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ARTICLES

Chronological index 2013–2018

Cytopathology in focus: Lab performance in 2018—a year-end tally

August 2019—The CAP has a long-standing commitment to education in cytopathology, with a number of organized educational offerings in gynecologic and nongynecologic cytopathology. The Interlaboratory Comparison Program in nongynecologic cytopathology (NGC Education) was started in 1997 and the Interlaboratory Comparison Program in fine-needle aspiration glass slide education (FNAG) in 2010. These programs are strictly educational and not graded or used for proficiency testing. Semiannual (FNAG) and quarterly (NGC) mailings include four or five cases. For each case, glass slides generally stained with a Diff-Quik and/or Pap stain are provided.

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Cytopathology in focus: BD Onclarity HPV assay now in CAP HPV Surveys

August 2019—The BD Onclarity HPV assay is a human papillomavirus test approved by the Food and Drug Administration on Feb. 12, 2018. The assay is a qualitative test for detection of HPV in cervical specimens collected either with a broom or endocervical brush/spatula combination and placed in a BD SurePath liquid-based cytology vial. The assay is not approved for use with ThinPrep collection media (PreservCyt).

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TDM to the rescue in biologics boom

July 2019—In the early, heady days of biologic therapies, use of these drugs resembled a common military tactic of the Civil War: charge and retreat, charge and retreat, charge and retreat. The approach, though modern at the time, often proved disastrous. Jeffry Katz, MD, recalls the excitement that greeted the arrival of anti-tumor necrosis factor-α agents, starting with infliximab (Remicade) in 1998. “What we used to do is we would give patients a drug, and we would wait for them to get sicker,” says Dr. Katz, medical director, inflammatory bowel diseases, University Hospitals Cleveland Medical Center, and professor of medicine, Case Western Reserve University School of Medicine.

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A killer app comes out of the crowd

July 2019—Twenty years ago, Ulysses Balis, MD, bought the domain name Histo­Query.org. He had realized that one day, digital pathology would be sophisticated enough to be incorporated into interactive, Web-based tools, so he did what any self-styled geek would do with such a nascent idea—he waited.

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Letters

July 2019—We thoroughly enjoyed the article by Anne Paxton, “Microscopy’s dangers: From wear and tear to disabling injury” (April 2019). This is an underrepresented topic in the pathology world. I have been practicing for nearly 11 years; we are a group of 13 pathologists including part-time and full-time pathologists. Two female senior pathologists in our group underwent neck surgery less than a year apart owing to years of accumulated trauma.

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In memoriam

July 2019—Elizabeth R. Cary, MD, state commissioner for Mississippi for the CAP Laboratory Accreditation Program, died on May 31 at age 81.Dr. Cary was the chief of clinical pathology at the G.V. (Sonny) Montgomery VA Medical Center in Jackson, Miss. In 1994, the CAP appointed Dr. Cary as Mississippi state commissioner. The following year, the VA appointed her as regional commissioner for the national VA system.

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Hemostasis testing: What is the impact of direct oral anticoagulants?

July 2019—Prevention and treatment of venous thromboembolic disease is accomplished through the use of anticoagulant agents, which are prescribed for ­millions of Americans annually. A revolution in anticoagulant use has occurred over the last decade, as direct oral anticoagulants (DOACs) were introduced to the market. The new agents have a number of advantages over warfarin, the traditionally administered oral agent, which is a vitamin K antagonist (VKA).

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From CAP Press: In new book, a practical approach to renal biopsy

July 2019—New from CAP Press is Medical Kidney Diseases—Morphology-Based Novel Approach to Renal Biopsy, by Huma Fatima, MD, assistant professor and director of the renal pathology laboratory, Department of Pathology, University of Alabama at Birmingham. It presents a simple and practical approach to renal biopsy by providing a pertinent differential diagnosis related to various patterns of injury involving renal parenchyma by light microscopy and reaching a correct diagnosis by assimilating immunofluorescence and electron microscopy findings. The 90-page book contains 66 cases, two of which we are reprinting here.

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Puzzles, pearls: diagnosing interstitial lung disease

July 2019—Most fresh blood in lung wedge biopsies is artifact, but when it’s diffuse alveolar hemorrhage, the pathologist must call the clinician because DAH patients can go downhill fast. Maxwell L. Smith, MD, a consultant in the Department of Laboratory Medicine and Pathology at Mayo Clinic Arizona and associate professor, Mayo Clinic School of Medicine, shared that pearl from one of the 10 consultation cases he and Brandon T. Larsen, MD, PhD, co-presented in their CAP18 session on diagnosing interstitial lung disease. Their discussion of two of those cases follows.

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Chemistry and immunoassay testing: Standardizing platforms, ranges, interfaces—panel weighs in

July 2019—One vendor or two. Automating esoteric testing. The desire for more smart systems. The need for analytics. Seven people spoke with CAP TODAY publisher Bob McGonnagle in May about chemistry and immunoassay testing. They are David Alter, MD, DABCC, of Emory University; Nina Babic, PhD, DABCC, of Medical University of South Carolina; Denise Pastore of Siemens Healthineers; Timothy Lenz, PhD, of Randox; Delena Carite of Roche Diagnostics; and Jessica Tubman, MPH, MT(ASCP), and Stephen Ishii, MT(ASCP), of Beckman Coulter. What follows is what they told us.

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Genetics lands in primary care inboxes

June 2019—It took David Ledbetter, PhD, a mere six years or so to become a hero. Dr. Ledbetter, executive vice president and chief scientific officer, Geisinger, had helped oversee the expansion of the health system’s MyCode precision medicine project, which began as a traditional research biobank in 2007.

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ME multiplex panel: debating the tradeoffs

June 2019—Meningitis and encephalitis have been called by some the most terrifying diseases in medicine, in part because of the difficulty of diagnosing their underlying pathology. The clinical stakes of laboratory testing are high for diagnosing and treating the inflammation that meningitis/encephalitis (ME) causes within the central nervous system.

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Bladder cancer detection and surveillance: How urine cell-free DNA stacks up against cytology

June 2019—A high-throughput sequencing panel was found to be more than 90 percent sensitive in detecting urinary tumor DNA in early-stage bladder cancer and in post-treatment surveillance. The approach, reported in April in Cancer Discovery, overcomes some of the challenges urinary cell-free DNA analysis poses, said one of its developers, and is far more sensitive than cytology and cystoscopy.

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Low and inside: reducing staff turnover

May 2019—When Monica Rocheford and colleagues at Allina Health Laboratory first began digging into rising turnover rates at various locales within the system, the effort carried a whiff of concern, if not urgency. One hospital site had jumped from a 10.8 percent turnover rate in 2016 to 44.9 percent two years later. At another site, turnover reached 49 percent in 2018, from 24 percent the year before. The culprit appeared to be a three-letter word: pay. “That was the main reason they were giving us for their resignation,” says Rocheford, system director, laboratory operations, recalling the exit interviews with departing staff. So in 2018, Allina, with nearly 1,000 lab employees (spread across 12 hospitals, a core lab, and roughly 60 clinics in Minnesota and western Wisconsin), awarded a technical increase across the board.

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IGHV gene mutation at heart of CLL treatment

May 2019—Chronic lymphocytic leukemia is a neoplasm of small mature B-cells and the most common leukemia diagnosed in adults. Median age of diagnosis is 70 years, but there is a surprisingly large percentage of patients, about 10 percent, who are younger than 55, and it’s not uncommon now to occasionally see CLL patients, about two percent, in their 40s.

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Mass casualty plan puts point-of-care testing in the ED

May 2019—If a mass casualty event brings patients to Le Bonheur Children’s Hospital in Memphis, Tenn., clinical laboratory staff will head straight to the bedside. Le Bonheur Children’s Hospital is a level-one trauma center. Its new mass casualty response plan, two years in the making, has laboratory staff in the emergency department and triage areas, where they will perform point-of-care testing for frontline providers.

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From CAP Press: A renewed perspective on laboratory administration

May 2019—CAP Press released this month its second edition of Laboratory Administration for Pathologists, first published in 2011. It covers management of personnel, laboratory space, pathology information systems, and quality in laboratory medicine and in the anatomic pathology lab. That’s just to start. Among its other chapters: patient safety, the pathology position, lab laws and regulations, legal affairs, ethics, and financial management of the lab and of the pathology practice. And there is more in the 296-page book edited by Elizabeth A. Wagar, MD, Michael B. Cohen, MD, Donald S. Karcher, MD, and Gene P. Siegal, MD, PhD. CAP TODAY recently asked Dr. Wagar about the latest edition; what she told us appears here, along with an excerpt (at right). Dr. Wagar is professor and chair, Department of Laboratory Medicine, University of Texas MD Anderson Cancer Center.

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AMP case report: Response to second-line osimertinib in primary EGFR p.T790M mutation

May 2019—Non-small cell lung cancer patients with epidermal growth factor receptor activating mutations have excellent response to oral therapy with EGFR tyrosine kinase inhibitors. However, development of resistance to first- and second-generation TKIs is a well-recognized phenomenon with acquired p.T790M mutation and accounts for most TKI drug resistance. Resistance to EGFR TKI therapy has been described in tumors with coexistent primary p.T790M mutation and an EGFR activating mutation in a small number of patients.

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Cytopathology in focus: Updated NSCLC guideline moves molecular cytopathology forward

May 2019—The genomic landscape of non-small cell lung carcinoma is evolving constantly with the discovery of a growing number of molecular alterations and associated targeted therapies that have an impact on patient care. The CAP, International Association for the Study of Lung Cancer, and Association for Molecular Pathology issued a guideline in 2013 to provide a road map for molecular testing to select patients for treatment with targeted tyrosine kinase inhibitors.

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Cytopathology in focus: What pathologist competencies are monitored and how

May 2019—The CAP regularly surveys the practices of the laboratories participating in the CAP Nongynecologic Cytopathology Education Program, or NGC. Members and staff of the CAP Cytopathology Committee developed a supplemental questionnaire eliciting feedback on pathologist competency activities. The Survey was mailed to 2,142 participants in the NGC-B 2018 education program. The pathologist competencies queried were as follows:

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Cytopathology in focus: Exchange of views—HPV screening policies in Australia

May 2019—In the November-December 2018 issue of the Journal of the American Society of Cytopathology is a fascinating analysis of human papillomavirus screening policies in Australia by researchers from New Zealand, a rebuttal by members of an Australian Cervical Cancer Screening Guidelines Working Party, and a thoughtful editorial by cervical cancer screening experts from the United States and England.

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Next act in genomics: the consumer orders

April 2019—For years, laboratories have chafed against testing being, literally and figuratively, an out-of-sight, out-of-mind transaction. Now a new, highly visible era in genetics may be pushing testing the other way, into the hands of consumers who value entertainment as well as medical information. Anyone who wants to write a book about this shift has a ready-made title: From Basement to Big Top. It’s not that clinical testing is becoming an actual circus. But ever since the first consumer genetic tests entered the market in 2007—in a nonphysician-ordered, SNP array technology way—labs, physicians, and regulatory agencies have had plenty to juggle.

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Quantitative image analysis: In guideline, preliminary rules for pathology’s third revolution

April 2019—With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. In setting evidence-based standards, the guideline provides background and details about the quantitative image analysis (QIA) process and the data and metadata it generates. The guideline will help facilitate pathology’s increasing use of not only digital pathology but also artificial intelligence, says Marilyn Bui, MD, PhD, chair of the CAP expert panel for QIA of HER2 IHC. “This is not just another guideline. It is a milestone for pathologists.”

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In memoriam: Harold E. Bowman, MD (1925–2019)

April 2019—Harold E. Bowman, MD, a member of the CAP Board of Governors from 1979 to 1985, died on Feb. 1 at age 93. Dr. Bowman retired in 1994 as director of laboratories at St. Lawrence Hospital, now Sparrow Hospital, in Lansing, Mich., and as associate chair, Department of Pathology, Michigan State University College of Human Medicine.

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AMP case report: Acute promyelocytic leukemia with cryptic t(15;17) identified by RT-PCR

April 2019—Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia (AML) in which promyelocytes predominate. APL accounts for about 10 percent of AML cases, and although APL can be diagnosed at any age, it is most common among young adults with a slight male predominance. APL is defined by the balanced reciprocal translocation (15;17)(q22;q21) between PML and RARA, although variant translocations involving RARA and other partner genes can occur.

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Wading deeper into liquid biopsy

March 2019—The standard riff for talking about a promising new cancer test should be familiar to anyone within sneezing distance of a laboratory: There’s no one-size-fits-all assay. But if any test were to come close, it would be liquid biopsy. Are clinicians eager to use it? Check. Is it relatively simple to do (check) with fairly quick turnaround times (check)? Does it work for solid and hematological tumors? Check and check. Across multiple specimen types—serum, urine, vitreous fluid, cerebrospinal fluid, stool? Quite likely. Can it be used to characterize patients’ molecular profiles, monitor therapy, assess tumor evolution, identify resistance mechanisms, and detect early disease and minimal/measurable residual disease? Half a dozen checks. Even if liquid biopsy does fall short of a one-size-fits-all assay, it’s doing a reasonable impression of a Swiss Army knife (if not Sergeant Troy’s sword fantastic, for those of you who are Thomas Hardy fans).  

