But now, the COVID-19 pandemic has put into sharp relief one of the key value propositions of chatbots—unlimited scale, which means the timeline for adoption “just got massively compressed,” says Kefer, whose software-as-a-service company develops enterprise-level chatbots for large health care organizations.

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Better cancer diagnostics at core of Future of Pathology report June 2020—Leica Biosystems launched in April The Future of Pathology Expert Report written by an international panel of pathologists in consultation with health care executives, cancer stakeholders, and pathology leaders. In the report, each member of the panel—Tiffany Graham, MD, and Jerad Gardner, MD, in the U.S., and Bethany Williams, MBBS, PhD, and Matthew Clarke, MBBS, in the U.K.—addresses one of four subjects: pathology education, digital pathology and artificial intelligence, improving perceptions of pathology, and molecular pathology. The theme of the report (available at www.thefutureofpathology.com) is improving and transforming cancer diagnostics.

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Clinical research registry aims to answer crucial COVID-19 questions May 2020—A Healthcare Worker Exposure Response and Outcomes Registry was launched April 13 to unite health care workers in the U.S. for rapid-cycle research. The goals of the so-called HERO registry are to engage workers in a research community, understand their experiences, and track outcomes associated with caring for patients with ...

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From the President’s Desk: Heroes in the COVID-19 pandemic

May 2020—The most pressing topic in pathology today is the COVID-19 pandemic. Because this column must be written a few weeks before it is printed and delivered to readers, anything I write in April will be out of date by the time you see it. Numbers will be wrong, and comments on testing methodology will be obsolete. Instead, I’ll focus on the bigger picture. As we watch the world’s response to the pandemic, I am proud to be a physician and a pathologist. I am honored to work with phenomenal laboratory personnel, and this is by no means unique to me. Across the medical community, we have seen people come together for a shared mission in ways we have never experienced before. The demands on our laboratories are tremendous, and we are rising to the challenges of producing tests and directing therapies under conditions we have not seen before.

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Newsbytes

May 2020—Imagine the potential educational benefits of pathology residents being able to see the precise path that the eyes of experienced pathologists take as they scan a whole slide image. Preliminary research has suggested that showing residents visual representations of a pathologist’s eye-tracking movement overlaid over a whole slide image can impact how they learn, says Sharon E. Fox, MD, PhD, a pathologist at the Southeast Louisiana Veterans Healthcare System and associate director of research and development, Department of Pathology, Louisiana State University Health Sciences Center.

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Clinical Pathology Selected Abstracts

May 2020—Laboratory costs represent approximately three to four percent of overall health care expenses but drive 70 to 80 percent of decisions made by physicians. One way to control laboratory testing expenditures is through appropriate utilization. For example, thyroid and antinuclear antibody (ANA) testing have reliable initial screening tests, yet specialized testing is overutilized for both. In 2000 guidelines, the College of American Pathologists and American College of Rheumatology established that the ANA screen by immunofluorescence in the setting of a negative result is sufficiently sensitive not to perform further testing with subserologies and that thyroid-stimulating hormone (TSH) is a sensitive marker of thyroid function and can often be used without further testing with a normal TSH.

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Q&A column

Q. Can you provide a current reference for the various modifications of transfused red blood cells — for example, irradiation and white cell depletion — and their indications? Read answer. Q. In the context of allowable error relative to the immature platelet fraction test, is the analytical measurement range applicable to the IPF? Read answer. Q. What is the normal random plasma glucose value? Read answer.

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Anatomic Pathology Selected Abstracts

May 2020—Flat epithelial atypia is an alteration of terminal duct lobular units by a proliferation of ductal epithelium with low-grade atypia. No consensus exists regarding whether the diagnosis of flat epithelial atypia in core needle biopsy necessitates excision. The authors retrospectively identified all in-house core needle biopsies with flat epithelial atypia obtained at their institution between January 2012 and July 2018. They reviewed all core needle biopsy slides and assessed radiologic-pathologic concordance. An upgrade was defined as invasive carcinoma or ductal carcinoma in situ in the excision, or both. The excision slides of all upgraded cases were re-reviewed.

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Molecular Pathology Selected Abstracts

May 2020—Each year a growing number of novel viruses are discovered in the wild animal kingdom with the use of next-generation sequencing technology. However, the current method of functionally assessing the zoonotic potential—that is, the potential to be transmitted to humans—of novel viruses involves synthesis of viral genomes (tens of thousands of bases) and reverse genetic engineering to produce a recombinant virus. This is expensive and time-consuming, and it is not practical due to the scale of new viral strains being discovered. To overcome this hurdle, Letko, et al., developed a rapid and cost-effective method that could functionally assess a number of related viruses for zoonotic potential. The essential component of viral cross-species transmission is cell entry, which is a multi-step process involving attachment of the virus to the host cell surface, receptor engagement, processing of host proteases, and downstream membrane fusion.

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Q&A column

Q. For the population with diabetes, what can the clinical laboratory do to promote evidence-based testing and monitoring for chronic kidney disease? Read answer. Q. What are the proficiency testing enrollment requirements if an analyte is tested in multiple locations within the laboratory? Read answer. Q. With regard to specimens from oncology patients exhibiting hyperleukocytosis, the Beckman Coulter DxH 800 analyzer used by our laboratory autocorrects the RBCs, but the lab is still seeing errors on the indices (hemoglobin, MCV). What is the best way to correct for potential WBC interference on the RBC indices? Read answer.

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Ortho Clinical Diagnostics in February made available its Vitros XT 3400 Chemistry System.
April 2020—Ortho Clinical Diagnostics in February made available its Vitros XT 3400 Chemistry System. The new system, like the Vitros XT 7600 Integrated System, simultaneously performs two tests frequently ordered together on one Vitros XT MicroSlide. Double assay processing offers a 25 percent faster turnaround time on a common panel of assays, Ortho said in its Feb. 26 statement, with an average processing time of 7.5 minutes. The XT MicroSlide allows for a sample volume of 2.7 μL.

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From the President’s Desk: How the government influences your practice

April 2020—It is important for pathologists to understand just how much influence the federal government has on our practice of medicine. In last month’s column, I discussed ways in which the government dictates how and whether we are paid for our services. This month I’ll address the role of the federal government in determining where and how we practice. You probably already know that pathology labs are among the most highly regulated areas within health care, subject to regulations from multiple agencies.

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Newsbytes

R programming language gains steam in pathology labs April 2020—Among laboratories focused on expanding data analytics, the statistical programming language R has a loyal user base that is steadily growing. “There is a crew of us that are really trying to show the utility of R for laboratories,” says Stephen Master, MD, PhD, chief of the Division of Laboratory Medicine and director of the Michael Palmieri Laboratory for Metabolic and Advanced Diagnostics at Children’s Hospital of Philadelphia.

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Clinical Pathology Selected Abstracts

April 2020—An outbreak of pneumonia occurred in Wuhan, Hubei province, China, in December 2019. A novel coronavirus was identified as the causative agent and named SARS-CoV-2 by the World Health Organization (WHO). The disease, COVID-19, is considered a relative of severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). SARS-CoV-2–infected patients presented with a dry cough, dyspnea, fever, and bilateral lung infiltrates.

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Anatomic Pathology Selected Abstracts

April 2020—Lymphocytic esophagitis is a well-known manifestation of Crohn disease among children but is not considered an immune-mediated mucositis in adults. The authors conducted a study for which they hypothesized that adult-onset lymphocyte-predominant esophagitis is also an immune-mediated inflammatory pattern, the nature of which has been masked by other conditions that feature esophageal lymphocytosis and occur in older adults. The intent of the study was to consolidate diagnostic criteria for lymphocyte-predominant esophagitis and determine its clinical significance.

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Molecular Pathology Selected Abstracts

April 2020—Prior to the recent novel coronavirus outbreak, the vast majority of coronaviruses that were known to be pathogenic in humans caused mild symptoms, with the exception of two strains. These included SARS (severe acute respiratory syndrome coronavirus [SARS-CoV]) and MERS (Middle East respiratory syndrome coronavirus [MERS-CoV]). SARS was documented as having emerged in the Guangdong province in southern China in 2002 and having caused at least 774 reported fatalities worldwide, while MERS, which was first detected in Saudi Arabia in 2012, was responsible for at least 858 fatalities worldwide.

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From the President’s Desk: The federal government and your compensation

March 2020—It is important to understand that we—those of us who work in the U.S.—are all essentially independent contractors for the federal government. Pathologists who work directly for a federal agency or the Department of Defense are the only exception. The federal government has enormous influence on funding and reimbursement in health care. Including direct and indirect spending, about 50 cents of each health care dollar comes from Washington.

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Newsbytes

March 2020—At trauma hospitals, simplicity is considered a virtue. That’s why when Jansen Seheult, MD, and his colleagues decided to use machine learning to predict massive transfusion needs, they chose a decision tree algorithm. “It was easy to implement as if/then rules, and it didn’t require computational resources to deploy,” says Dr. Seheult, clinical assistant professor of pathology at the University of Pittsburgh Medical Center.

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Clinical Pathology Selected Abstracts

March 2020—U.S. guidelines for human papillomavirus vaccination are 11 to 12 years, with a catch-up vaccination up to age 26 for women and 21 for men. The FDA recently expanded the approved age for HPV vaccination in adult women and men from nine through 45 years. The changes are based on safety data and efficacy as well as potential incremental population-level health benefits. The authors conducted a study to evaluate the added population-level effectiveness and cost-effectiveness of extending the current U.S. HPV vaccination program to women ages 27 through 45 years and men ages 22 through 45 years. They used HPV-ADVISE (agent-based dynamic model for vaccination and screening evaluation), a model for HPV infection and associated diseases specific to U.S. data.

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Molecular Pathology Selected Abstracts

March 2020—Microsatellite instability status in solid tumors is a critical biomarker for predicting tumor response to an immune checkpoint inhibitor drug. The immune system is more likely to attack those tumors that have a high degree of microsatellite instability, a consequence of the genomic instability that also leads to generation of the neoantigens the immune system is designed to recognize.

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Anatomic Pathology Abstracts

March 2020—Conflicting data about the clinical significance of microscopic Crohn disease activity at resection margins have led to varying practice patterns for routine reporting by pathologists. The authors performed a multicenter retrospective cohort study of 101 consecutive Crohn disease bowel resections during a 10-year period to characterize the association between active disease at resection margins and postoperative Crohn disease recurrence and time to recurrence. Margin slides were reviewed, and Crohn disease activity at the margins was graded as none, mild, moderate, or severe. The authors used logistic regression and Cox regression analyses, respectively, to evaluate the association between microscopic Crohn disease activity at the margins and postoperative recurrence and time to recurrence.

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Roche, Illumina partner to broaden access to genomic testing
February 2020—Roche has entered into a 15-year, nonexclusive partnership with Illumina to broaden the adoption of distributable next-generation-sequencing–based testing in oncology. The agreement brings together the capabilities of both companies to broaden adoption of NGS in cancer care. As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic tests on Illumina’s NextSeq 550Dx system and on its future portfolio of diagnostic sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 with new companion diagnostic claims. The financial terms of the deal were not disclosed. Under the IVD terms of the agreement, Roche will develop, manufacture, and commercialize Avenio IVD tests for tissue and blood for use on Illumina’s NextSeq 550Dx. Illumina will continue to sell the NextSeq 550Dx systems and core sequencing consumables.

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From the President’s Desk: Our first Leadership Summit

February 2020—Regular readers of CAP TODAY know I believe that it is extremely important for CAP members to become politically active. The upcoming Pathologists Leadership Summit, which will take place May 2–5 in Washington, DC, will give you the opportunity to do so. If you haven’t registered already, I encourage you to consider attending this special event. The Pathologists Leadership Summit is new for the CAP. It is replacing our annual policy meeting focused on government advocacy.

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Newsbytes

Drone delivery of lab samples: from progress at WakeMed to interest elsewhere

February 2020—After nearly a year of a drone buzzing through the air to deliver specimens from the Raleigh Medical Park surgery center to the laboratory at the flagship Raleigh campus of WakeMed Health and Hospitals a quarter-mile away, WakeMed is looking to expand its drone program.

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Clinical Pathology Selected Abstracts

Blood utilization and transfusion reactions in pediatric patients transfused with platelets

February 2020—Even with advances in donor screening and infectious disease testing, the risk of transfusion-transmitted infections continues to be a concern. The FDA has approved a pathogen-reduction system for single-donor platelets, called Intercept Blood System (Cerus Corp.), to treat thrombocytopenic adult and pediatric patients.

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Anatomic Pathology Selected Abstracts

DNAJB1-PRKACA fusions in fibrolamellar hepatocellular carcinoma

February 2020—Recently discovered DNAJB1-PRKACA oncogenic fusions have been considered diagnostic for fibrolamellar hepatocellular carcinoma. The authors conducted a study in which they described six pancreatobiliary neoplasms with PRKACA fusions, five of which harbored the DNAJB1-PRKACA fusion.

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Molecular Pathology Selected Abstracts

Overall survival rates for lung cancer patients receiving osimertinib

Guidelines recommend testing patients with advanced or metastatic nonsmall cell lung cancer (NSCLC) for epidermal growth factor receptor (EGFR) alterations because targeted treatment with a tyrosine kinase inhibitor (TKI) is available for patients with EGFR exon 19 deletions or L858R point mutations. Osimertinib is a third-generation, irreversible, oral EGFR-TKI that selectively inhibits EGFR-TKI–sensitizing and EGFR p.Thr790Met-resistance mutations.

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Ion Torrent Genexus launched at AMP meeting
January 2020—Thermo Fisher Scientific launched at the Association for Molecular Pathology meeting in November its Ion Torrent Genexus System. It is a fully integrated, next-generation sequencing platform that features an automated specimen-to-report workflow, with results provided in a single day. The company also introduced its Oncomine Precision Assay, a pan-cancer panel for the Genexus platform, for comprehensive genomic profiling from formalin-fixed, paraffin-embedded tissue and liquid biopsy samples with a single assay. The Genexus System minimizes user intervention and the potential for human error. Thermo Fisher says the system requires minimal amounts of tissue sample and can run small batches cost-effectively to deliver a comprehensive report in one day. Together, the company said in a statement, “these features set the stage for molecular pathologists in the future to analyze NGS information in parallel with first-line testing modalities such as immunohistochemistry.”

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From the President’s Desk: What’s the state of your state pathology society?

January 2020—Recently I attended and spoke at a meeting of the Georgia Association of Pathology. That might not sound like a big deal, but it was. This was an important occasion for me and my colleagues in Georgia because our state society had been dormant for the past decade. Thanks to the efforts of five CAP fellows and the CAP itself, we are back in Georgia.

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Newsbytes

January 2020—Pathologist Ron B. Schifman, MD, practices what he preaches and preaches about what others practice relative to implementing such computer-based test-utilization management techniques as soft stops, hard stops, and those that fall in between. In a 2019 American Association of Clinical Chemistry presentation on strategies and tactics for test-utilization management, and in an interview with CAP TODAY, Dr. Schifman offered insights into a variety of information technology-based interventions.

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Clinical pathology selected abstracts

Use of thromboelastography to guide blood product transfusion
January 2020—Thromboelastography and rotational thromboelastometry provide insights into blood clot development, stabilization, and dissolution. The coagulation tests provide a tracing through the clotting process, but although they are similar, they are not interchangeable.

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Anatomic pathology selected abstracts

Distinct patterns of human liver regeneration following massive hepatic necrosis
January 2020—Massive hepatic necrosis is a rare and often fatal complication of various liver injuries. However, some patients survive by spontaneous hepatic regeneration. It is known that surviving hepatocytes or progenitor cells, or both, can participate in this process, but the mechanism of hepatic recovery is vague.

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Molecular pathology selected abstracts

Virtual staining of tissue slides to conserve precious diagnostic samples
January 2020—Precise classification of neoplasms improves risk stratification and the ability to apply targeted treatment options, enhancing patient care. These granular diagnostic classifications increasingly rely on molecular findings that go beyond what the microscope shows the pathologist.

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FDA grants de novo designation to NGS HIV-1 genotyping assay
December 2019—Vela Diagnostics received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations. The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M drug resistance mutations in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first HIV-1 genotyping NGS assay to receive marketing authorization from the FDA. In a Nov. 5 statement, Vela acting CEO and chairman of the board Sam Dajani called the FDA’s granting of the de novo designation to the NGS assay “a major milestone in HIV diagnostics.” “With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” he said. The assay is validated on the Sentosa NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting.

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From the President’s Desk: Looking ahead to 2020

December 2019—This time of year, it’s easy to find ourselves caught up in holiday planning and the challenges of managing a busy team’s hectic vacation schedule. But it is also the appropriate time to look ahead to the coming year and think about the opportunities as well as the challenges we should expect. Here’s what I can say for sure about next year and the years after that: The importance of pathologists and the laboratories that we direct will increase. Already, the majority of diagnoses and therapies are greatly influenced, if not outright dictated, by pathologists and our laboratories.