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AMP case report: FDA-approved DNA blood test for colorectal cancer prompts patient to undergo colonoscopy

March 2019—Colorectal cancer is the third most diagnosed cancer and the second highest cause of cancer mortality in men and women, and in 2016 it accounted for about nine percent of all diagnosed cancers in the United States. When CRC is detected at an early localized stage, the five-year survival rate is 90 percent. With progression to regional disease, five-year survival remains high, at 71 percent.

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Semen analysis guide: a benchtop sperm morphology aid

March 2019—CAP Press released late last year its Semen Analysis Benchtop Reference Guide, an illustrated guide with emphasis on sperm morphology. Its 68 laminated pages are divided into sections: specimen collection and macroscopic assessment, sperm count, sperm morphology, and nonsperm cells. Behind the book is the CAP Reproductive Medicine Committee, in particular Erica J. Behnke, PhD, HCLD, of Ohio Fertility Providers, Jacob F. Meyer Jr., PhD, HCLD, of Eastern Virginia Medical School, and Laura L. Nelsen, MD, pathologist and director of cytology at MaineGeneral Medical Center and past chair of and now advisor to the committee.CAP TODAY asked Dr. Nelsen about the benchtop reference guide, sample pages of which appear below. Here is what she told us.

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Digital pathology matchmaking: people, pixels

February 2019—Digital pathology is many things. One thing it’s not is a one-night stand. As laboratories contemplate using digital pathology for primary diagnosis in the wake of the FDA’s approval nearly two years ago, it’s become abundantly clear that while digital pathology might seem to promise easy pleasure, it’s actually as complicated as keeping multiple spouses happy. Think Jacob, Rachel, and Leah. Think “Big Love.”

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No diagnostics, no stopping antibiotic misuse

February 2017—In a context where the lack of drugs against resistant bacterial pathogens will continue and antimicrobial prescriptions are highly complex, effective antibiotic stewardship programs are strongly needed. In the U.S., the CDC and Centers for Medicare and Medicaid Services highly recommend, while the Joint Commission requires, that all hospitals and nursing care centers have antimicrobial stewardship programs, effective January 2017.

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Taking measure of cholangiocarcinoma

January 2019—Ten years ago, says Manhal Izzy, MD, the approach might have seemed quixotic: performing liver transplants in patients with early intrahepatic cholangiocarcinoma. Even today, it’s hardly standard of care. Nevertheless, it has moved well beyond the impossible dream category. Medicine advances, and practices change. There’s nothing unusual about that. But Dr. Izzy, assistant professor of medicine, Vanderbilt University School of Medicine, and transplant hepatologist, Vanderbilt University Medical Center, goes out of his way to credit the wisdom and work of those in hepatology and oncology who have been pushing forward curative approaches for cholangiocarcinoma.

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Parasites in tissue: how to identify the structures

January 2019—Pathologists who aren’t microbiologists can provide a diagnosis of parasitic disease if they take into account parasite life cycles and tissue tropisms. Julie A. Ribes, MD, PhD, made that key point in cases she presented in her CAP18 session, “Update on Invasive Parasitic Infections for Surgical Pathologists.” Dr. Ribes added learning material to most of the cases, she said, but the cases come from parasites she has seen and known in her own professional life.

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AMP case report: Identification by NGS of a diagnostic and theranostic mutation in a high-grade sarcoma of the humerus

January 2019—A 75-year-old woman with history of melanoma localized to the right forearm and status post excision six years prior presented with a two-month history of continuous left shoulder pain. She was managed initially with physical therapy and hydrocodone with no effect. Initial workup at an outside institution included an x-ray of the left shoulder that showed a destructive lytic lesion involving the proximal aspect of the left humerus associated with a pathologic fracture.

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Cytopathology in focus: How can a lab ensure individual competence?

January 2019—It is happening again: CAP members and cytotechnologists are asking about regulatory requirements for re-integrating into cytopathology after a period of practice latency. That is good news because it indicates that they are interested in practicing at a time when the cytopathology community can use skilled professionals. The past decade has seen a shrinking volume of Pap tests and a concomitant decline in the number of practicing cytologists, which has created new job opportunities for those with cytopathology skills.

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Cytopathology in focus: Next-generation cytotechnology—new cytotechnologist roles

January 2019—The evolution of minimally invasive techniques and new diagnostic modalities have placed new demands on medical laboratories. Cytotechnologists find themselves uniquely poised to take on these new responsibilities, using their morphologic and analytical skills. In this article, I summarize potential roles for cytotechnologists that go beyond screening cytology slides to add value and improve quality in the clinical laboratory.

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Daniel J. Hanson, MD, 1928–2018

January 2019—Daniel J. Hanson, MD, a member of the CAP Board of Governors from 1993 to 1999, died on Nov. 2, 2018. Dr. Hanson was president and medical director of Pathology Laboratories in Toledo, Ohio, until he retired in 2005. He was also clinical professor of pathology emeritus at the University of Toledo College of Medicine.

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Rapid PCR rules as labs ready flu arsenal

December 2018—With the memory of the 2017–2018 “high-severity” influenza season fresh in mind—49 million cases, 960,000 hospitalizations, a marginally effective vaccine, 79,000 deaths—clinical laboratories have been bracing for the customary annual surge in emergency room, outpatient clinic, and physician office influenza test orders. Although flu admissions have been rising somewhat, it is too soon to know how the season will play out, but laboratories are hoping for a season closer to average. Avoiding a repeat of last year’s travails—lengthy turnaround times, supply shortages, and the need to triage patients for testing—is a must, many laboratory directors say. “We had difficulty keeping up with last year’s demand. It was extremely time-consuming,” says Mary Kay O’Connor, national laboratory director at Summit Health Management, the management arm of the Summit Medical Group, an 800-provider practice on the East Coast.

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Drug overdose deaths and toxicology tests: Let’s talk

December 2018—Drug overdose deaths in the United States continue to rise, and recently many of these deaths have been attributed to opioids, including fentanyl, fentanyl analogs, and other opioid receptor agonists. The rise in drug overdoses and drug-related deaths, and the devastating effects of the opioid crisis, highlight the need for communication and coordination among forensic pathologists, hospital clinicians, and laboratorians.  

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Higher pay for fibrinolysins interpretation in ’19 fee schedule

December 2018—The CMS finalized its 2019 Medicare physician fee schedule and its response to the CAP’s recommendations to raise payment for fibrinolysins interpretation and reporting and to forgo a proposed decrease to the physician work value for blood smear interpretation. The Centers for Medicare and Medicaid Services on Nov. 1 published the 2019 physician fee schedule. Services on the physician fee schedule are composed of three relative value units designated by the CMS: physician work, practice expense, and malpractice liability RVUs. Each RVU is separately valued and summed to equal the total RVU for each physician service on the fee schedule. The CAP advocates for the appropriate valuation of pathology services through its representation on the advisory committee of the AMA/Specialty Society Relative Value Scale Update Committee, known as RUC.

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AMP case report: Discordant IHC/PCR test results for mismatch repair status in colorectal adenocarcinoma

December 2018—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Duke University Medical Center. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Time now for tumor mutational burden?

November 2018—Like a piece of so-called sticky music, cutoff numbers can persist in physicians’ minds outside of any real clinical value and, in the process, leave their laboratory colleagues mildly befuddled (not to mention searching for more useful cutoffs). Such a jingle is creeping into tumor mutational burden. Lauren Ritterhouse, MD, PhD.

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AMP case report: Detection of concurrent hematologic malignancies in solid tumor NGS testing may cause false-positive results

November 2018—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Weill Cornell Medicine.

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Inside the Color Atlas of Mycology: Candida famata

November 2018—Color Atlas of Mycology: An Illustrated Field Guide Based on Proficiency Testing is a new book from CAP Press, released in October. It is designed to help in identifying fungi using the most recent taxonomic classifications. In it is more than 15 years of proficiency testing data to highlight diagnostic clusters of incorrect identifications and address conceptual classification issues. Following is an excerpt from the section on yeast.

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On Roche m 511 analyzer, ‘everything is done from the slide’

November 2018—Roche Diagnostics will soon launch its m 511 analyzer for hematology laboratories. Krista Curcio, Roche technical marketing manager, hematology, told us, in a recent conversation with CAP TODAY publisher Bob McGonnagle, how and why the new instrument is different. “We’re turning it upside down and going a different way,” she said of the m 511. Here is more on the instrument Roche will launch before year’s end.

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Fresh incentive to look for Ph-like ALL

October 2018—Cheryl Willman, MD, could hardly believe her eyes. She and her colleagues at the University of New Mexico, working with collaborators from across the U.S. in the NCI TARGET Project, had submitted 100 cases of high-risk pediatric acute lymphoblastic leukemia to British Columbia’s Cancer Agency for RNA sequencing to figure out why patients were doing so poorly, despite treatment with intensive chemotherapy.

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New accreditation program checklist section: Imaging mass spec scores its own quality standards

October 2018—It happened for next-generation sequencing. It was an important step for in vivo microscopy. And now it’s taking place with imaging mass spectrometry. The milestone: development and adoption of a set of specialized checklist requirements for laboratories that want CAP accreditation. Imaging mass spectrometry, an adjunct methodology to help pathologists analyze areas of interest in tissue specimens, is, at this point, used in a small number of research laboratories in the U.S., says CAP Checklists Committee member Christopher M. Lehman, MD, clinical professor of pathology, University of Utah College of Medicine, and medical director of the University of Utah Hospital Laboratory.

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New Color Atlas aids in identifying fungal species

October 2018—CAP Press released in October the Color Atlas of Mycology, by Gordon Love, MD, D(ABMM), and Julie Ribes, MD, PhD. Its 388 pages hold more than 800 tables and images, with identifications verified by DNA sequencing (for images post-2009). Here, in an exchange with CAP TODAY, Dr. Love explains how this atlas stands apart from others in the Color Atlas series and from others on the market.

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Automated molecular platforms: 3 companies on what’s new and next

October 2018—CAP TODAY’s updated guide to the automated molecular platform market begins on page 45. Thirty-four platforms are profiled, with one new one: Hologic’s Panther Fusion. Writer Valerie Neff Newitt talked with three of the 20 companies about what they introduced this year, what’s to come, and more. “This is a dynamic and competitive industry. We are always asked to go faster, and that is what we are trying to do in terms of development,” says Michelle Tabb, PhD, chief scientific officer, DiaSorin Molecular. Others seem to be doing the same.

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AMP case report: NGS in the diagnosis of RAS opathies in histologically uninformative skin biopsy samples

October 2018—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Washington, Seattle. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Shorts on Standards—Establishing cutoffs, reference ranges for biofluid biomarkers in Alzheimer’s disease: Reference materials and reference measurement procedures

October 2018—The newly developed National Institute on Aging and Alzheimer’s Association (NIA-AA) research framework uses a biological definition of Alzheimer’s disease.1 This framework has increased focus on biofluid biomarkers, especially because the measurement of cerebrospinal fluid amyloid beta peptide 42 (Aβ42) (or Aβ 42/40 ratio), phosphorylated tau protein (p-tau), and total tau proteins (T-tau) are included in the definition.1 The field of AD biofluid biomarkers is rapidly evolving. For example, CSF neurofilament light (NfL) is associated with AD neurodegeneration and may be a better CSF marker compared with T-tau.

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From the President’s Desk: Policies to protect and preserve

September 2018—CAP leadership presents a gamut of responsibilities, including the enforcement of policies adopted to protect members and staff. What I am about to discuss is relevant to all organizations and work settings. As you read on, I hope you will reflect on how tolerance for inappropriate behavior could have an impact on your own workplace and what steps you can take to protect yourself, your colleagues, and by extension your patients.

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‘We wanted to be the best we could possibly be’: CAP ISO 15189-accredited labs on the difference it makes

September 2018—Ten years ago, Richard J. Zarbo, MD, was feeling pretty proud of his laboratory. As system chairman of pathology and laboratory medicine at Detroit-based Henry Ford Health System, over the previous few years he’d seen his team rigorously implement Lean practices, practices that had paid off in greater safety and efficiency. “Setting the bar higher was important because that’s the culture here,” he says. “This is what we do.”

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Next step? The switch from stool culture to PCR

September 2018—The advantages of moving from stool culture to a molecular platform are many: faster time to results, more accurate pathogen identification, a savings of space and staff time. For Jose Alexander, MD, D(ABMM), SM, MB(ASCP), and colleagues at Florida Hospital Orlando, another plus is being able to adhere to the Infectious Diseases Society of America guideline suggestion that labs use a diagnostic approach that can distinguish O157 from non-O157 E. coli and Shiga toxin 1 from Shiga toxin 2 E. coli.

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Letters

Burnout
September 2018—As a pre-med student, I am shadowing a pathologist mentor at a major cancer hospital to gain insight into the life of physicians. She introduced me to CAP TODAY. I write in response to “Frontline dispatches from the burnout battle,” by Karen Titus (June 2018), to share the thoughts of a novice who now knows that becoming a physician means learning the skill of resiliency as early as possible.