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Newsbytes

How a local startup solved a lab’s slide-management issues December 2019—When Alex Bushell, the young CEO of a Canadian startup, approached Bernard Schaan, the now-retired laboratory manager at Peterborough Regional Health Centre, in 2017, to ask what problem they might tackle together, Schaan mentioned an issue that had nagged him for years: histology slide filing and retrieval. Tasked with filing between 125,000 and 135,000 slides per year, “I thought the process could be automated and had been asking various sales reps if there’s anything out there—and they said no, there wasn’t,” Schaan says.

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Clinical pathology selected abstracts

Intraoperative red blood cell transfusion and mortality after cardiac surgery
December 2019—Patients with underlying cardiac disease are at risk for myocardial ischemia if they have untreated anemia at the time of cardiac surgery. During surgery, ongoing blood loss and hemodilution as a result of cardiopulmonary bypass (CPB) cause low hemoglobin levels. The optimal transfusion trigger for cardiac surgery patients continues to be debated. A more restrictive RBC transfusion strategy is used in patients with stable cardiovascular disease and is considered safe.

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Anatomic pathology selected abstracts

Evaluation of tumor quantitation as an aid in predicting biochemical recurrence in organ-confined prostate cancer
December 2019—In the eighth edition of the AJCC Cancer Staging Manual, all organ-confined disease is assigned pathologic stage T2, without subclassification. The authors investigated whether total tumor volume (TTV) or maximum tumor diameter (MTD) of the index lesion, or both, enhance the ability to predict biochemical recurrence in pT2 patients. They identified 1,657 patients using digital tumor maps and quantification of TTV/MTD who had pT2 disease on radical prostatectomy.

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Molecular pathology selected abstracts

Personalized oligonucleotide therapy for treatment of a rare genetic disease December 2019—A variety of molecular diagnostic laboratory tools are available to diagnose diseases caused by mutations in the human genome. However, few treatments are available to correct the underlying pathophysiology driven by these mutations. This is due, in part, to pharmaceutical companies’ inability to justify, from a business perspective, the expense and time necessary to develop and obtain FDA approval for novel therapies that benefit only a small number of patients.

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Illumina and Qiagen partner to deliver sequencing-based IVD tests
November 2019—Illumina announced on Oct. 7 a 15-year partnership intended to broaden the availability and use of NGS-based in vitro diagnostic kits, including companion diagnostics. The agreement grants Qiagen nonexclusive rights to develop and globally commercialize IVD kits to be used with Illumina’s MiSeq Dx and NextSeq 550Dx systems. The agreement also includes rights for expansion of the partnership on future Illumina diagnostic systems. Both partners are also exploring opportunities for Qiagen to develop and market companion diagnostics based on Illumina’s TruSight Oncology assays. Illumina and Qiagen will cooperate to commercialize a menu of clinically validated workflows that combine Qiagen’s proprietary content and bioinformatics solutions. The partnership will focus initially on commercializing oncology IVD kits and may expand in the future to include additional clinical diagnostic fields, such as cardiology, hereditary diseases, infectious diseases, and inflammatory and autoimmune diseases.

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Newsbytes

Francisco Partners to acquire Orchard Software
November 2019—Francisco Partners, a technology-focused private equity firm, announced Sept. 30 its intent to acquire Orchard Software. CAP TODAY publisher Bob McGonnagle, on Oct. 2, spoke with Orchard founder and CEO Rob Bush and with Billie Whitehurst, who will succeed Bush as CEO. Whitehurst most recently was senior vice president at Netsmart. Here is what they, and Curt Johnson and Kerry Foster, of Orchard, had to say about the acquisition.

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Clinical pathology selected abstracts

Intensive versus standard blood pressure control with cerebral white matter lesions
November 2019—The effect of intensive systolic blood pressure control on brain health is uncertain, despite its efficacy for reducing cardiovascular morbidity and mortality. However, hypertension is a primary risk factor for cerebral small vessel ischemic disease (SVID), especially in developing white matter lesions (WML). The pathogenesis of Alzheimer disease and related dementia is known to be associated with SVID and cognitive decline.

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Anatomic pathology selected abstracts

Angiosarcoma of the liver: clinicopathologic features and morphologic patterns
November 2019—Angiosarcoma is a rare malignant neoplasm of the liver for which morphologic patterns have not been systematically studied. To provide more comprehensive data on morphologic patterns, the authors reviewed angiosarcomas that had been diagnosed between 1996 and 2016 at a large medical referral center. The major growth patterns were classified as sinusoidal (nonmass forming) or mass forming.

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Molecular pathology selected abstracts

Tumor microbiome diversity 
and composition: influence on pancreatic cancer outcomes November 2019—Pancreatic adenocarcinoma has a dismal prognosis, with a high incidence of relapse and a median overall survival of 24 to 30 months. Only nine percent of patients are alive five years after surgery. Genome-wide mutational landscape studies to decipher the factors that contribute to long-term survival have been futile. Recent studies in patients with melanoma and lung cancer have shown that the gut microbiota can mediate tumor responses to chemotherapy and immunotherapy, influencing overall outcome.

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Sysmex joins Lab 2.0
October 2019—Sysmex America has joined the Clinical Lab 2.0 movement to support collaboration around value-based health care. The company said it is providing a grant focused on a multi-institutional demonstration project to develop actionable clinical strategies for anemia early detection, intervention, and prevention. Clinical Lab 2.0 is a Project Santa Fe Foundation initiative established to help develop the evidence base for the valuation of clinical laboratory services. It is a call for laboratory leadership in managing population health and enabling value-based care to evolve. Sysmex is the first corporate sponsor. “The Clinical Lab 2.0 movement, with its critical measurable and actionable attributes, promotes the clinical and business model of the future for clinical laboratories,” Khosrow Shotorbani, president and executive director of Project Santa Fe Foundation, said in a statement. The third annual Clinical Lab 2.0 Workshop will take place Nov. 3–5 in Chicago (www.cl2lab.org/clinical-lab-2-0-3rd-annual-workshop-registration-2-2/).

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From the President’s Desk: Why you need to be active in the CAP

October 2019—I have two goals as a pathologist, and I suspect that my colleagues share them. First, I want to be the best physician—the best pathologist—so I can give the best possible care to my patients. Second, I want to get paid fairly for the service I provide. Being the best pathologist comes with a number of requirements: staying up to date on the latest information and protocols, practicing in a quality lab, and working with great pathologists.

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Newsbytes

Digital health education: imperfect to imperative: October 2019—Arlen Meyers, MD, MBA, is a passionate advocate for educating medical students and practicing physicians about digital health technologies and their role in patient care. Without increased emphasis on organized digital health education, the medical field cannot fully embrace such technologies, says Dr. Meyers, president and CEO of the Society of Physician Entrepreneurs and co-editor of Digital Health Entrepreneurship, released this year by Springer Books.

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Clinical pathology selected abstracts

Cardiovascular events and mortality in white coat hypertension
October 2019—Hypertension is the most common preventable cause of disability and premature mortality worldwide. It is often diagnosed using in-office blood pressure measurements. More recent guidelines encourage out-of-office blood pressure monitoring, such as at-home self-monitoring, for diagnosing and managing hypertension.

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Anatomic pathology selected abstracts

Keratin 17: a sensitive and specific biomarker of urothelial neoplasia
October 2019—There is a clinical need to identify novel biomarkers to improve diagnostic accuracy for detecting urothelial tumors. The authors conducted a study to evaluate keratin 17 (K17), an oncoprotein that drives cell cycle progression in cancers of multiple anatomic sites, as a diagnostic biomarker of urothelial neoplasia in bladder biopsies and urine cytology specimens. The authors evaluated K17 expression using IHC in formalin-fixed, paraffin-embedded tissue specimens of nonpapillary invasive urothelial carcinoma (UC; classical histological cases), high-grade papillary UC (PUC-HG), low-grade papillary UC (PUC-LG), papillary urothelial neoplasia of low malignant potential (PUNLMP), and normal bladder mucosa.