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Microbiology’s shifting role in war on sepsis

August 2018—If you were casting about for the severest test of a laboratory’s capabilities, day in and day out, sepsis admissions at a pediatric hospital might fit the bill. At Children’s Hospital of Philadelphia, and at other hospitals, waging war on sepsis requires battles on multiple fronts and clinical pathways that rely on an agile and highly equipped microbiology laboratory. Three main categories of patients ensure there is no shortage of sepsis cases at CHOP, says Erin H. Graf, PhD, D(ABMM), director of the infectious disease diagnostics laboratory.

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Transfusion medicine checklist: Record and other requirements updated in new release

August 2018—One new requirement and several modified requirements in the CAP transfusion medicine checklist are part of the new edition of CAP accreditation program checklists released this month. In work led by the CAP Council on Accreditation, the checklists are examined anew and revised yearly, where needed. In transfusion medicine, the changes this year center on computer crossmatches, record retention, forward/reverse typing, and ABO group and Rh(D) type verification.

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Cytology workload limits: For adequacy assessments, it’s time, not slides

August 2018—The CAP and the Centers for Medicare and Medicaid Services reached an understanding earlier this year on how adequacy assessments and rapid on-site evaluations in cytology can be accounted for without causing undue impact on workload limits. The agreement, communicated to state survey agency directors in a March 16 CMS memorandum, is reflected in the updated CAP accreditation program cytopathology checklist released this month.

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Cytopathology in Focus: Synergy in cytopathology and molecular microbiology

August 2018—In today’s less-is-more world, health care consumers and providers often seek explicit and detailed information from minimally invasive procedures and tiny samples. Over are the days of “malignant cells present” and on to the next case. Cytopathologists and cytotechnologists are embracing and integrating novel techniques and applying new methods to the diagnosis and classification of essentially every imaginable form of neoplasia. The 2018 WHO publications confirm that 29 percent of deaths worldwide (more than 10 million people annually) are attributable to communicable diseases.1,2 This means the purpose of procuring many specimens is not to just rule out malignancy but also to diagnose infectious etiologies.

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Cytopathology in Focus: Why not call everything ASCUS?

August 2018—Below is a question shared on the ASC listserv. My reply to the question follows. A pathologist colleague who practiced previously as an obstetrician/gynecologist is of the opinion that categorizing the level of abnormality we observe on a Pap test is a waste of time. All the clinician needs to know, he says, is whether the test is normal or abnormal. The Pap test is a screening test, he says correctly, and its only relevance is in pointing out who needs a colposcopy and biopsy.

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Small groups, big answers in HER2 testing

July 2018—Take the new ASCO/CAP guideline for HER2 testing. Since the first groundbreaking joint guideline appeared 11 years ago, the authors have made a habit of addressing cases that flummox pathologists, medical oncologists, and patients. Now, in 2018, they have clarified the diagnostic approach to in situ hybridization groups two, three, and four, rare cases that nonetheless cause an outsized share of headaches and worries. It also clarifies language from the 2013 guideline that had sent some labs astray, and it addresses the use of multiple alternative chromosome 17 probe assays. The previous guidelines turned out to be tough acts to follow—a bit like following Sean Connery in the role of James Bond—even as the new one benefits from new data.

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Look, wait, buy: labs share instrument plans

July 2018—“Robbie,” the autonomous service robot that transfers specimens for Florida Hospital’s central laboratory, may not quite be ready for his gold watch. But after five years of faithful service delivering samples between the different esoteric testing units, he’s nearing the end of his natural lifespan with signs of wear.

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In memoriam: Harold H. Harrison, MD, PhD (1951–2018)

July 2018—Harold H. Harrison, MD, PhD, 67, Pennsylvania state commissioner in the CAP Laboratory Accreditation Program and a member of the Inspection Process Committee, died suddenly June 6 of cardiac causes. Dr. Harrison joined the Geisinger Health System in Danville, Pa., in 2007 where he was director of clinical pathology and director of Geisinger Regional Laboratories.

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For pain care and more, PGx testing at Avera Health

July 2018—Putting pharmacogenetic testing into play at Avera Health was years in the making. It took time to operationalize it at an affordable cost. Today, it has wide physician acceptance and is seen as a strong benefit for patients. “Pharmacogenetics is what will differentiate Avera in a new era of ACOs and personalized medicine, and will ultimately lead to a model for transforming health care,” says Trisha Lauterbach, MS, MLS(ASCP)CM, laboratory operations manager at Avera Institute for Human Genetics (AIHG), Sioux Falls, SD.

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Direct oral anticoagulants and APTT, PT results: The risk of normal results in patients on therapy

July 2018—With the introduction of direct oral anticoagulants (DOAC) there is a paradigm shift in the use and understanding of screening coagulation tests to determine a patient’s bleeding risk. In patients on DOAC therapy, clinicians cannot rely on normal activated partial thromboplastin time (APTT) and prothrombin time (PT) results to reflect the patient’s level of anticoagulation.

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Frontline dispatches from the burnout battle

June 2018—Bryan Bohman, MD, doesn’t spend his days wandering the Bay Area handing out buttons that read “Lift people, not the bottom line.” But don’t rule this out as a possibility someday, either. Dr. Bohman, chief medical officer, University Healthcare Alliance, and clinical professor of anesthesiology and perioperative and pain medicine, Stanford Health Care, is campaigning against physician burnout. Yes, it threatens the quality of medical care, he says, and yes, it’s expensive.

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Skirting the pitfalls of merging lab results

May 2018—“One of these things is not like the others” is a fun puzzle for kids in the context of Sesame Street. But it can be a vexing informatics challenge when you are managing data entered in fields in a database. For anyone charged with merging outside laboratory results into an institution’s electronic health record alongside results from an in-house laboratory, the differences can generate no end of headaches.

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Teaming up: how one site is managing its complex liver cases

May 2018—It didn’t take long for Heather Stevenson-Lerner, MD, PhD, to grasp one key fact about the liver biopsy cases she was seeing at the University of Texas Medical Branch, Galveston: They were often complicated. UTMB sees plenty of challenging liver cases of its own, says Dr. Stevenson-Lerner, assistant professor of medicine and liver and transplantation pathologist, Department of Pathology.

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Pharmacogenomics advocates make case for wider use

May 2018—Use of pharmacogenomic testing is still limited, despite ample research, the existence of guidelines, and the emerging evidence it can help patients. Panels can be costly and insurance coverage variable, and providers need guidance—from pharmacists, the lab, decision support alerts—in knowing what and when to order and in understanding the results. Plus, patients move.

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Clearing the air for electronic cancer checklists

May 2018—Length, cost, variability in vendor support, and lack of consistency have cast a cloud for pathologist users over the CAP’s cancer protocols and the electronic version of those protocols, the electronic cancer checklists. Work is underway to improve the user experience (Nakhleh RE, et al. Arch Pathol Lab Med. 2017;141[9]:1153–1154). Behind that effort is the undeniable: “Structured discrete data, using a controlled vocabulary, can be captured, stored, and reviewed much more readily than data in other formats,” says Mary Edgerton, MD, PhD, vice chair of the CAP’s Pathology Electronic Reporting (PERT) Committee and associate professor of pathology, University of Texas MD Anderson Cancer Center.

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With hemolysis, tackling the rush with the reasoning

May 2018—First a journey. Then sometimes a vigorous shake. Little wonder that red blood cells hemolyze. “Red blood cells don’t like to be stressed,” says Kathleen Finnegan, MT(ASCP)SH, phlebotomy training program director at Stony Brook University School of Technology and Management, New York. She instructs her students to avoid stressing the RBCs by skipping what she calls the “martini shake” (CLSI recommends five to 10 tube inversions), using a needle that is the right size, and not using a syringe for transfer but instead a transfer device. “So it’s gentle,” she says.

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Cytopathology in Focus: Reporting salivary gland cytopathology—new user-friendly Milan system consists of six diagnostic categories

May 2018—The Milan System for Reporting Salivary Gland Cytopathology was published Jan. 31 and is an important step toward standardizing the reporting of salivary gland fine needle aspiration. A large body of literature has demonstrated that FNA is an effective method for the initial evaluation of salivary gland masses, but until this year there was no uniform, widely accepted reporting system. The complexity of salivary gland cytology poses unique challenges that demand a standardized approach to communication of diagnostic information between pathologists and treating clinicians.

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Cytopathology in Focus: For thyroid cytopathology, the 2017 Bethesda System

May 2018—Surgical pathologists take their tumor nomenclature from the WHO Classification of Tumours, but cytopathologists take their terminology from where the consensus groups convened—Bethesda, Paris, Milan, and Yokohama—to formulate terminology recommendations. The Bethesda System for Reporting Thyroid Cytopathology (TBSRTC)1 is now in its second edition.

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TB testing: new approaches to old scourge

April 2018—Scratch the surface of TB testing, and things quickly get interesting. The standard skin reaction test, widely adopted by the early 1940s, is still in use today. The goal has remained steady as well: break the transmission cycle. “From the clinician perspective and the laboratory perspective, because of its infectious nature, we want to identify people with latent tuberculosis,” says Elitza Theel, PhD, lab director for the infectious disease serology laboratory, Mayo Clinic and Mayo Medical Laboratories.

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LCIS variants and DCIS: tips on telling them apart

April 2018—DCIS or LCIS? Making the distinction can be difficult in some cases. Stuart J. Schnitt, MD, in a session at CAP17 on ancillary testing in breast pathology, delineated the reasons and provided tips, including the role of E-cadherin immunostains to help in this distinction. The cells of DCIS typically show strong membrane staining for E-cadherin while the cells of LCIS are typically E-cadherin negative. But among the tips: If an in situ lesion is E-cadherin positive, it doesn’t automatically mean it’s ductal carcinoma in situ. As he demonstrated in several cases, the lesion could be lobular carcinoma in situ with aberrant E-cadherin immunostaining.

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Turnover in phlebotomy: looking deeper than pay

April 2018—Laboratory managers struggling to reduce turnover among phlebotomists should look beyond the pay and examine their hiring and management practices and the dysfunction that could be creating walls between analytical and preanalytical staff. “It’s an enormous problem,” Dennis J. Ernst, MT(ASCP), NCPT(NCCT), director of the Center for Phlebotomy Education, says of phlebotomist turnover. “There’s no silver bullet because there are so many things that lead phlebotomists to give up hope where they work and in the profession. It’s critical that managers are tuned in to the needs of this specialized workforce because they’re varied and many.”

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POC glucose: views on volume, critical care, ACOs

April 2018—Test volume, limitations on devices used in critical care, consolidation, and population health is what CAP TODAY asked about when it spoke in March with the makers of three bedside glucose testing systems. Their systems and those of two other companies are profiled on pages 44-49. “The customers are more aware than ever of the limitations that are in the package inserts from the glucose manufacturers,” says Corrine Fantz, PhD.

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Newsbytes, 4/18

April 2018—Data-extraction system demonstrates potential for pathology laboratories: Just as parents instill in their children a desire to improve themselves, in part through interactions with others, some software developers are “teaching” their tools to interact and adjust accordingly.

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Lung guideline goals: more tests, treatment

March 2018—Among the many never-ending chores that humans undertake—paying bills, filing taxes, flossing—writing medical guidelines can seem like an especially perpetual task. Just ask the architects of an updated document on molecular testing for lung cancer, issued by the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology.

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Labs take stock of surprising flu season

March 2018—In a severe flu season that started early, laboratories faced unprecedented test volumes, used new testing platforms, and negotiated vendor supply shortages. When laboratory staff at Arkansas Children’s Hospital in Little Rock began seeing a rising number of requests for respiratory tests, and five positive flu results,

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Puzzling out the positive shift in the final 14-day rule

March 2018—When the CMS’ new 14-day rule took effect Jan. 1, conditions for laboratories doing outpatient reference testing might have changed for the better. But for labs navigating the new billing regulations, some forecasters are predicting confused seas ahead. “We’ve been reaching out to a number of our customers who I know will be affected by this and saying ‘What’s your take?’ and together just putting our heads around what it really means. But there is still quite a bit of confusion out there,” says Kurt Matthes, vice president, reengineering and service, at revenue cycle management software provider Telcor.

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Inflammatory biomarkers foreshadow CKD, study finds

Baker

March 2018—The central idea of the film Minority Report—that a “precrime” police unit can predict and prevent crimes—still mostly inhabits the realm of science fiction. Luckily, in medicine, researchers studying “predisease” can make headway on prevention by analyzing the laboratory test results from samples collected years earlier, when patients showed no clinical symptoms, that might have been able to predict disorders such as chronic kidney disease (CKD) in those patients.

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Pros and cons of carbapenemase detection tests

March 2018—When it comes to diagnostic tests, everyone wants the same thing Lars Westblade, PhD, wants: A unicorn. “The diagnostic performance of a test is reflected in its sensitivity and specificity,” Dr. Westblade said. “It has to be a very good test. And then we need to think about the speed of the test.” There’s also the cost. When all these factors come together just so, “we get what’s called diagnostic perfection,” he says, or the rare event that Brandi Limbago, PhD, of the CDC calls “a diagnostic unicorn.”