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Molecular pathology selected abstracts

Circulating tumor DNA as a clinical test in resected pancreatic cancer
October 2019—Pancreatic ductal adenocarcinomas are associated with high rates of mortality due, in part, to a lack of effective screening strategies and advanced disease at diagnosis. Residual occult disease is thought to contribute to disease recurrence in up to 80 percent of patients treated surgically for localized disease. These findings highlight the critical need for biomarkers for detecting disease early and monitoring tumor dynamics. Current strategies involve a combination of serum markers (carbohydrate antigen [CA] 19–9) and imaging modalities, both of which have limitations, particularly for detecting early disease recurrence postoperatively.

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AACC panel votes Inflammatix technology most disruptive
September 2019—Inflammatix, a molecular diagnostics company, received the American Association for Clinical Chemistry’s Disruptive Technology Award at the AACC annual meeting in August. The company, in Burlingame, Calif., won for its rapid HostDx tests. The award was based on Inflammatix’s presentation during the meeting. It was one of three finalists selected to present to a panel of expert judges during a special session. “We’re developing rapid tests that read the immune system to improve disease diagnosis and are initially focused on developing tests for acute infections and sepsis, which are two of the biggest public health challenges of our time,” Tim Sweeney, MD, PhD, Inflammatix cofounder and chief executive officer, told CAP TODAY. The company’s first test, HostDx Sepsis, measures the expression of multiple immune genes to determine rapidly if a patient has a bacterial or viral infection and whether the patient has or is likely to develop sepsis, Dr. Sweeney said.

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From the President’s Desk: A summit, a park, and parting words

September 2019—The CAP will sponsor next May the Pathologists Leadership Summit in Washington, DC. This is not just another meeting where you’ll learn to deal with changes happening around you that feel as if they are out of your control. No. This is a radical reinvention of a meeting where members will come together to achieve something specific—and move pathology forward.

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Newsbytes

September 2019—It’s a simple and nearly airtight communication strategy: Tell someone something verbally and then share the same message with them in writing to make sure they understood you. Following this logic, a group of surgical pathologists at the University of Minnesota Medical Center made an assumption that if their intraoperative consultation results were made available to surgeons in written form during surgery as documentation of verbal communication—either in person or via telephone—the frequency of communication errors would be reduced.

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Anatomic pathology selected abstracts

Validation of 2016 ITBCC recommendations for tumor budding in stages I–IV colorectal cancer
September 2019—Tumor budding is a robust prognostic parameter in colorectal cancer and can be used as an additional factor to guide patient management. Although backed by large bodies of data, a standardized scoring method is essential for integrating tumor budding into reporting protocols.

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Molecular pathology selected abstracts

September 2019—The pathologist’s ability to interpret the complex spatial organization within and between cells and intercellular matrices is the basic underlying principle of morphologic pathology. Even in the genomic era, molecular genetic information is not clinically useful without tissue context. Modern spatial capturing methods, either by low-fidelity light microscopy or high-fidelity electron microscopy, cannot concomitantly interrogate a nucleic acid sequence.

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A heads-up on hybrid lab models of genetic testing
August 2019—Little attention has been paid to the emergence and effect of hybrid laboratories—those that fall in the middle ground between the direct-to-consumer and traditional models, say the authors of an opinion piece published in the June 25 issue of JAMA. Kathryn Phillips, PhD, Julia Trosman, PhD, and Michael Douglas, MS, of the Center for Translational and Policy Research on Personalized Medicine, University of California, San Francisco, say the emergence of the hybrid model, in which a clinician orders the test and returns results, “has significant implications for everyone involved in genetic testing,” providing potential benefits and risks.Greater access and convenience and lower cost for the consumer are among the potential benefits they list. Among the concerns: reduced continuity of care, profit motivation, and insufficiently extensive guidance and counseling. But there are other challenges with hybrid laboratories, they say.

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Clinical pathology selected abstracts

Editor: Deborah Sesok-Pizzini, MD, MBA, professor, Department of Clinical Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, and chief, Division of Transfusion Medicine, Children’s Hospital of Philadelphia. Financial impact of approaches to reduce bacterial contamination of platelet transfusions August 2019—The leading infection risk from blood transfusion is bacterial contamination, which is most likely due to the ...

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Anatomic pathology clinical abstracts

Evaluation of pan-TRK IHC in infantile fibrosarcoma, lipofibromatosis-like neural tumor, and histological mimics.
August 2019—Infantile fibrosarcoma is characterized by intersecting fascicles of spindle cells and ETV6-NTRK3 gene fusion in most cases. Given histological overlap with other spindle-cell tumors, the diagnosis can be challenging and often requires molecular confirmation. A recently developed pan-TRK antibody shows promise for identifying tumors with NTRK fusions.

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Newsbytes

August 2019—From concept to curriculum: PIER going strong five years later: In the five years since its launch, Pathology Informatics Essentials for Residents, or PIER, has continued to serve as a much-needed guide for pathology residents and program directors who otherwise would be navigating the waters of informatics training without a compass.

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From the President’s Desk—QI: rigor, precision, scope, and depth

August 2019—I am always interested in learning what is new in CAP laboratory improvement. My first inspection was some 40 years ago and our work in that realm has grown faster and gone further than I could have imagined back then.The CAP accredited its first laboratory in 1964 and published the first checklist several years later. I’m told that when Dennis B. Dorsey, MD (a then-future CAP president), submitted the first draft at 10 pages, his fellow LAP commissioners asked that he try to make it shorter.

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Molecular pathology selected abstracts

Editors: Donna E. Hansel, MD, PhD, chair of pathology, Oregon Health and Science University, Portland; Richard D. Press, MD, PhD, professor and director of molecular pathology, OHSU; James Solomon, MD, PhD, assistant professor, Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York; Sounak Gupta, MBBS, PhD, senior associate consultant, Mayo Clinic, Rochester, Minn.; Tauangtham Anekpuritanang, MD, molecular pathology ...

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AMP bolsters position on consumer genomic testing
July 2019—The Association for Molecular Pathology revised its position for all consumer genomic testing. Based on a recent assessment of the current market landscape and privacy best practices, the latest position statement features an expanded list of conditions that must be met before the AMP can support a clinically meaningful test. The AMP remains neutral to all recreational, novelty, and ancestry testing that may create educational opportunities for the public. The expanded set of conditions is as follows: • All health-related claims must have well-established clinical validity. • The consumer genomic testing provider must comply with the CLIA statute and regulations. Test validation and interpretation should be performed by board-certified molecular laboratory professionals. • Information regarding the analytical and clinical validity of the tests should be present in all marketing materials and included in each report of results.

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Q&A column

Q. What is the current standard practice for collection tube order for CSF testing? Read answer. Q. What is the significance of the absence of coagulation of seminal fluid in a patient who previously experienced normal seminal fluid coagulation, followed by normal liquefaction, and had fathered children? Are there medications that can prevent seminal fluid coagulation? Read answer.

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Newsbytes

Digital pathology: from education to implementation July 2019—Matthew Hanna, MD, is well aware that not all pathologists embrace the idea of using digital pathology for clinical applications. “I’m very confident it’s a familiarity issue,” says Dr. Hanna, clinical instructor in breast pathology and informatics at Memorial Sloan Kettering Cancer Center.

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Anatomic pathology selected abstracts

July 2019—Although the majority of low-grade, early stage endometrial cancer patients have good survival rates with surgery alone, patients who recur tend to do poorly. Identifying patients at high risk of recurrence who would benefit from adjuvant treatment or more extensive surgical staging would improve individualized care for endometrial cancer patients.

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Molecular pathology selected abstracts

July 2018—The use of liquid biopsies to non-invasively detect and monitor cancer is rapidly expanding. In these assays, fragments of cell-free DNA (cfDNA), which are released when cells undergo necrosis or apoptosis, are isolated from the patient’s plasma and sequenced. Because cfDNA can originate from cancer cells and normal cells, the variant allele frequency of cancer-specific somatic mutations can often be very low.

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Letters, 11/14

November 2014—We read with great interest the two recent articles by William Check, PhD, highlighting primary HPV testing proposals (June and September 2014). Additional related information not covered in the two CAP TODAY articles should be brought to readers’ attention.

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Minimum set of alleles recommended for clinical CYP2C9 genotyping
June 2019—A joint report from the CAP and the Association for Molecular Pathology was published last month to aid in the design and validation of clinical CYP2C9 assays, promote standardization of testing across different laboratories, and improve patient care. The report, “Recommendations for Clinical CYP2C9 Genotyping Allele Selection: A Joint Recommendation of the Association for Molecular Pathology and College of American Pathologists,” was released online ahead of publication in the Journal of Molecular Diagnostics. The AMP Pharmacogenetics Working Group is developing a series of guidelines to help standardize clinical testing for frequently used genotyping assays. Developed with organizational representation from the CAP and the Clinical Pharmacogenetics Implementation Consortium, the latest report follows a set of recommendations for clinical CYP2C19 genotyping allele selection published in May 2018.

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Newsbytes

June 2019—How Orchard Software is helping labs address transgender care: Establishing useful reference ranges for cisgender patients can be difficult, and for transgender patients it can be even more challenging. Add to this the desire to show the reference ranges for transgender patients as separate categories, distinct from the values for male and female patients, and the challenges mount for some medical centers. Read more.

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From the President’s Desk: Best-kept secret in medicine

June 2019—I wasn’t one of those kids who always knew they wanted to be a doctor. Science was a powerful draw, which might have suggested medical school if my sister hadn’t gotten there first. But she did, so I majored in chemistry at Vanderbilt. As an undergraduate with little money, I hoped to fast-track, so I found a summer job anesthetizing laboratory rats in the middle of the night and removing their kidneys. The work supported a group studying the renin-angiotensin system. They thought I had a knack for surgery, which prompted a reassessment of my chemistry major and eventually led to an application to medical school. Life makes choices for us sometimes, and I was lucky that way.

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Clinical pathology selected abstracts

June 2019—Dietary patterns during adulthood and cognitive performance in midlife. Cognitive impairment is associated with an increased risk of mortality, disability, and late-life dementia, which contributes to the rising costs of health care. Several studies have demonstrated cognitive decline in midlife, and some data have linked this decline to cardiovascular disease risk factors or a more sedentary lifestyle. Diet is a modifiable exposure, but few studies have analyzed the risk of cognitive impairment due to dietary factors.

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Anatomic pathology selected abstracts

June 2019—Markers for differentiating triple-negative breast cancer from TTF1-negative
lung adenocarcinoma. Triple-negative breast cancer patients have an increased risk of developing visceral metastases and other primary nonbreast cancers, particularly lung cancer. The differential diagnosis of triple-negative breast cancer (TNBC) metastases and primary cancers from other organs can be difficult due to lack of a TNBC standard immunoprofile.

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Molecular pathology selected abstracts

June 2019—Link between immunogenic neoantigens derived from gene fusions and T-cell responses. Immunotherapy is quickly emerging as an important therapeutic strategy for hematologic and solid tumors. In 
principle, immune cells recognize unique non-self antigens expressed by cancer cells and this serves as the initial step in eliminating such cells. Among the metrics used to assess the likelihood of response to immunotherapy is the presence of a high level of somatic mutations, referred to as tumor mutation burden (TMB). This serves as a surrogate for extrapolating the level of neoantigens ex-
pressed by cancer cells.

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Early Sepsis Indicator receives 510(k) clearance
May 2019—Beckman Coulter’s Early Sepsis Indicator received 510(k) clearance from the Food and Drug Administration. Beckman Coulter says clinical trial findings showed that its monocyte distribution width biomarker best discriminated sepsis from all other conditions when combined with the current standard of care. The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with differential for adult emergency department patients. A positive Early Sepsis Indicator result signals a higher probability of sepsis. Compared with reviewing WBC count alone, Beckman Coulter says the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43 percent and, together with clinical signs and symptoms, improves confidence in helping to rule out sepsis by 63 percent. The indicator can be used in conjunction with the company’s Multidiscipline Reflex Rules in Remisol Advance middleware.

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Newsbytes

May 2019—Excel tool color codes persistent  problems in lab test ordering: Variety may be the spice of life, but in the pathology lab, it may present a conundrum. Case in point: The LIS is a rich source of data about lab test utilization, but managing millions of disparate pieces of data to assess test utilization can be difficult. But not to Tylis Y. Chang, MD, of Northwell Health.

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From the President’s Desk—CAP Center: If we couldn’t do it, who could?

May 2019—The CAP Center for Pathology and Laboratory Quality for Evidence-Based Guidelines has partnered or collaborated with more than 20 societies to produce 15 published laboratory practice guidelines—with 10 more underway. The Center is one of the best things we do and one of the things we do best.One thing about the CAP: We make no small plans. It was that way when we decided to inspect and then accredit laboratories. It was that way when we decided to hold an independent annual meeting. And it was that way when the CAP Center had its first official guidelines published in Archives of Pathology & Laboratory Medicine.

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Clinical pathology selected abstracts

May 2019—Optimization of laboratory ordering practices for CBC with differential: Over 5 billion laboratory tests are performed in the United States each year, and more than 20 percent are considered unnecessary. The American Board of Internal Medicine Foundation initiated the Choosing Wisely campaign in 2012 to increase awareness of wasteful or unnecessary medical tests, procedures, and treatments. Studies have shown that tests ordered without a clear rationale not only waste resources but are also a source of iatrogenic anemia, which has been associated with increased blood transfusions, lengths of stay, and mortality.

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Anatomic pathology selected abstracts

May 2019—ALK-rearranged tumors in the STUMP subcategory of uterine tumors: Smooth muscle tumor of uncertain malignant potential is a rare diagnosis rendered when there is uncertainty concerning the biological potential of a smooth muscle tumor. The initial differential diagnosis is often broad, as tumors in this subgroup are morphologically heterogeneous. Recent data suggest that uterine inflammatory myofibroblastic tumors (IMTs) with anaplastic lymphoma kinase (ALK) rearrangement may be misclassified as smooth muscle tumor of uncertain malignant potential (STUMP), but the extent to which this occurs has not been examined.

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Molecular pathology selected abstracts

May 2019—Diagnosing and targeting pancreatic cancer at the single-cell level: Pancreatic ductal adenocarcinoma is a highly aggressive cancer that is often unresectable at the time of diagnosis. It also is frequently metastatic and associated with a high mortality rate. One approach to reduce the poor outcomes associated with this disease could involve early detection and treatment of the cancer before it develops the ability to invade and spread to other organs.

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Shield launches test 
for antibiotic susceptibility 
in N. gonorrhoeae April 2019—Shield Diagnostics launched Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae. “Rapid molecular testing for ciprofloxacin resistance allows for smarter medicine,” Jeffrey D. Klausner, MD, MPH, a professor of infectious disease medicine at the University of California, Los Angeles, said in a Shield statement. “Right now we’re treating gonorrhea with a sledgehammer; we’re treating everything with the same exact regimen. And it’s not a surprise that the organism will become resistant to what we’re currently using.” Ciprofloxacin can be used to treat 80 percent of infections and is 99.8 percent effective when susceptibility has been determined. Because it is administered as a single oral dose, rather than the current injectable treatment, clinicians can prescribe antibiotics for the patient to give to their partners. “Shield has launched Target-NG to help clinicians adopt a precision medicine approach to gonorrhea treatment,” said Nidhi Gupta, PhD, lead scientist on the project.

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Newsbytes

April 2019—The R&B classic “Time Is on My Side” may be an anthem for rejected lovers, but a new virtual reality teaching tool that allows students to “visit” the pathology lab without leaving the classroom may soon have NYU medical students humming the song’s refrain.

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From the President’s Desk: CAP Learning: building on feedback

April 2019—As Dr. Seuss famously wrote, “It is fun to have fun, but you have to know how.” CAP Council on Education chair Jennifer Hunt, MD, MEd, agrees. Learning styles evolve as we mature, she says; grownups are not just tall children. We know what we want to do and are drawn to knowledge we can use. Most pathologists are born educators; we can’t help ourselves. We like to think about how we learn. I think that’s why the CAP Learning team does such an outstanding job—they know what to ask, how to listen, and when to act. Participant evaluations are scrutinized and what we learn from them is applied quickly.

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Clinical pathology selected abstracts

April 2019—Trauma resuscitation considerations: gender as a biological variable: Sex dimorphisms in coagulation are well established, with females manifesting a more hypercoagulable profile, but the relationship between sex dimorphism in coagulation and trauma outcomes has not been investigated. Trauma-induced hemorrhage remains a leading cause of early post-injury death.

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Anatomic pathology selected abstracts

April 2019—Frequent GNAQ and GNA14 mutations in hepatic small vessel neoplasm: April 2019—Hepatic small vessel neoplasm is a recently described infiltrative vascular neoplasm of the liver composed of small vessels. Although its infiltrative nature can mimic angiosarcoma, hepatic small vessel neoplasms (HSVNs) are thought to be benign or low-grade neoplasms because they lack cytologic atypia and increased proliferation.