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Clinical Pathology Abstracts, 3/18

March 2018—Web platform vs. genetic counselor for releasing carrier results from exome sequencing: Genomics can be used to generate a large amount of data that may have important implications for clinical care and selection of therapeutics. However, a bottleneck exists in clinical genomics due to the large volume of results and the lack of availability of knowledgeable professionals to return them to patients in person.

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New HPV guideline for head, neck cancers

February 2018—Like a pair of one-size-fits-all jeans, testing all head and neck carcinomas for human papillomavirus may have seemed like a good idea at one time. In many cases, in fact, HPV testing is just what treating clinicians and patients need. On the other hand, not every head and neck case requires it. Now, a newly published CAP guideline should help physicians figure out the right fit in multiple settings.

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Molecular tumor board: a patient with ALK– rearranged lung cancer

February 2018—A case of ALK-rearranged lung cancer was the subject of a multidisciplinary molecular tumor board presented last fall at CAP17 by pathologist Laura J. Tafe, MD, and oncologist Benjamin Levy, MD. Together they offered up insights into the tumor genomics of lung cancer with talk of testing guidelines, targeted therapies, resistance mechanisms, and circulating tumor DNA analysis.

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Smart test ordering—new program provides the tools

February 2018—A new CAP program with a novel approach makes it easier to take on an old problem: misapplied laboratory tests. The CAP Test Ordering Program, available now and complimentary to all members, is different from other laboratory test utilization initiatives, says Richard W. Brown, MD, medical director for system laboratory services at Memorial Hermann Health System in Houston.

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AMP case report: Detection of rare deletion mutation in the alpha-globin gene locus establishes a diagnosis of Hb H disease

February 2018—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Quest Diagnostics. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Procedures up to date? Fighting injury in phlebotomy

February 2018—Requiring strict adherence to the latest industry standard for venipuncture can go a long way to minimizing the risk of phlebotomy-related lawsuits and multimillion-dollar jury awards. “It revolves right back to education,” says Nancy Erickson, PBT(ASCP), an expert witness in more than 30 phlebotomy-related lawsuits. She says lack of education and failure to follow the standard of care cause the two most common patient complaints that lead to phlebotomy-related litigation: nerve damage and syncope.

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AP-LIS vendors talk reports, interfaces, protocols

February 2018—Customer demand, cancer protocols, and consolidation of pathology practices are some of what CAP TODAY asked about when it spoke in January with four anatomic pathology computer system companies. Their AP systems and those of 17 other companies are profiled in the anatomic pathology computer systems interactive product guide. “It’s a really good time for our market right now,” says Joe Nollar of Xifin, “and systems providers need to be creative in helping their clients get the solutions they need to be scalable, competitive, and profitable.” Here is more of what they told writer Anne Ford.

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For precision medicine, next-generation mass spec

February 2018—The modern analytical technologies of mass spectrometry continue to garner prominence and broader utility in clinical diagnostics. This was showcased at the 7th Annual American Association for Clinical Chemistry Conference on Mass Spectrometry and Separation Sciences for Laboratory Medicine, held last fall in Philadelphia. Representatives of academia, industry, and regulatory bodies came together to share information about the technology and best practices, the aim of which is to strengthen clinical diagnostics for the betterment of patient care. In opening remarks, then CAP president Richard Friedberg, MD, PhD, shared his hopes for the future of mass spectrometry in anatomic pathology.

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Put It on the Board, 2/18

February 2018—PreludeDx unveils predictive assay for DCIS: PreludeDx announced results from its oral presentation at the San Antonio Breast Cancer Symposium. The results using the SweDCIS randomized trial confirmed that the DCIS­ion­RT test predicts which patients with ductal carcinoma in situ will benefit from radiation therapy after breast-conserving surgery.

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Clin Lab 2.0: Add value, make patients better

Clin Lab 2.0: Add value, make patients better

January 2018—It was baseball’s Yogi Berra who said, with the unique slant that was his hallmark, “In theory there is no difference between theory and practice. In practice, there is.” More vividly, boxer Mike Tyson once summed up the same reality when asked to comment on an opponent’s strategy in an upcoming match: “Everybody has a plan—until they get hit.”

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Next-gen sequencing finds further clinical utility in oncology

January 2018—One of the plenary sessions at the 2017 meeting of the Association for Molecular Pathology—“High Impact Molecular Diagnostics for Cancer and Inherited Diseases”—was a virtual mini-course in the latest and most useful applications of next-generation sequencing to detect germline and somatic mutations in cancer. Both speakers zeroed in on the clinical utility of their innovative diagnostic techniques.

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Devices, decisions: POC glucose in the critically ill

January 2018—Using point-of-care glucose meters in critically ill patients can feel like tiptoeing through a regulatory minefield. Perhaps your preferred meter hasn’t been cleared by the FDA for use in this population. Or maybe you’re not sure which assay performance requirements should be regulating the performance of your meters. Or perhaps you’re still trying to define “critically ill.”

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AABB seeks comments on form to streamline transfusion adverse reaction reporting

January 2018—The AABB is seeking comments by March 30 on its common transfusion reaction reporting form, the seven pages of which are presented online at www.bit.ly/AABB-reportform. The fillable PDF form is intended to be used by hospitals and blood centers to communicate information about transfusion reactions to the blood supplier, particularly when there are multiple suppliers to the hospital transfusion service.

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Cytopathology in Focus: Standardized reporting for breast FNAB cytology

January 2018—In countries with developed medical infrastructure, the use of breast fine-needle aspiration biopsy (FNAB) cytology has had its share of challenges over the past 20 years, among them the use of core needle biopsies. In developing countries where the use of FNAB cytology has been increasing rapidly, breast lesions are one of the most common sites sampled by FNAB. In 2016, the International Academy of Cytology Executive Council put together a “Breast Group,” which consists of cytopathologists, surgical pathologists, radiologists, surgeons, and oncologists working in breast care, with the aim of producing a comprehensive and standardized approach to breast FNAB cytology reporting.

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Cytopathology in Focus: A right and a wrong way to use CAP educational kits

January 2018—The CAP Cytopathology Committee constructs educational and interlaboratory comparison kits that are distributed regularly to cytotechnologists, cytopathologists, and pathologists who want continuing education in cytopathology. The purpose of the kits is to make it possible for those who screen and diagnose cytology slides to maintain and update their skills. However, the Cytopathology Committee has been made aware that the kits have been employed for purposes other than education. We address here the potentially detrimental uses to which some laboratories are putting these educational kits and advise laboratories to use them only as they were intended.

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Cytopathology in Focus: HPV vaccines: the decade in review

January 2018—Diane Harper, MD, MPH, and Leslie DeMars, MD, provide an extensive review of the efficacy of available FDA-approved HPV vaccines in different age groups and describe immunogenicity findings in particular (Gynecol Oncol. 2017;146:196–204). The World Health Organization and the Centers for Disease Control and Prevention recommend a two-dose vaccine for younger children due to high rates of seroconversion and antibody titers in this age group. Girls age 15 and older should continue to get three doses.

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Hopes, fears as users switch to new troponin

December 2017—The questions that arise over the use of highly sensitive cardiac troponin are as riveting as, if less historically fraught than, the Jefferson-Hamilton debates over the shape of their newborn country. Who should lead—the states or a strong central government? Cardiologists or the emergency department? What cutoffs represent the right balance between admissions, referrals, and sending patients home? And will Lin-Manuel Miranda ever write a smash musical about this cardiac assay?

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In hemostasis, two hot-button testing issues

December 2017—Having validation data to support the use of age-adjusted D-dimer cutoffs with the D-dimer assay your laboratory uses is a must, and know well the limitations of point-of-care prothrombin time/INR testing. That advice and more was shared in a “Hot Topics in Hemostasis” session at CAP17, presented by Russell Higgins, MD, and Karen Moser, MD.

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‘Connectathon’ opens door to interoperability in digital pathology

December 2017—With the FDA having approved whole slide imaging for primary diagnosis this year, one obstacle to full acceptance of digital pathology remains: lack of interoperability. To topple that barrier, the Digital Pathology Association, the CAP through its Digital Pathology Committee, and DICOM Working Group 26 convened in October, during the Pathology Visions conference, the first Connect­athon for digital pathology.

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HbA1c shows its mettle in predicting diabetes risk

December 2017—The longitudinal Framingham Heart Study, which first identified the concept of risk factors and made serum LDL cholesterol a household name, could help increase the celebrity status of HbA1c, with the Oct. 26 publication of a new study in Diabetes Care. International and national organizations since 2010 have recognized HbA1c as a valid way to diagnose abnormalities in glycemia and diabetes mellitus. But there has been less consensus on its use as a screen for elevated diabetes risk.

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Higher pay for therapeutic apheresis, bone marrow aspiration

December 2017—For 2018, CMS estimates a one percent overall decrease in pathology reimbursement. Pathologists will receive payment increases for therapeutic apheresis and diagnostic bone marrow aspiration services in 2018. At the same time, reimbursement for flow cytometry services will continue to decrease following phased-in reductions set by the Medicare program last year, but the CAP was successful in lessening the impact of cuts to those services in 2018.

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Are point-of-care PT/INR devices safe and effective?

December 2017—Safety issues related to point-of-care PT/INR testing surfaced in recent years, among them a 2016 voluntary class 1 recall of Alere’s INRatio and INRatio2 monitor systems. “Prior to that, the company that manufactured the device had received thousands of complaints about it,” says Russell Higgins, MD, of the University of Texas Health Science Center at San Antonio.

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Class act in Ohio expands pool of phlebotomists

December 2017—After two rounds of a new program to train high schoolers in phlebotomy, OhioHealth is seeing the fruits of its efforts. It has hired 19 of its trainees and a third course, set to begin next month, has 20 high school seniors enrolled. Just when OhioHealth’s phlebotomy staffing needs were expanding, laboratory services leaders were growing increasingly dissatisfied with the quality of the training students were receiving at most of the phlebotomy programs in the Columbus area.

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Next-gen troponin: out of the gate, into labs

November 2017—The story of highly sensitive cardiac troponin, as written by Dr. Seuss, would provide a small twist. In this version, the Grinch doesn’t steal Christmas. Rather, he keeps delaying it, quarter after quarter, year after year. “I remember maybe seven years ago, Roche told me their assay was coming. It’s coming, it’s coming, it’s coming,” laughs Sihe Wang, PhD, medical director and section head, clinical biochemistry, Cleveland Clinic, and clinical chemistry professor, Cleveland State University.

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Benefits and bumps of shifting to Beaker

November 2017—If they were located in the Land of Oz, laboratories selecting a laboratory information system might not have to make a choice between full functionality and seamless integration with their electronic medical record system. They could just follow the helpful advice of the Scarecrow to Dorothy at a crossroads: “Go both ways.”

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LIS niche modules flourish amid IT consolidation

November 2017—“There’s an app for that” was a common, if flippant, catch phrase to suggest that a software solution had already been devised for just about every need (at least until 2010, when Apple trademarked the catch phrase). In the laboratory industry today, you are likely to hear more references to software’s “functionality,” but the concept is the same. While debate continues over whether best-of-breed products or comprehensive information technology systems should rule the laboratory, health care IT companies have developed a profusion of modules or ancillary applications—sometimes packaged with an LIS, sometimes sold separately—to fill software gaps.

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With syphilis rates rising sharply, syphilis tests a focus

November 2017—Syphilis is making a comeback. Nearly 28,000 cases of primary and secondary syphilis, the most infectious stages of the disease, were reported in the U.S. in 2016—a 17.6 percent jump over 2015 and the highest reported rate since 1993. Cumbersome, subjective nontreponemal assays and the lack of a gold standard screening method lend complexity to the diagnostic process. But new nontreponemal assay options, including the first FDA-cleared fully automated treponemal/nontreponemal dual assay, may help stem the rising tide.

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AMP case report: Follicular lymphoma of gallbladder, November 2017

November 2017—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Western University and London Health Sciences Centre, London, Ontario, Canada. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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‘Split’ decisions in CNS tumor update

October 2017—Classifying central nervous system tumors has recently become both more complex and easier. Surgical pathologists now have guidance that helps them work through the whys, hows, and what-ifs of using molecular studies when making diagnoses. The 2016 WHO classification for CNS tumors, which has been described as a conceptual and practical advance over the previous incarnation, from 2007, should also help them move closer to precision medicine.

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Revived hopes, fresh challenges with liquid biopsy

October 2017—Until recently, new treatments for stage 4 lung cancer have generally required weighing toxicity against hopes that patients’ average length of survival might be extended by a month or two. But “our expectations are increasing as therapies have improved,” says Geoff Oxnard, MD, thoracic oncologist at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School. “Patients and doctors are increasingly expecting targeted therapies with dramatic effect and few side effects.”

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PD-L1 guideline panels hustle to keep pace with drug advances

October 2017—The expert and advisory panels for the CAP/IASLC/AMP guideline on molecular testing for lung cancer biomarkers started updating the guideline in 2014, and an important but fairly routine revision process may have seemed to lie ahead. Something like sedately stepping onto a moving sidewalk. The key question at that point was quotidian: Have new data emerged to warrant changing the original recommendations?