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Molecular pathology selected abstracts

April 2019—Variants in NUDT15: association with thiopurine–induced myelosuppression: The thiopurines mercaptopurine, thioguanine, and azathioprine are purine antimetabolites widely used as anticancer and immunosuppressive agents. Commonly prescribed in patients with inflammatory bowel diseases (IBD), such as Crohn’s disease and ulcerative colitis, they are valuable steroid-sparing treatment options.

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Lumipulse G β-Amyloid Ratio test has breakthrough device designation
March 2019—Fujirebio Diagnostics received on Feb. 1 breakthrough device designation from the FDA Center for Devices and Radiological Health for its Lumipulse G β-Amyloid Ratio (1-42/1-40) quantitative in vitro diagnostic test. The test uses measurable β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid and combines those concentrations into a numerical ratio of β-amyloid 1-42/β-amyloid 1-40 to estimate the presence of β-amyloid neuritic plaque pathology in the brain. The Lumipulse G β-Amyloid Ratio (1-42/1-40) combines the results of Lumipulse G β-amyloid 1-42 and β-amyloid 1-40 using the Lumipulse G System. The ratio results are intended to aid in assessing adult patients, ages 50 and over, who present with cognitive impairment and are being evaluated for Alzheimer’s disease and other causes of cognitive decline. The results must be interpreted in conjunction with other diagnostic tools such as neurological examination.

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Newsbytes

Building a lab or modernizing? Don’t forget the following March 2019—Building a new pathology lab or revamping an existing one gives laboratory decision-makers an opportunity to rethink information technology infrastructure and address persistent problems, plan for new technology, and improve processes.

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From the President’s Desk: Our study of member services and support

March 2019—We launched the CAP member services and support strategy two years ago, setting out to figure out which benefits were most valued by the greatest number of members, identify places where we could find better ways to direct or maintain them, and see where we could be falling short. To keep everyone connected and everything on track, we created a coordinating group whose members had access to a fine staff and thoughtfully curated findings from years of member surveys and market research. Our own surveys showed how the interests and needs of our members overlapped. The market provided context.

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Anatomic pathology selected abstracts

March 2019—ALK expression in angiomatoid fibrous histiocytoma: a potential diagnostic pitfall: The authors recently encountered a case of primary pulmonary angiomatoid fibrous histiocytoma (AFH), which was initially misdiagnosed as inflammatory myofibroblastic tumor based in part on anaplastic lymphoma kinase expression by IHC. Prompted by this experience, they evaluated anaplastic lymphoma kinase (ALK) expression in 11 AFH, 15 inflammatory myofibroblastic tumors (IMT), and 11 follicular dendritic cell sarcomas using three antibody clones: D5F3, 5A4, and ALK1.

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Molecular pathology selected abstracts

March 2019—Using circulating cell-free fetal DNA to test for monogenic disorders: Screening for fetal chromosomal abnormalities can be performed by noninvasive methods in which fetal cell-free DNA (cfDNA) circulating in the maternal blood is isolated and analyzed. However, the standard of care for screening for monogenic diseases remains population-based carrier screening—testing the parents for their carrier status of deleterious genes.

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Hologic assay is first FDA-cleared test to detect M. genitalium
February 2019—The Food and Drug Administration granted clearance for Hologic’s Aptima Mycoplasma genitalium assay. This is the first test the FDA has authorized for M. genitalium detection. The FDA reviewed data from a clinical study that included testing of 11,774 samples. The FDA says the study showed that the Aptima assay correctly identified M. genitalium in approximately 90 percent of vaginal, male urethral, male urine, and penile samples. It correctly identified M. genitalium in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively. Vaginal swabs are the preferred sample type owing to better clinical performance. Alternative sample types, such as urine, can be used if vaginal swabs are not available. In addition, the study showed that the test correctly identified samples that did not have M. genitalium present 97.8 to 99.6 percent of the time. The FDA reviewed the Aptima M. genitalium assay through the de novo premarket pathway.

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Q&A column

Q. When performing a manual differential that contains immature cells, such as metamyelocytes and myelocytes, do you report an absolute count on all of the individual cells in the myelocytic line, or do you group them together and calculate one ANC? What about lymphocytes and reactive lymphocytes? Read answer. Q. Why and in what employment screening settings is the two-step skin test for Mycobacterium tuberculosis recommended? Read answer.

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From the President’s Desk: Giving group practices what they need most

February 2019—In last month’s column, we talked about practice engagement as an umbrella term for laboratory medical direction and practice management that builds strong relationships within and beyond the laboratory. The CAP Practice Management Committee has been taking the lead on this, but it cuts across multiple domains; the conundrum, as always, is the complexity of what we do. Practice management tools designed for other settings cannot meet our needs because we must address economy, efficiency, effectiveness, and collegiality concerns specific to pathology. But then, affinity for complexity is how we landed here in the first place, so that plays to our strengths.

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Anatomic pathology selected abstracts

February 2019—Diagnostic algorithmic proposal based on IHC evaluation of invasive endocervical adenocarcinomas: The International Endocervical Adenocarcinoma Criteria and Classification was developed to separate endocervical adenocarcinomas into two main categories based on morphology: human papilloma virus-associated (HPVA) and nonhuman papilloma virus-associated adenocarcinomas.

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Newsbytes

February 2019—Digital pathology RFPs: from the questions to selections: To those who request the information and those who supply the information, requests for proposal, better known as RFPs, can be groanworthy. Yet laboratories planning to purchase a digital pathology system for clinical use should seriously consider going through the painstaking process, even if their institutions don’t require it, says Liron Pantanowitz, MD, vice chair of pathology informatics at the University of Pittsburgh Medical Center.

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FDA clears 2 of 3 ePlex blood culture ID panels:
January 2019—GenMark Diagnostics announced in December that it received FDA market clearance for its ePlex Blood Culture Identification Gram-Positive (BCID-GP) and Fungal Pathogen (BCID-FP) panels. GenMark’s third panel, ePlex Blood Culture Identification Gram-Negative (BCID-GN), was submitted to the FDA in September 2018 and is still under review. The fungal pathogens panel has broad coverage and includes many resistant and emerging strains, among them Candida auris, GenMark said in its statement. The company says that by coupling BCID panels with the ePlex Templated Comments software module, hospitals can enable immediate intervention linked to a diagnostic result and improve the effectiveness of antimicrobial stewardship initiatives.

12 assays for Atellica Solution:
Siemens Healthineers achieved 12 pre-market approvals from the FDA for its Atellica Solution infectious disease and oncology testing menu.

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Newsbytes

January 2019—Virtual tumor board platforms: a game changer for cancer case review: If Suneal Jannapurredy, MD, had been able to read the patient’s outside radiology report prior to breast tumor board, he would have re-examined the gross specimen to determine whether, as the other providers were now telling him, there was a second area of focus he hadn’t included in his presentation.

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Anatomic pathology selected abstracts

January 2019—Distinguishing patients with double somatic mismatch-repair mutations from those with Lynch syndrome: Lynch syndrome is the most common form of hereditary colon cancer. Germline mutations in the mismatch-repair (MMR) genes MLH1, MSH2 (EPCAM), MSH6, and PMS2, followed by a second hit to the remaining allele, lead to cancer development.

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Molecular pathology selected abstracts

Editors: Donna E. Hansel, MD, PhD, chief, Division of Anatomic Pathology, and professor, Department of Pathology, University of California, San Diego; James Solomon, MD, PhD, resident, Department of Pathology, UCSD; Richard Wong, MD, PhD, molecular pathology fellow, Department of Pathology, UCSD; and Sounak Gupta, MBBS, PhD, molecular pathology fellow, Memorial Sloan Kettering Cancer Center, New York. Development of brain circuits ...

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Pathologists and population health—
first steps

December 2018—Pathologists and population health—first steps: Pathologists who want to become involved in population health initiatives can take five main steps, say pathologists and laboratory leaders interviewed for an article published online last month in Archives of Pathology & Laboratory Medicine. In “The role of the pathologist in population health,” the authors report on the interviews they conducted and their review of the literature to answer several questions, among them whether pathologists in both large settings and smaller community-based settings can engage in population health (yes), and whether pathologists are in a position to analyze data for population health (“The data are there,” they say, “but getting to the data—and providing meaning out of it—is the hard part”). One of the first steps to becoming involved in any type of population health management activities, the authors write, is to understand the philosophy of the institution’s CEO and senior management.

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Q&A column

Q. Can you explain further the revised CAP checklist requirement COM.40850 “LDT and Class I ASR Reporting,” which says to describe the method and performance characteristics in test reports unless the information is available to the clinician in an equivalent format? Read answer. Q. Can we see reactive lymphocytes in the pediatric population (under age two), and can we report them? Read answer.

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Newsbytes

In molecular testing labs, gaps between actual and desirable LIS capabilities
December 2018—Flashback to 2013: Alexis B. Carter, MD, then director of pathology informatics at Emory University Hospital, was contemplating whether other pathology labs nationwide were facing the same challenges managing molecular testing data as she and her colleagues. So she decided to find out. Dr. Carter conducted a survey, and the responses confirmed her suspicions: Most laboratory information systems fall short in providing the infrastructure for complex molecular and genomic testing.

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Clinical pathology selected abstracts

Prostate cancer screening with PSA test: systematic review and meta-analysis

December 2018—Prostate cancer is the second most common cancer and the fifth leading cause of cancer-associated mortality among men worldwide. The use of serum prostate-specific antigen (PSA) to screen for prostate cancer is intended to detect the cancer at an early stage to reduce overall and disease-specific mortality. However, evidence that PSA screening for prostate cancer saves lives is somewhat lacking.

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Anatomic pathology selected abstracts

December 2018—Applying deep convolutional neural networks to diagnostic breast biopsies: The breast stromal microenvironment is a pivotal factor in breast cancer development, growth, and metastases. Although pathologists often detect morphologic changes in stroma by light microscopy, visual classification of such changes is subjective and nonquantitative, limiting its diagnostic utility.

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Molecular pathology selected abstracts

December 2018—Profiling of chromatin-accessibility landscape of primary cancers: The chromatin-accessibility profiles generated in this study by The Cancer Genome Atlas represent the largest pan-cancer effort to characterize the regulatory landscape of human cancers. The study primarily used an assay for transposase-accessible chromatin using sequencing (ATAC-seq).

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Quest acquires PhenoPath
November 2018—Quest Diagnostics has acquired PhenoPath Laboratories, which provides immunophenotyping, hematopathology, and molecular pathology services. The PhenoPath business, in Seattle, will operate as part of AmeriPath, a wholly owned business of Quest. Steve Rusckowski, Quest chairman, president, and CEO, said in a statement: “PhenoPath has a strong record of innovation and provides several capabilities that complement and extend our own, particularly in pathology and molecular oncology. It also deepens our presence in the Pacific Northwest.” PhenoPath founder Allen Gown, MD, tells CAP TODAY that continued consolidation in the laboratory industry and insurance reimbursement challenges have posed significant risks to PhenoPath’s future growth. “In Quest/AmeriPath,” he says, “we found an organization that realized not only the excellence of PhenoPath’s past and present but also the extraordinary future that, with their assistance, we can have.” Dr. Gown founded PhenoPath in 1998.

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Newsbytes

How Henry Ford core lab uses bottom-up communication November 2018—When Henry Ford Health System started planning its core laboratory’s automation line four years ago, aware that it needed to take Lean to the next level, it enlisted frontline laboratory employees in a development process that used the strategies of Hoshin Kanri and kaizen. Read more.

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Clinical pathology selected abstracts

Preparing for passage of regulatory requirements for laboratory-developed tests: November 2018—The FDA has raised concerns, in recent years, about several high-risk laboratory-developed tests (LDTs), including a concern that patients may undergo unnecessary treatment or delay or forego treatment due to the inaccuracy of such tests. Other agencies have also challenged the validity, accuracy, oversight, and safety of LDTs, a subset of IVDs that are intended for clinical use and designed, manufactured, and used within a single laboratory.

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Anatomic pathology selected abstracts

November 2018—HER2: a pan-cancer event highly enriched in AR-driven breast tumors: Approximately one in five breast cancers is driven by amplification and overexpression of the HER2 receptor kinase, and HER2 enriched is one of four major transcriptional subtypes of breast cancer. The authors conducted a study to understand the genomics of HER2 amplification independent of subtype, as well as the underlying drivers and biology of HER2-enriched (HER2E) tumors.

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Molecular pathology selected abstracts

November 2018—Common genetic variants contribute to risk of rare severe neurodevelopmental disorders: The traditional paradigm broadly classifies genetic diseases into rare disorders caused by a single gene variant and common disorders caused by complex interplay among multiple genes. However, recent research has shown that penetrance and disease phenotype, even in disorders thought to be monogenic, are affected by common genetic variation.

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Letters: Ph-like ALL

November 2018—In the October issue of CAP TODAY, Karen Titus shared with us a story titled, “Fresh incentive to look for Ph-like ALL.” She spoke with key players in the discovery of BCR-ABL1-like B-lymphoblastic leukemia/lymphoma (B-ALL) (or “Ph-like” ALL), which is now a provisional entity in the 2016 revised fourth edition of the WHO. A key takeaway from the article ...

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Therascreen EGFR RGQ PCR kit approved as companion diagnostic for Vizimpro October 2018—The FDA has approved a PMA supplement expanding the labeling claim of the Qiagen Therascreen EGFR RGQ PCR kit to allow its use as a companion diagnostic with Pfizer’s Vizimpro (dacomitinib). Vizimpro is for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or an exon 21 L858R mutation. The Therascreen EGFR RGQ PCR kit is now approved as a companion diagnostic to guide the use of three FDA-approved therapies, including also Gilotrif (afatinib) from Boehringer Ingelheim and Iressa (gefitinib) from AstraZeneca. It is registered in more than 40 countries. This was a project governed under an agreement between Qiagen and Pfizer.

Philips introduces computational pathology software for tumor detection Royal Philips announced in September the latest release of TissueMark, which the company says now supports region of interest detection for the majority of molecular testing.

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From the President’s Desk—CAP accreditation: perspective-taking 101

October 2018—I grew up in the CAP as a volunteer in the Laboratory Accreditation Program. It’s a good place to dive in. Many of us do what I did—work our way through many volunteer opportunities over 30 years or more because each was so interesting. There are an amazing number of ways a person can approach challenges in a laboratory; more amazing is how many of the approaches will work. Partly that’s because the learning cuts both ways—I’ve learned as much when we were inspecting another laboratory as when my laboratory was being inspected.

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Clinical pathology selected abstracts

RT-PCR detection of B. microti parasites using BMN antigens as amplification targets October 2018—Babesia microti infection, which is transmitted through the bite of an infected tick, is a growing health concern and continues to be a threat to the blood supply, with 22 states having reported cases of babesiosis in 2014. While most healthy adults with Babesia infection are asymptomatic or present with mild symptoms, including fever, fatigue, and anemia, babesiosis can be severe or fatal in neonates, the elderly, and immunosuppressed individuals.

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Anatomic pathology selected abstracts

Analysis of ZC3H7B-BCOR high-grade endometrial stromal sarcomas October 2018—High-grade endometrial stromal sarcoma likely encompasses underrecognized tumors harboring genetic abnormalities besides YWHAE–NUTM2 fusion. Triggered by three initial endometrial stromal sarcomas with ZC3H7B–BCOR fusion characterized by high-grade morphology and aggressive clinical behavior, the authors investigated the clinicopathologic features of this genetic subset by expanding the analysis to 17 such tumors. All of the tumors occurred in women who were a median age of 54 (range, 28–71) years.

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Molecular pathology selected abstracts

Cell-free DNA tumor mutational burden predicts efficacy of immune checkpoint inhibitors October 2018—Immune checkpoint inhibitors have emerged as a potent class of therapy for a variety of malignancies. The biologic rationale for these drugs is that somatic mutations, not necessarily in cancer driver genes, may accumulate in tumor cells, resulting in amino acid changes that create neoantigens (epitopes not present in normal cells during maturation of the immune system).

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Letters

AMH immunoassays October 2018—In the article “Satisfaction high with new automated AMH assays” (June 2018), the focus seems to be on the presumed advantages of the Roche Elecsys and Beckman Coulter Access automated anti-müllerian hormone assays over manual AMH assays. The article reports that the main advantages of the automated platforms are less variability in AMH measurements, greater assay turnaround time, and greater assay cost-effectiveness.

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Broad-based molecular testing for NSCLC September 2018—A recently published study on broad-based genomic sequencing and survival among patients with advanced non-small cell lung cancer in the community oncology setting should not lead to the conclusion that such sequencing should be avoided in nonsquamous NSCLC, say Paul A. Bunn Jr., MD, and Dara L. Aisner, MD, PhD, of the University of Colorado Denver, Aurora. Dr. Bunn, of the Department of Medical Oncology, and Dr. Aisner, of the Department of Pathology, in an editorial published Aug. 7 in JAMA, caution readers about the study published in the same issue, which found that broad-based sequencing (more than 30 cancer genes) directly informed treatment in a minority of patients and was not independently associated with better survival. The study of 5,688 patients with advanced NSCLC was based on data acquired through abstraction and aggregation of information from the electronic medical record from 191 U.S. community oncology practices.