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How to spot the savings from a diagnostic team

October 2017—Few pathologists and laboratory professionals would argue with the potential clinical benefit of a diagnostic management team, a group that meets often and provides timely patient-specific reports that synthesize all test results. But getting C-suite executives on board may mean uncovering whether such a team can save the hospital money.

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Recommendations for investigating liver chemistry abnormalities are unworkable

October 2017—A new guideline on the evaluation of abnormal liver chemistries was published in the January 2017 issue of the American Journal of Gastroenterology (AJG).1 The guideline, developed by the American College of Gastroenterology’s practice parameters committee, is based on three resources, the first of which is a review of published research. The other two resources are notably similar and largely based in expert opinion.

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DIY or Survey? Identifying interfering substances

October 2017—The interfering substance: Whether it’s in-laws on your doorstep or lipemia in your specimen, it has to be addressed. Ask Michelle K. Zimmerman, MD. These days, Dr. Zimmerman uses the CAP Interfering Substance Survey to detect the presence of hemolysis, lipemia, and icterus in clinical chemistry samples at Indiana University School of Medicine, where she is an assistant professor of pathology and laboratory medicine. But before her laboratory started using the Survey, how did it handle those interferences?

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AMP case report: Primary pulmonary adenocarcinoma with an unusual molecular profile of the EGFR gene at initial presentation, October 2017

October 2017—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Massachusetts Medical School-Baystate, Springfield. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Sigma analysis, role and limitations: development of a QC program for the Beckman Coulter AU5812

October 2017—The challenge for all clinical laboratories is to produce the highest quality in vitro diagnostic results in the most efficient manner. Fortunately, high quality and high efficiency are not mutually exclusive, and the direct correlation between the two is well documented.1,2 As the quality of processes increases, so does process efficiency, which ultimately drives down costs.

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New tests, new wrinkles in HIV algorithm

September 2017—Three years—including a total eclipse of the sun—have sped by since the Centers for Disease Control and Prevention and the Association of Public Health Laboratories recommended a new HIV diagnostic testing algorithm for laboratories. In 2014, the algorithm was seen as bringing HIV test ordering up to speed with the advances in HIV test technology and increasing the accuracy and reliability of HIV screening and diagnosis. Have laboratories made the adjustment, and is the CDC/APHL algorithm proving workable and worthwhile?

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Turning points in transgender medicine

September 2017—The intricacies of transgender medicine are many. They are unique; they are universal. A la Walt Whitman, they contain multitudes: identities, challenges, questions, even fears. But the first step toward comprehending them can be simple. Tim Cavanaugh, MD, started with a cup of coffee. Dr. Cavanaugh, of Fenway Health, Boston, began delving into the topic about a decade ago, when an assistant administrator at his previous job, at a small community health center in Rhode Island, told the center’s leaders that the transgender population was medically underserved.

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Market based? A view of PAMA process, pricing

September 2017—Under the Protecting Access to Medicare Act of 2014, Medicare rates for laboratory tests will be recalculated to reflect “market-based pricing” as reported by “applicable laboratories.” But are labs going to get a market-based price, or is the Centers for Medicare and Medicaid Services “gaming the system to ensure there will be a cut to the fee schedule”?

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New requirement, updates in transfusion checklist

September 2017—Like an old friend with a new facelift, or a high-mileage car with a thorough tune-up, the 2017 edition of the CAP transfusion medicine checklist has undergone a significant number of small changes—none of which is startling in itself, but all of which combine to produce a fresh and streamlined effect. More than 90 of the checklist’s requirements have been revised, many in the name of alignment with FDA requirements.

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Making it personal: transgender medicine

August 2017—Talk about personalized medicine. While the national discussion about transgender women and men often pivots on civil rights legislation (exhibit A: so-called bathroom bills), the medical community has quietly begun to ask questions about how to provide care for transgender patients. In the process, assumptions are being turned sideways. And as laboratory professionals are realizing, the impact can affect everything from start (patient identification, test ordering) to finish (test results, billing), seemingly one patient at a time.

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A slimmer molecular micro section among changes to checklists

August 2017—There was no trip to the spa. But some sections of the 2017 edition of the CAP Laboratory Accreditation Program checklist are looking trimmed and toned compared with last year’s checklists. A microbiology section that is shorter by eight pages, fewer Individualized Quality Control Plan reporting requirements, and a new section addressing chain of custody once again reflect the hard work of the Checklists Committee and scientific resource committees to achieve conciseness and clarity.

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In digital age, new focus on specimen, slide prep

August 2017—The age of FDA-approved whole slide imaging for primary diagnosis has dawned with opportunity for every level of professional who works in the digital pathology environment. It includes not only an expanded professional cachet but also great potential born of collaborative and remote capabilities, and perhaps better patient outcomes as a result.

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Ownership remix as hospitals, national labs jockey for position

August 2017—In the game of Risk, dominating the board hinges not only on clever strategy but also on rolls of the dice. In the real-world game that is the enormous laboratory market, there is a parallel: Rationally calculating the profitability and risk of mergers or acquisitions is crucial, but many such business moves involve a gamble. Right now, the main thing the laboratory industry appears to be betting on is upheaval.

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AMP case report: NGS panel aids in diagnosis of rare collision tumor, August 2017

August 2017—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Columbia University Medical Center. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Laboratory director duties clarified in 2017 checklist

August 2017—Quantum theory is often interpreted to mean an object can be in two places simultaneously. Unfortunately, quantum theory doesn’t apply to laboratory directors, at least not on a scheduling level. Like the rest of us, directors can be in only one place at a time, no matter how many laboratories they oversee. Now a change to the CAP Laboratory Accreditation Program’s checklists will clarify expectations for directors who are in charge of more than one laboratory. The 2017 edition of the checklists, released this month, has eliminated the specific requirements for laboratory directors who are not on site full time and has clarified responsibilities for all directors, on site or remote.

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Cytopathology in Focus: Cell Blocks: Getting the most from the least invasive method

August 2017—Adequate and high-quality cell block preparations can be a useful adjunct to cytologic smear preparations and touch imprint cytology. Adequate cell blocks allow for additional studies and can provide a specific diagnosis and information essential for targeted treatment plans. Cell blocks can be prepared from most cytology specimens such as fine needle aspirations, body cavity fluids, washings, brushings, and gynecologic and nongynecologic liquid-based specimens.

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Cytopathology in Focus: Closing cytopathology, cytotechnology practice gaps—three years later

August 2017—The CAP has focused during the past 10 years on facilitating the transformation of pathology practices from the instrumentation age to the information age, with a concentration on personalized medical care and laboratorians as integral members of the health care team. Hand-in-hand with that effort, the CAP Cytopathology Committee has advocated for the expanded use of cytology specimens in molecular diagnostics and the evolution of the cytotechnology workforce to meet the emerging practice gaps as pathologists become engaged in ever more complex diagnostic processes.

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Volume, value, technology steering 2017 instrument buys

July 2017—For at least some laboratories, economic conditions and capital flows are calling for a cautious approach to purchasing new laboratory instruments. As one analyst of the clinical laboratory services industry was heard to say recently: “Because of tight capital, nobody is buying anything unless it breaks.” But laboratory executives and medical directors at some of the nation’s largest health systems in the Northeast, West, and Midwest take a different view.

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Hepatic neoplasms—cases, challenges, cautions

July 2017—Kisha Mitchell Richards, MBBS, once took a picture of the ocean as she went around a bend in the road traveling from Negril to Montego Bay in Jamaica. She showed that photo in the second half of a CAP16 session to prepare the audience to shift gears, as she put it, from the first speaker’s talk on medical liver disease (see “Liver injury patterns: pitfalls and pointers,” March 2017) to hers on hepatic neoplasms. “So for me, we are about to go around a bend to things of sheer beauty,” she said, referring to immunohistochemistry stains in the neoplastic liver. “Unfortunately, that which is beautiful to the pathologist is not often great for the patient. That’s our usual practice,” said Dr. Richards, a pathologist at Greenwich Hospital, Yale New Haven Health, Greenwich, Conn.

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Hepatocellular adenoma subtypes—Which is it?

July 2017—Kisha Mitchell Richards, MBBS, a pathologist at Greenwich Hospital, Yale New Haven Health, Greenwich, Conn., recalls that when she was a resident, adenoma was just adenoma. “Nowadays it’s not quite where breast is, where it’s a two-page report, but there are now subtypes of hepatocellular adenomas,” she said in a CAP16 presentation on liver neoplasms. The subtypes are the HNF1 alpha or TCF1 inactivated adenoma, inflammatory adenoma, beta-catenin mutated adenoma, and the unclassified adenoma, which she notes is basically adenoma NOS (not otherwise specified).

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Integrative consults remove referral inefficiencies

July 2017—Inappropriate referrals to rheumatologists and months-long wait times led pathologists to start a service at Harris Health in Houston of consultative-algorithmic workups for rheumatologic disease. “Everyone liked it. Rheumatologists were happy to get patients they could treat and who were already worked up,” Robert L. Hunter, MD, PhD, says of the service that gave primary care providers the option of selecting algorithmic testing with pathologist consultation rather than order individual tests when signs and symptoms suggested rheumatologic disease.

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New pathology patient consult program takes off

July 2017—Ten weeks in, 10 patients seen. The pathology patient consult program at Lowell General Hospital is already giving a boost to pathology’s visibility and patients a better understanding of their disease. Lija Joseph, MD, chief of pathology and medical director of pathology and laboratory medicine at Lowell General Hospital in Lowell, Mass., says a colleague’s presentation about social media and medicine led her to launch the patient pathology consult program in March.

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15th phlebotomy edition holds ‘latest, greatest’

July 2017—After overseeing 10 editions of So You’re Going to Collect a Blood Specimen: An Introduction to Phlebotomy, Frederick L. Kiechle, MD, PhD, can authoritatively say that the 15th edition is the best. Released in March, this edition provides new information on ultrasound-guided peripheral intravenous cannulation, comprehensive instructions on proper hand hygiene, and a deeper dive into quality assurance.

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Diagnostics anchor freestanding ED

June 2017—To the business world, “appropriate technology” may evoke the era of tie-dyed shirts, bead curtains, and Mother Earth News. But the term, coined by Small Is Beautiful author E.F. Schumacher in 1973, comes close to describing the goal of health care systems as they opt to expand their facility footprint with freestanding emergency departments (FSEDs).

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New scope for trial drives FDA verdict

June 2017—The new FDA-enabled milestone in pathology—approval in April of whole slide imaging for primary diagnosis—allows pathology to dip its toe into the technological revolution that has already transformed other fields. Widespread adoption will take time, training, and money, but it no longer awaits breakthrough approval.

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From the President’s Desk: Speaking of optics, 6/17

June 2017—We typically define “normal” or “true” from the perspective of our local communities and social circles. This reliance on the familiar can compromise communication effectiveness when we don’t appropriately consider the audience. And as the exchange of information continues to accelerate, the impact on what constitutes an authoritative assessment evolves similarly. Sometimes we don’t stop to think.

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Kevin B. Dole, MD | 1948–2017

June 2017—Kevin B. Dole, MD, 68, a member of the CAP Board of Governors from 2001 to 2007, died April 23 of metastatic pancreatic cancer. He had served as a member of the Councils on Government and Professional Affairs and on Public Affairs and as chair of the Council on Membership and Professional Development. He was a member of more than a dozen committees, among them Credentials, CLIA Implementation, Practice Guidelines, and Federal and State Affairs (which he chaired). He was named Pathologist of the Year in 2009.

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Book surveys patient safety from AP, CP standpoint

June 2017—CAP Press released in May Patient Safety in Anatomic & Clinical Pathology Laboratories. Editor Deborah Sesok-Pizzini, MD, MBA, and 11 additional contributors cover handoff communications, technology, tools and methods, human factors, a patient safety curriculum, and more. Dr. Pizzini is chief of blood bank and transfusion medicine in, and vice-chief of, the Department of Pathology and Laboratory Medicine, Children’s Hospital of Philadelphia. She is the department safety officer for CHOP Pathology and Laboratory Medicine, and she is a professor of clinical pathology and laboratory medicine, Perelman School of Medicine, University of Pennsylvania. We asked her about the new book. Here is what she told us.

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Pathologist Cognition

June 2017—In the chapter “Diagnostic Errors and Cognitive Bias” in Patient Safety in Anatomic & Clinical Pathology Laboratories, Stephen S. Raab, MD, writes about pathology work process and cognitive failures, pattern recognition and cognitive strategies, interpretive error, and mitigation and improving safety. Here is his section on pathologist cognition. Dr. Raab is a professor of pathology at the University of Mississippi Medical Center, Jackson.

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Helping phlebotomists ease pediatric patient anxiety

June 2017—“It’s the most talked about pain kids experience, even more so than post-op surgical pain.” Julie Piazza, a certified child life specialist, is referring to needlestick pain from pediatric blood draws. As project manager for patient and family-centered care at C.S. Mott Children’s Hospital in the University of Michigan health system, now known as Michigan Medicine, Ann Arbor, Piazza has observed anxiety at both ends of the needle.

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Life-threatening bleeding—what’s the right call?

June 2017—In the CAP16 session, “Your Turn: Management of the Bleeding Patient,” Theresa Nester, MD, reminded attendees who provide transfusion medicine consultation to assess the available information before calling the clinical team: patient history, drugs, coagulation test results, and products administered so far. “Your main role is to help determine why the patient is bleeding and the most appropriate treatment,” said Dr. Nester, medical director of integrated transfusion services at Bloodworks Northwest in Seattle.

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Emergency hemorrhage panel gives surgeons what they need

June 2017—As an alternative to point-of-care testing, Wayne Chandler, MD, and colleagues developed and implemented a rapid emergency hemorrhage panel, or EHP, for trauma patients (Chandler WL, et al. Transfusion. 2010;50[12]:2547–2552). The panel tests are prothrombin time, hematocrit, fibrinogen, and platelet count. “By limiting EHPs to patients that were actively bleeding, EHPs accounted for only 8 of 243 coagulation samples per day,” he and colleagues wrote in their 2010 article.

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Acute leukemia workups, from top to bottom

May 2017—Plenty can happen in five years. Just ask Cubs fans who watched their team leap from a 101-loss season in 2012 to a 103-win season in 2016 and a World Series title as the cherry on top. Or ask Daniel Arber, MD, who co-chaired a hefty new guideline—a half decade in the making—on diagnostic workup of acute leukemia. At the start of the project, “I think everyone going into it realized it was going to be a time-consuming, long process. But I don’t think anyone realized how long,” says Dr. Arber, professor and chair of pathology, University of Chicago, and the CAP co-chair for the guideline group.

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TLA in, volume up—micro labs take stock

May 2017—Rise of the Robots. Disruption. Humans Need Not Apply. “The Future of Work.” A flood of books and articles in the past several months make the argument that service industries in the U.S. hover on the brink of total automation and humans will have to figure out how to adapt. Forty-five years ago, when Michael R. Jacobs, MD, PhD, started in microbiology, people fantasized about microbiology reaching this stage.

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Whole slide imaging for primary diagnosis: ‘Now it is happening’

May 2017—When the Food and Drug Administration granted permission to Philips to market its whole slide imaging system for primary diagnosis last month, it was a “big deal” of the highest order. “Yes, this is a very big deal,” says Liron Pantanowitz, MD, a professor of pathology and biomedical informatics at the University of Pittsburgh Medical Center. “This event will provide the impetus to drive digital pathology forward for clinical use in the U.S., and allow us to catch up with our colleagues around the world who are ahead of us in their digital transformation journey.”

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Study ‘opens the door’ to troponin, diabetes link

May 2017—Clinicians and laboratories have only begun to wade into the depths of the FDA’s long-awaited clearance of a new-generation, high-sensitivity cardiac troponin T (hs-cTnT) assay for rapid diagnosis of acute myocardial infarction. Roche’s Elecsys TnT Gen 5 STAT assay received just such clearance in January. Yet researchers are already deep into investigations that may float new opportunities for high-sensitivity troponin T testing to the surface of medical diagnostics.

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In memoriam: Richard E. Horowitz, MD | 1931–2017

May 2017—Richard E. Horowitz, MD, a member of the CAP Board of Governors from 1997 to 2000, died March 15 at age 85 of complications from lung cancer. Dr. Horowitz is a past member of the CAP’s House of Delegates and the CAP’s Practice and Education, Government Affairs, and Public Affairs councils. He was chair of the Outcomes and Performance Measures committees and a longtime member of the Committee on Computerized Laboratory Systems. He was a member, vice president, and president of the CAP Foundation Board of Directors.

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In flu season management, POC molecular to the fore

May 2017—Stacked against some of the nation’s previous bouts with influenza—such as the 2014–15 season—the 2016–17 flu season didn’t break records for drama. To be sure, every flu season is different, and regional variation was prominent. In Central Texas, some outbreaks appeared to start later than usual, but the dominant viruses were the same as last year’s—H1N1, H3N2, and influenza B—says Bob Fader, PhD, chief of the virology and microbiology laboratory at Baylor Scott & White Health, Temple, Tex. The strains identified were a good match with this year’s trivalent and quadrivalent vaccine. Testing volume was up, as were positive PCRs.

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How billing systems profit from analytics and automation

May 2017—The laboratory financial systems of yesteryear were built to deliver on a prime directive: achieve optimal, timely payment. Fast-forward to today and the overriding goal remains largely the same, but the means to the end has become more sophisticated, with billing/accounts receivable/revenue cycle management systems providing capabilities to recover outstanding payments, pinpoint reimbursement bottlenecks, and deliver a diverse range of data.

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For C. difficile, lab assessment alone is not enough

May 2017—Toxigenic Clostridium difficile can be isolated in about one-third of hospital rooms in which there is no patient with C. diff infection, and the same is seen in the community. A study published in 2014 found that 32 percent of the samples obtained from 30 houses in Houston were culture-positive for toxigenic C. diff. And C. diff was isolated from 83 percent of the houses.

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No perfect approach to detecting C. diff infection

May 2017—With Clostridium difficile causing a wide range of infectious manifestations, the dilemma for clinical laboratories is how to balance the different diagnostic options. “Because if you’re treating someone who is only colonized, you’re not going to benefit them—and very likely you may harm them,” said Ferric C. Fang, MD, professor of laboratory medicine, Department of Microbiology and Medicine, University of Washington School of Medicine, Seattle, in a recent webinar hosted by CAP TODAY and sponsored by BioFire. And having a negative toxin assay is no assurance, he said, that C. difficile is not causing disease.

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Cytopathology in Focus: More aggressive follow-up for patients with AGC?

May 2017—The most recent edition of the Bethesda System for Reporting Cervical Cytology classifies glandular cell abnormalities into the following broad categories: atypical (specify favored site of origin), atypical (favor neoplastic), endocervical adenocarcinoma in situ (AIS), and adenocarcinoma.1 Generic terminology of “atypical glandular cells (AGC)” may be used if the origin of the cells cannot be determined with certainty. Nevertheless, the Bethesda System encourages pathologists and cytotechnologists to report the favored site of origin (endometrial versus endocervical) whenever possible.

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Cytopathology in Focus: Integrating cytology samples into molecular testing of tumors

May 2017—Use of cytology specimens for molecular testing can spare patients from repeated or more invasive procedures. A two-part special section in recent issues of Archives of Pathology & Laboratory Medicine highlights a variety of applications of molecular techniques in cytopathology specimens. The articles in this section cover laboratory workflow issues, considerations for the preparation of cell blocks, application of immunoperoxidase staining and FISH to cytology specimens, and specific applications of molecular testing in thyroid and lung specimens.

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Cytopathology in Focus: Paris System for urinary cytology: why and where now

May 2017—It is well known that examination of urine dates back to antiquity, but it wasn’t until the 19th century that cancer cells were microscopically documented in urine, by Hermann Lebert in 1845 and Vilem D. Lambl in 1856. Over many decades, countless talented and noteworthy authors have contributed valuable observations and conceptual mechanisms to the study of urinary cytology, but a systematic, universally accepted, internationally recognized system with clear goals was missing.

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New autopsy book ‘a complete learning experience’

May 2017—Autopsy Performance & Reporting is a new book from CAP Press, released in April. The editor, Kim A. Collins, MD, and her 43 contributors wrote 40 chapters on facility design, safety, high-risk cases, the oral cavity, the placenta, the pediatric autopsy, special studies of the heart and lungs, postmortem microbiologic testing, photomicrography, and much more. “I know of no other autopsy book like this on the market,” Dr. Collins tells CAP TODAY.

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Pregnancy-related death: Hepatic System

The chapter in Autopsy Performance & Reporting titled “Pregnancy-Related Death and the Autopsy Examination” is written by Cynthia Schandl, MD, PhD, of Medical University of South Carolina. Here from that chapter is an excerpt (published without references) on the hepatic system. Dr. Schandl’s chapter also covers the cardiovascular, respiratory, hematopoietic, urogenital, and endocrine systems, as well as the gastrointestinal tract and skin and connective tissue.

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New molecular road map for CRC

April 2017—Molecular testing for colorectal cancer is not for the faint of heart. While that’s not news to Stan Hamilton, MD—he’s head, Division of Pathology and Laboratory Medicine, and the Frederick F. Becker distinguished chair in cancer research, University of Texas MD Anderson Cancer Center—he was reminded of this fact recently when a friend looked at the multipage molecular pathology report on his own tumor.

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With cloud computing, sorting out pros, cons

April 2017—“No man putteth new wine into old wineskins” reads the biblical aphorism in Luke 5:36–39, which continues by giving the reason: “The new wine would burst the skins and be spilled, and the skins would perish.” Old wineskins, biblical scholars say, would typically be stretched to the limit or become brittle as wine had fermented in them.

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Primary aldosteronism: diagnostic team lifts clinical practice

April 2017—For decades, Michael Laposata, MD, PhD, chair of pathology at the University of Texas Medical Branch in Galveston, has touted the value of diagnostic management teams, and in February he led the first conference dedicated to such teams, referred to as DMTs. There, Alison Woodworth, PhD, told the story of how and why she created a DMT for primary hyperaldosteronism, what it achieved, and where her DMT focus is now.

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Hemophilia management: Tips on monitoring modified replacement therapies

April 2017—Some modified recombinant factor VIII and IX products for hemophilia prophylaxis show significant reagent-dependent recovery in the one-stage assay, while recovery in the chromogenic assay appears to be more consistent, especially for modified recombinant factor IX. The variable results can lead to over- or underestimating the factor level, warn Stefan Tiefenbacher, PhD, of Colorado Coagulation, and Rajiv K. Pruthi, MBBS, of Mayo Clinic.

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Assessing LPL software

April 2017—Twenty years ago, CAP TODAY released its first product guide for laboratory-provider links software. The demand for connectivity was growing as laboratories built their outreach business, and the future looked bright for LPL software companies.

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New rays on blood safety

March 2017—The language of blood banking experts, as they talk about irradiators, transfers easily to a car dealership. How reliable are the newer models? Are you willing to replace it every 10 years or so? Do you keep running it until it dies? What parts are likely to burn out? What will repairs run? And then the word “terrorism” pops up.

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Cell-free DNA screening blooms in expansion to low-risk pregnancies

March 2017—Something about having the letters “DNA” in a test’s name may make the test seem like the last word, the key to a black-and-white, definitive diagnosis. That connotation has been problematic for cell-free DNA sequencing used for noninvasive prenatal testing, because the test is not intended or designed for diagnosis, but only for screening. It’s for that reason, in fact, that some maternal-fetal medicine specialists and clinical geneticists prefer to use the term “noninvasive prenatal screening,” with the acronym NIPS.

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HbA1c in CVD treatment: farewell to one size fits all

March 2017—Anchor. Central pillar. Cornerstone. It would be hard to find a weighty synonym for “linchpin” that hasn’t been used to describe HbA1c’s role in diabetes diagnosis and management since 2010, when the assay was recognized by key standard-setting organizations as the equal of fasting glucose and oral glucose tolerance testing in diabetes and prediabetes testing.

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Latest TB testing guide set forth by ATS, CDC, IDSA

March 2017—Testing for latent Mycobacterium tuberculosis infection and active tuberculosis disease remained relatively unchanged for many years. Screening for latent infection depended on an initial positive tuberculin skin test, and evidence for active TB required a positive culture for M. tuberculosis complex. New tests altered this picture in the past five years. For diagnosis of latent infection, interferon-gamma release assays have taken a major role. And nucleic acid amplification testing is becoming a mainstay for establishing a diagnosis of TB.

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In cancer sequencing, a new lingua franca

February 2017—NGS has taken its NBS, or next big step: a newly published joint consensus guideline on how to interpret and report sequence variants in cancer. With these 20 pages of best practices for making next-generation sequencing a regular part of cancer diagnostics, the field is moving, essentially, from frontier town to gated community.

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One bug or prix fixe? Respiratory pathogen testers weigh in

February 2017—With the number of rapid, accurate molecular assays for respiratory pathogens growing, microbiology laboratories have more options than ever. They include, among others, Meridian Bioscience’s Illumigene assays for group A Streptococcus and pertussis and its newest assay, Mycoplasma Direct, as well as Alere’s assays for influenza A/B, respiratory syncytial virus, and Streptococcus on its i molecular platform. No longer are laboratories limited to inaccurate rapid antigen tests, weeks-long culture, or multi-pathogen panels.

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AMP case report: An unusual BRAF mutation in a patient with melanoma, February 2017

February 2017—An activating BRAF mutation is found in 40 to 60 percent of melanoma patients. BRAF (B-Raf proto-oncogene) encodes a protein-kinase that activates the MAP kinase/ERK signaling pathway, a pathway that regulates cell differentiation, growth, and survival. Another protein, NRAS, normally activates BRAF. A mutated BRAF, however, can act independently of NRAS and skew cell activity toward growth and survival and away from differentiation.

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‘A marriage of virtual and real bronchoscopy’

February 2017—The molecular testing guidelines have been having a significant impact on surgical practices since they were issued, said thoracic surgeon Min Kim, MD, another webinar panelist. As practice at his institution, Houston Methodist Hospital, has evolved, Dr. Kim said, there has been an increasing need for minimally invasive ways of obtaining tissue from lung cancer patients.