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Q&A column

Q. Is there expert advice or standard practice for releasing preliminary critical values for patients to the LIS pending subsequent technologist or technician verification and documentation? Read answer. Q. We hope to validate a procedure for the fixation, decalcification, and staining of bone marrow specimens but we will not be able to access fresh marrow specimens for our decalcification validation. Can you recommend an alternative tissue to validate the preservation of tissue morphology and antigenicity after decalcification? Read answer.

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Clinical pathology selected abstracts

Outcomes of an audit of repeat lab testing at an academic medical center
September 2018—Overutilization of laboratory tests increases health care costs and may lead to false-positive test results and ambiguous findings. Unnecessary testing can result from a single order from a provider, an automated function in an order set, or a combination of the two.

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Anatomic pathology selected abstracts

Thymoma: a clinicopathological correlation of surgical resection cases
September 2018—The authors presented 1,470 surgical resections for thymoma from the pathology files of 14 institutions in 11 countries with the purpose of determining and correlating a simplified histological classification of thymoma and pathological staging with clinical outcome.

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Molecular pathology selected abstracts

Ability of genetic alterations to predict development of acute myeloid leukemia
September 2018—Acute myeloid leukemia affects more than 60,000 people in the United States every year and has a mortality rate of more than 90 percent. It is the most common form of acute leukemia and is caused by unchecked growth of immature precursor cells in the bone marrow. These immature cells, or blasts, are myeloid precursors that often develop into dysfunctional, cancerous white blood cells that fill the bone marrow and spread into the blood.

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Newsbytes

Nebraska informaticians mine and translate genomic data
September 2018—More than five years have elapsed since clinicians at the University of Nebraska Medical Center approached the institution’s informatics department with a problem. They wanted to more easily access structured genomic data stored in the EHR system for the diagnosis of cancer patients.

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Cobas HPV test approved for first-line screening using SurePath preservative fluid
August 2018—Roche received FDA approval for the Cobas HPV test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid. The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It is approved for all of the screening indications supported by guidelines—primary screening in women 25 and older, reflex testing of unclear Pap test results in women 21 and older, and cotesting with a Pap test in women 30 and older—with both of the primary collection media types. “With this additional approval for the Cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types,” Ann Costello, head of Roche tissue diagnostics, said in a statement.

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Clinical Pathology Abstracts

Association of perioperative RBC transfusions with venous thromboembolism
August 2018—Hospital-associated venous thromboembolism is a major cause of morbidity and mortality, resulting in 100,000 to 200,000 deaths annually. Surgery can lead to a proinflammatory state and be a prothrombotic stimulus for venous thromboembolism (VTE). General anesthesia, as well as red blood cells transfused in the perioperative setting, is considered an independent risk factor for VTE.

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Anatomic Pathology Abstracts

Analysis of the surveillance of women diagnosed with atypical ductal hyperplasia on core needle biopsy
August 2018—A needle core biopsy diagnosis of atypical ductal hyperplasia is an indication for open biopsy. The launch of randomized clinical trials of active surveillance for low-risk ductal carcinoma in situ leads to the paradoxical situation of women with low-grade ductal carcinoma in situ being observed and those with atypical ductal hyperplasia having surgery.

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Molecular Pathology Abstracts

Prevalence of clonal hematopoiesis mutations in tumor-only clinical genomic profiling of solid tumors
August 2018—Challenges to implementing next-generation sequencing-based comprehensive molecular profiling of solid tumors include reliably separating germline variants from somatic variants. This is an important consideration, particularly when a “tumor-only” profiling approach is used.

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Newsbytes

New digital pathology certificate program educates ‘from A to Z’
August 2018—While there’s a lot of buzz about the growth of digital pathology, its steep learning curve is a potential impediment to implementation. Recognizing this, the National Society for Histotechnology, in collaboration with the Digital Pathology Association, launched in May a web-based digital pathology certificate program designed to provide both a broad overview of digital pathology and a deep dive into the details.

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High-sensitivity troponin I assay available in the U.S.
July 2018—Beckman Coulter Diagnostics received 510(k) clearance from the Food and Drug Administration for its new high-sensitivity troponin assay, Access hsTnI, for use on the Access 2, DxI, and the entire Access family of immunoassay systems. Access hsTnI demonstrates less than 10 percent CV at the upper reference limits for men and women and detects troponin in more than 50 percent of the healthy population. In an independent study, Access hsTnI detected more than 99 percent of troponin values for healthy men and women (Pretorius CJ, et al. Clin Biochem. 2018;​55:​49–55). “Beckman Coulter’s high-sensitivity cardiac troponin I assay can measure very low cardiac troponin concentrations with excellent precision. This test may help physicians with both the early diagnosis of myocardial infarction and future risk stratification in and outside the acute coronary syndrome setting,” Peter Kavsak, PhD, associate professor, Department of Pathology and Molecular Medicine, McMaster Uni­versity, said in a statement.

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Clinical Pathology Abstracts

Trends in perioperative RBC transfusion from index cases in five surgical specialties
July 2018—In recent years, greater attention has been given to patient blood management. While contemporary national guidelines recommend restrictive red blood cell transfusion, it is not known whether such transfusions have decreased in surgical patients. Approximately 11 million RBC transfusions are performed annually, and two-thirds of those are for patients in the perioperative period.

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Q&A column

July 2018—Is CD30 currently being used as a predictive marker for therapy? Due to laboratory construction, our molecular instruments were relocated within the lab. Is full test validation required in this case? Or is running at least 20 known samples enough to verify the instrument/assay performance specifications?

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Newsbytes

July 2018—How a geospacial tracking system is closing the distance at Michigan lab: This summer, when the Michigan Medicine Department of Pathology moves the last of its laboratories to a new campus four-and-a-half miles from the existing University Hospital laboratories in Ann Arbor, it will kick its new PathTrack Lean-influenced real-time geospatial tracking system into high gear. Developing the system, which will monitor an anticipated 6,000 to 10,000 specimens every day, has been “a monumental effort,” says Ulysses J. Balis, MD, director of the health system’s division of pathology informatics.

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Anatomic pathology Abstracts

Clinical and molecular analyses of neuroendocrine carcinomas of breast
July 2018—Clinical and molecular analyses of neuroendocrine carcinomas of breast: Neuroendocrine breast carcinomas represent a rare subtype of breast cancer. Their definition, prevalence, and prognosis remain controversial, as reported in the literature.

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Molecular pathology selected abstracts

July 2018—Correlation between tumor mutation burden and efficacy of combination immunotherapy in nonsmall cell lung cancer: Checkpoint inhibitor therapy has dramatically improved outcomes in many cancer types, with treatments including antibodies against cytotoxic T-lymphocyte–associated protein 4 (CTLA-4), programmed cell death receptor-1 (PD-1), and its ligand (PD-L1).

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Letters

July 2018—I was excited to see the article “Clearing the air for electronic cancer checklists” (May 2018) and would like to share what we at Sunquest are doing to contribute to adoption of the electronic cancer checklists. Sunquest is continually improving the PowerPath Synoptics tool set, which is included as part of our base system.

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Q&A column

June 2018—What is the role of total testosterone and free testosterone in gauging the effectiveness of androgen deprivation therapy?

We are planning to validate the mismatch repair panel in our immunohistochemistry laboratory. Do we use the CAP guidelines for antibody validation for a nonpredictive marker or a predictive marker?

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Newsbytes

June 2018—Electronic device shows promise for identifying pathology specimens: While barcodes and radio-frequency identification are considered the workhorses of pathology specimen identification, a new technology, nearly two decades in the making, may soon get a piece of the action.

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June 2018—FDA clears T2Bacteria panel for detecting sepsis-causing pathogens: T2 Biosystems received market clearance from the Food and Drug Administration for the T2Bacteria panel for the direct detection of bacterial species in human whole blood specimens from patients with suspected bloodstream infections.

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Letters

June 2018—LCIS variants and DCIS: We write in response to the article by Karen Lusky regarding tips to distinguish DCIS from variant forms of LCIS (April 2018). A different question might be: Is it actually important to distinguish these two in situ proliferations?

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