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With metagenomic sequencing, no pathogen can hide

January 2017—Detecting pathogenic organisms with PCR has become a staple of the clinical microbiology laboratory, so much so that it seems like it has always been there. A more advanced molecular technique—unbiased metagenomic next-generation sequencing—will increasingly become a part of infectious disease diagnosis because it has several advantages over PCR. While it will be demanding to perform at first, it, too, may become a standard method in the clinical microbiology laboratory.

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Cytopathology In Focus: CAP meets MOC with à la carte modules online

January 2017—It’s the end of the year, say, and you are just a few self-assessment modules, or SAMs, short of the required 20 in your area of expertise—anatomic pathology. You have to meet the requirements for the American Board of Pathology’s Maintenance of Certification and time-limited cytopathology and AP/CP certificates for each two-year reporting cycle. What to do?

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The what and why of diagnostic management teams

January 2017—Michael Laposata, MD, PhD, has been speaking for years about the need for laboratory consultations and diagnostic management teams, and he will lead the first formal meeting Feb. 7–8 in Galveston, Tex., on what the teams are and how to implement them. Writer Ron Shinkman put a few questions to him about diagnostic management teams and pathology practice. Dr. Laposata is a professor in and chairman of the Department of Pathology, University of Texas Medical Branch-Galveston. Here’s what he said.

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Procalcitonin passes automation hurdle

December 2016—Matt Damon in Interstellar. Julia Roberts in The Player. Gene Hackman in Young Frankenstein. When movie stars appear in uncredited parts, it’s usually for a cameo, not a leading role. But in diagnostics, an uncredited or off-label use of an assay might be its main use—possibly even its most clinically important use.

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Highs, lows of immune checkpoint inhibitors

December 2016—Barry Nelson was the first in his cancer patient support group to undergo immunotherapy, which at the time was in a phase one clinical trial at Dana-Farber Cancer Institute. As the therapy became available to others in his group, they would ask for his advice on whether to try it. For the answer, he’d suggest they consult with their doctors and pray. He’d add, “I hope if you decide to go with it that you’ll have the same results that I do.”

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Lymphoid neoplasms: Steven Swerdlow on classification revisions

December 2016—In his CAP16 talk, “Lymphoma Diagnosis and Classification: My Search for the Holy Grail,” Steven H. Swerdlow, MD, acknowledged that the quest has been long and contentious and the resulting classification complex. Why, he asked, is lymphoma classification so complex? It reflects an explosion of knowledge about the immune system and lymphomas and an increasing number of therapeutic targets requiring increasingly precise diagnoses. In other words, it reflects the complexity of the disease itself. As oncologist Alan C. Aisenberg, MD, PhD, wrote in 1995, “The complexity of non-Hodgkin’s lymphoma reflects the complexity of the lymphoid system.”

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Is the value of hospital lab outreach underrated?

December 2016—Hospitals across the nation have been selling their laboratory outreach operations to national laboratories, which have been snapping them up from community hospitals and larger enterprises. Take Henry Mayo New-hall Hospital in California (LabCorp) and Hartford HealthCare in Connecticut (Quest Diagnostics) this year, for example, and MemorialCare in California (Quest) in 2015.

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Medicare revises 2017 discount on add-on codes: Increases professional, cuts technical, pay for prostate biopsies

December 2016—Overall Medicare reimbursement for some professional pathology services will rise in 2017 due to increases sought by the CAP for add-on codes and other services provided by pathologists to Medicare beneficiaries. At the same time, the Medicare program will move forward with cuts affecting the technical component of pathology services, including flow cytometry, due to a targeted revaluation mandated by federal law.

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New protocols on deck as pathology helps reshape cancer staging

December 2016—It’s a familiar campus lament. New editions of textbooks in some academic fields have become notorious for providing little more than a few extra paragraphs of text or a few more references and altered pagination—mainly, students suspect, to serve as a damper on the textbook resale market. What is happening with a key text in the field of cancer care, however, is in marked contrast. The changes contained in the 8th edition of the AJCC Cancer Staging Manual of the American Joint Committee on Cancer, slated to take effect Jan. 1, 2018, are the opposite of cosmetic.

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AMP case report: Isolated hepatic neuroendocrine tumor expressing albumin mRNA and arginase-1, December 2016

December 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Pittsburgh Medical Center.

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What molecular diagnostics laboratory systems offer

December 2016—As personalized and predictive medicine have progressed from not-in-my-lifetime to now available, health care information technology vendors have faced the challenge of how to manage a mass of molecular data and direct molecular testing processes. CAP TODAY asked vendors of molecular diagnostics lab information systems to explain what their products contribute to the flourishing field of molecular testing. Here are their responses.

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Recent approvals and the pipeline

December 2016—Pembrolizumab (Keytruda) is now FDA approved as monotherapy for patients with untreated metastatic NSCLC, both squamous and nonsquamous histologies, that express PD-L1 at a high level of 50 percent or more, says Dr. Roger Dansey, who headed up Keytruda development at Merck Research Laboratories. “We do not have data at this point that would say whether a cutpoint lower than 50 percent in the first-line setting would be of equal value in terms of response to Keytruda,” he says.

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Sequencing goes deep to find rubella in uveitis patient

November 2016—Metagenomic deep sequencing, or MDS, has scored another coup in the diagnosis of an unexplained disease in a patient who had already had extensive workup with all other available tools. MDS had been used in 2014 to detect unsuspected leptospirosis in a critically ill encephalitis patient, enabling appropriate treatment and full recovery. Now some of the same clinical scientists at the University of California San Francisco Medical Center who helped diagnose that patient have identified rubella virus infection in the eyes of a patient with bilateral chronic intraocular uveitis that had been misdiagnosed as idiopathic inflammation for 16 years.

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Big hopes, bigger questions with PD-L1

November 2016—Progress is a complicated minuet. One popular adage talks of “one step forward, two steps back,” which is not only discouraging but, in an even less-gleaming light, happens to be the title of one of Vladimir Lenin’s books, published in 1904. A more optimistic version (and one less centered on the crisis facing communists in turn-of-the-century Russia) suggests advances occur with two steps forward, mitigated by only one step back.

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AMP case report: Detection of cnLOH as a sole abnormality in the diagnosis of myelodysplastic syndrome, November 2016

November 2016—Copy neutral loss of heterozygosity (cnLOH) is an acquired abnormality found in patients with cancer and hematologic disorders and can be detected by molecular techniques such as PCR-based analyses and hybridization-based chromosome genomic array testing (CGAT). We report a case in which cnLOH was the sole abnormality detected by CGAT in a patient with myelodysplastic syndrome. This case illuminates the importance of utilizing CGAT results, namely cnLOH findings, as one of the primary diagnostic indicators in order to expedite initial therapies.

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In memoriam: Tyra T. Hutchens, MD | 1921–2016

November 2016—Tyra T. Hutchens, MD, who served as CAP president from 1977 to 1979, died Aug. 28 at age 94. Dr. Hutchens was CAP vice president from 1975 to 1977 and a member of the Board of Governors from 1968 to 1974. He was a member of the Executive; Standards; and Budget, Planning and Review committees and of the Council on Government Relations and Liaison and the CAP History Editorial Board.

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Shorts on Standards, 11/16

November 2016—The Laboratory Working Group of the National Kidney Disease Education Program and the IFCC Working Group for Standardization of Albumin in Urine are collaborating with IVD manufacturers to improve standardization of commercial measurement procedures. Urine albumin is an important biomarker for kidney damage.

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AMP case report: October 2016 test yourself answers

November 2016—In the October 2016 issue was a report, “Laser capture microdissection: Vanishing roles in tissue microdissection revalued in salvaging a melanoma with micrometastasis for BRAF V600E mutation detection,” written by members of the Association for Molecular Pathology. Here are answers (in bold) to the three “test yourself ” questions that followed that case report.

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Labs enter a MALDI-TOF state of mind

October 2016—When MALDI-TOF mass spectrometry enters the microbiology lab, it’s a little like watching Sir John Falstaff settle his considerable girth onstage. Things happen. Characters fret and flee, scheme, opine, panic, and, in the case of Prince Hal, ascend to greatness. (And, if we’re honest, some just get drunk.) Both, in brief, are an upending presence.

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Blood bank: On guard against daratumumab interference

October 2016—As fans of spycraft know, offensive counterintelligence can include an arsenal of strategies: initiating a diversion, sowing confusion, creating false identities—anything that makes another party believe something that isn’t true. If the cancer treatment drug daratumumab were capable of deceptive intent, it might be accused of all those ploys when it comes to interfering with blood transfusion crossmatching. The reason: For patients receiving daratumumab, marketed as Darzalex by Janssen Pharmaceuticals, antibody testing for transfusion is subject to erratic false-positives, often leaving transfusion services confused, uncertain, and on hold.

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Yale researchers dig for new kidney biomarkers

October 2016—An automated immunoassay has been created for symmetric dimethylarginine, or SDMA, a biomarker that can detect chronic kidney disease between 10 to 17 months earlier than creatinine, with 100 percent sensitivity and 91 percent specificity. And, unlike with creatinine, a patient’s muscle mass does not influence the biomarker’s reliability.

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AMP case report: Laser capture microdissection: Vanishing roles in tissue microdissection revalued in salvaging a melanoma with micrometastasis for BRAF V600E mutation detection, October 2016

October 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Florida College of Medicine, Jacksonville.

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CAP16: All-star team presented with CAP and Foundation awards

October 2016—Gene N. Herbek, MD, was presented Sept. 25 with the Pathologist of the Year award during the spotlight event at the CAP16 annual meeting in Las Vegas. At the same event, Cordelia E. Sever, MD, was given the Pathology Advancement award, Sang Wu, MD, the CAP Foundation Gene and Jean Herbek Humanitarian award, Carey Zimmerman August, MD, the Outstanding Communicator award, and Denise K. Driscoll, MS, MT(ASCP)SBB, the CAP Staff Outstanding Achievement award.

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When pain management testing calls for a consult

October 2016—Surprises might work for birthday parties—and even then they’re not everyone’s cup of tea—but not in drug screening programs. Perhaps the most common reason for doing a toxicology consultation is when a urine drug screen yields an unexpected result, either positive or negative, says Nicholas Heger, PhD, assistant director of clinical chemistry at Tufts Medical Center and assistant professor of anatomic and clinical pathology, Tufts University School of Medicine, Boston.

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Beauty fad’s ugly downside: test interference

September 2016—It’s the kind of health promotion advice one might pick up casually over lunch with friends, in a quick Google search, or during a visit to the hairdresser. Take megadoses of an over-the-counter vitamin called biotin—a common supplement in multivitamin compounds—and watch your skin improve and your hair and nails thicken and gleam. In recent years, online social networks and health-related websites have begun to teem with ads claiming that people have seen a transformation since they jumped on the biotin bandwagon.

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Mass spec up front for pain management testing: Interest growing in oral fluid testing as alternative to urine testing

September 2016—This fall, Brigham and Women’s Hospital, Boston, is taking the mass spec leap. A plucky PR person might be tempted to refer to it as MassSpec LEAP!™ but Stacy Melanson, MD, PhD, doesn’t have time for such nonsense. As the associate director of clinical laboratories and co-director of chemistry, Dr. Melanson has more important matters to attend to. She and her colleagues are shifting from using a screening immunoassay for pain management drug testing to up-front definitive testing by LC tandem mass spectrometry.

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Laboratory accreditation program 2016 checklists: Less legwork, more clarity seen in personnel changes

September 2016—For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. They are the leading source of disparities between the findings of the program’s inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. “Personnel is a hot topic for the College,” says CAP Checklists Committee chair William W. West, MD.

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New from CAP Press: Inspired by pathology, connected through art

September 2016—When Ray Paul was diagnosed with sarcoma in 2011, he wanted to understand his disease. His neighbor was a resident in the radiation department at Moffitt Cancer Center, Tampa, Fla., where Paul was being treated, and that neighbor was happy to introduce him to the pathologist on Paul’s case. An artist and biologist, Paul told the pathologist: “‘I want to see what my tumor looks like. I want to stare my devil in the eye,’” recalls Marilyn M. Bui, MD, PhD, a senior member of the Departments of Anatomic Pathology and Sarcoma, section head of bone and soft tissue pathology, and scientific director of the analytic microscopy core, Moffitt Cancer Center, and a professor and cytopathology fellowship director, University of South Florida Morsani College of Medicine.

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Quizzed in Ansbach, then key to a drug trial for mast cell disease

September 2016—In December 2007, American hematopathologist Tracy I. George, MD, spent a weekend in the small town of Ansbach in central Bavaria in the laboratory of Hans-Peter Horny, MD, whom she calls “the father of mast cell pathology.” Dr. Horny was at that time a privately practicing hematopathologist after having spent most of his career in academia. Plans for an international clinical trial were underway to evaluate the investigational drug midostaurin in advanced systemic mastocytosis, a rare group of diseases for which there was no effective therapy, and Dr. Horny would be the study pathologist. Dr. George, who had been diagnosing mast cell diseases for several years, wanted to take part as well.

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Method or test? Providing clarity to clinicians on NGS

September 2016—Whether it was “This is your brain on drugs,” “Take a bite out of crime,” or “Friends don’t let friends drive drunk” popping up onscreen, few of us watching TV in the 1970s and ’80s enjoyed having our programs interrupted by those public service announcements. Yet those important messages stuck in viewers’ brains—and stuck hard, if homages such as the Washington Post’s “10 Best PSAs of All Time” are anything to go by.

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Add-ons, consults spared cuts in proposed fee schedule: Dip in revenue, many technical component codes in for a hit

August 2016—The proposed Medicare physician fee schedule for 2017 features a slight dip in overall revenue for pathology groups and independent laboratories, but payment for flow cytometry and the technical components of prostate biopsy and surgical pathology work could fall by double-digit percentages if the Centers for Medicare and Medicaid Services stands pat with its final rule later this year.

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Painstaking process of drug monitoring

August 2016—As optimists like to point out (in their annoying way), showing up is half the battle. But it’s still only half, as other, equally clear-eyed folks might point out. That leaves plenty to do. And in drug testing for chronic pain management, the work facing laboratories may seem like even more than 50 percent.

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Cytopathology in Focus—Endoscopic ultrasound-guided FNA and core biopsy: Are we progressing to a best practice?

August 2016—Endoscopic ultrasound (EUS) is a safe and effective procedure for visualizing and screening for lesions within and in the vicinity of the upper gastrointestinal tract, liver, pancreas and peri-pancreatic lymph nodes, and soft tissues. In addition to the detection and imaging of these lesions, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) allows for concomitant sampling of visualized lesions for tissue diagnosis.

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ABP seeks volunteers to help shape next-generation MOC

August 2016—The American Board of Pathology has been selected to participate in the American Board of Medical Specialties’ Maintenance of Certification Assessment Initiative pilot. Currently, MOC Part III assesses a diplomate’s knowledge, judgment, and skills with a secure examination. The aim of the new initiative is to develop and test a new model for assessment that will be formative and summative.

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Cytopathology in Focus: The evolving management of LSIL in Pap tests

August 2016—The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses was developed to establish standardized terminology among pathologists for communicating to clinicians the findings of a Pap test.1 The Bethesda System has also facilitated the examination of the epidemiology and pathogenesis of cervical disease, with a focus on low-grade and high-grade squamous intraepithelial lesions (LSIL and HSIL, respectively) and their relationships to human papillomavirus infection and progression to invasive cervical carcinoma.

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In situ hybridization: more harmony across checklists

August 2016—As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. That is one reason members from three CAP committees started meeting to revise the ISH checklist, says CAP Surgical Pathology Committee member Aleodor Andea, MD, MBA. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines.

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A new case of severe hemophilia and Moyamoya (SHAM) syndrome

August 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Columbia University Medical Center. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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For certain thyroid lesions, the shift is on

July 2016—Time was running out for Yuri Nikiforov, MD, PhD, vice chair for molecular pathology and division director of molecular and genomic pathology, University of Pittsburgh Medical Center. For nearly a year he had been working to assemble an international group of experts—pathologists, endocrinologists, a surgeon, and, unusually, a psychiatrist and a patient advocate—to discuss that most vexing of thyroid tumors, encapsulated follicular variant of papillary thyroid carcinoma, or EFVPTC.

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Laboratory 2.0: Changing the conversation

July 2016—Bundled payments, physician employment, and unconventional competitors are cannibalizing the volume-based business model that for decades has defined laboratory medicine. And labs have little room within their customary confines—the three percent of health system spending they directly account for—to play a central role in American medicine’s transformation.

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In C. diff and cardiac care, lab steps up decision support

July 2016—What’s the one way to win friends and influence people? If you’re Eugenio H. Zabaleta, PhD, the answer is simple: Reduce the number of stool samples nurses have to collect. A few years ago, Dr. Zabaleta, clinical chemist at OhioHealth Mans-field Hospital, introduced a clinical testing algorithm for C. difficile that cut the number of stool samples by almost 50 percent. “And the nurses are loooving me for it,” he says happily. “The joke is, when nursing and lab work together, there is literally less crap for everybody.”

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A rare case of Diamond Blackfan anemia: identifying the causative mutation using NGS

July 2016—Diamond Blackfan anemia is a rare, inherited bone marrow failure syndrome manifesting as marked red cell aplasia and variable congenital anomalies. We report here a case of Diamond Blackfan anemia, which underscores the role of an integrated diagnostic workflow including hematopathologic evaluation and next-generation sequencing for establishing the diagnosis and potential management of rare, inherited bone marrow failure syndromes.

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In praise of the path less traveled: public health labs

July 2016—For those who crave variety in their work and have a penchant for the unusual, Paul Bachner, MD, has a career message: Don’t overlook public health. As medical director of the Division of Laboratory Services for Kentucky’s public health department from 2013 to July 2015, Dr. Bachner expected the unexpected, whether it was an outbreak of food contamination, a suspected case of Ebola, or a newborn with a life-threatening metabolic disorder.

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Poisoning, overdose: Better technology, workflow improve patient odds

July 2016—As pronouncements by fictional detectives go, one of the most famous is Sherlock Holmes’ declaration to Dr. Watson: “When you have excluded the impossible, whatever remains, however improbable, must be the truth.” Unfortunately, Holmes’ advice is no practical rule of thumb for solving the real-world mysteries of patient poisoning or overdose, because the possibilities are often so vast.

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Clampdowns on out-of-network billing climb

June 2016—To the average reader, “out-of-network billing” might seem like a technical concept that should mainly concern hyperaware insurance wonks. Media outlets from NBC News to Time to the Huffington Post have found that phrases like “surprise medical bill,” “angry patients,” and sometimes “sticker shock” in recent stories are much more likely to grab attention.

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Glucose PT criteria reset stirs standards debate

June 2016—It may not be an exact science, but resetting standards is a long-established means of improving quality of testing, and it can also be a way of adapting to improvements in quality that have already been realized. In the case of the CAP’s recent tightening of proficiency testing criteria for hospital glucose testing, both purposes are at work.

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All for one, one for all? Laboratory consolidation

June 2016—Consolidation among hospitals and laboratories can sometimes seem like too massive a tide for independent and hospital-based laboratories to effectively resist. What are the advantages that large size provides to a hospital system or national lab in a competitive marketplace? And will there be any space left in which smaller laboratories can survive?

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More clarity over time for heart failure biomarkers

June 2016—Robert Christenson, PhD, a professor of pathology and of medical and research technology at the University of Maryland School of Medicine, likens the U.S. mortality rate for myocardial infarction to three or four jumbo jets crashing daily. For heart failure, it’s about half that many deaths, “so maybe one and one-half jumbo jets,” Dr. Christenson said in a session on cardiac biomarkers at the CAP annual meeting last year.

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On a quest for the eureka moment in Zika virus testing

June 2016—The Zika virus testing challenges facing laboratories are many, including the virus’ low and short-term viremia and its resemblance to other flaviviruses, especially dengue and chikungunya. “These viruses present extremely similarly, and it’s very difficult to tell them apart based on clinical characteristics alone,” said Benjamin Pinsky, MD, PhD, who presented the details of diagnostic tests for Zika in an Association for Molecular Pathology webinar in April.

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Antiphospholipid Antibodies

June 2016—CAP Press has released the second edition of its 2008 book, An Algorithmic Approach to Hemostasis Testing, edited by Kandice Kottke-Marchant, MD, PhD. She is chair of the Robert J. Tomsich Pathology and Laboratory Medicine Institute and section head of hemostasis and thrombosis, Cleveland Clinic Foundation.

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SS18-SSX2 fusion transcript in the diagnosis of a poorly differentiated synovial sarcoma

June 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Penn State Milton S. Hershey Medical Center and Penn State College of Medicine. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

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Making a smooth pivot to point-of-care IQCP

May 2016—Practically speaking, there’s a limit to the number of balls a human can juggle. And there’s probably a limit to how complex a quality control plan a point-of-care testing coordinator can handle. Last year, many POC coordinators felt that the Centers for Medicare and Medicaid Services would be pushing that limit pretty hard with its new Individualized Quality Control Plan.

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Early days, early detection, early treatment for HIV

May 2016—In 1985, when the first test for HIV—then called human T-cell lymphotropic virus type III—became available, it was approved for screening blood products but not for diagnostic use. A diagnostic test for antibody to HIV-1 was soon approved. Over the subsequent 30-plus years, further iterations of HIV screening tests have been made, with increasing sensitivity and specificity and a shorter window to detection. Fifth-generation tests are now under review. CAP TODAY asked Eileen Burd, PhD, D(ABMM), to discuss the evolution of HIV diagnostics and algorithms for using them and to give a qualitative evaluation of the pending fifth-generation assay.

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Metastatic cancer of unknown primary: diagnostic challenges

May 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. Case report No. 11, which begins here, comes from Cooper Medical School at Rowan University and Cooper University Hospital, Camden, NJ.

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Heart biopsy the first step on a complex path

May 2016—The stories are haunting: a young, seemingly healthy athlete collapses on the playing field and dies. For Joseph Maleszewski, MD, section head of cardiovascular pathology, Mayo Clinic, Rochester, Minn., these deaths also seem sadly familiar, especially given his work with the NCAA on such cases. “Every community, it seems, has a story,” says Dr. Maleszewski, who is also associate professor, laboratory medicine and pathology, and associate professor, medicine. “A child died on the basketball court, on the football field, while running track. These young athlete deaths are not uncommon at all—or even young nonathlete deaths.”

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With high-sensitivity troponins, watching and waiting continue

May 2016—Laboratories and hospitals in the U.S. continue to look forward to high-sensitivity troponin assays. Judd E. Hollander, MD, says all he’s heard for the past five years is that an assay will be out at the end of the year. “And once you get halfway through the year, it will be out next year,” says Dr. Hollander, chair of the Department of Emergency Medicine and associate dean of strategic health initiatives at Sidney Kimmel Medical College of Thomas Jefferson University.

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FilmArray ME panel—clinical trial to 1st clinical test

May 2016—The BioFire FilmArray meningitis/encephalitis (ME) panel received FDA clearance last October, and in November Jennifer Dien Bard, PhD, D(ABMM), of Children’s Hospital Los Angeles, presented the results of the multicenter clinical evaluation of the panel, in a webinar produced by CAP TODAY in collaboration with BioFire. The panel’s use in the clinical setting will reduce turnaround time and may, pending further studies, have a positive impact on patient care and outcomes, said Dr. Dien Bard, director of the clinical microbiology and virology laboratories at Children’s Hospital LA.

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Cytopathology in Focus: Paris System: a new paradigm for urinary cytology

May 2016—The Paris System Working Group has proposed and published a standardized reporting system that redefines the primary purpose of urinary cytology: the detection of high-grade urothelial carcinoma (HGUC).1 A program to address standardization of urine cytology reporting was conceived at the 18th International Congress of Cytology in Paris in May 2013 where a number of people of like interest assembled and formed the Paris System Working Group.

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Cytopathology in Focus: Managing adults with thyroid nodules and cancer—2015 guideline highlights

May 2016—In January of this year, the American Thyroid Association published the 2015 update to its guidelines for the management of adults with thyroid nodules and differentiated thyroid cancer.1 Separate guidelines were published for the pediatric population in July 2015.2 Although the guidelines for adult patients were published as a “Special Article” in Thyroid, they run the length of a small book—133 pages in total.

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Cytopathology + More | Assessing needle core biopsy adequacy—survey of practices

May 2016—In the era of personalized medicine1 it is paramount to collect samples that will have sufficient material not only for an accurate diagnosis but also in many cases for prognostication or eligibility for targeted therapy or both. This may involve use of immunohistochemistry, flow cytometry, microbiological culture studies, and molecular studies. Fine needle aspiration and needle core biopsies (NCB) are used routinely for diagnosis of mass lesions from various sites in the body, and both FNA and/or cell blocks and NCB have been used successfully for these purposes.

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FilmArray GI: findings from first months of clinical use

April 2016—Treating Clostridium difficile can be dreadfully difficult, even when a clinician doesn’t have to navigate ordering restrictions based on testing frequency. So when Julie A. Ribes, MD, PhD, director of clinical microbiology at UK HealthCare in Lexington, Ky., received a phone call last year from a clinician who asked for repeat C. difficile testing, she was more than sympathetic.

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IQCP without agony at the point of care

April 2016—For many point-of-care testing coordinators, the prospect of developing Individualized Quality Control Plans is far from enticing. But there has never been much chance that laboratories could opt out of the Centers for Medicare and Medicaid Services’ new quality control framework for much of their nonwaived testing.

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Next-gen sequencing workflow in full spate

April 2016—With next-generation sequencing’s clear benefits—for diagnosis, prognosis, treatment, and trials—come its new challenges, and clinical laboratories are doing what it takes and sharing how. Two plenary speakers at last year’s meeting of the Association for Molecular Pathology spoke of variant calling in the bioinformatic pipeline and validation, and of clinical reporting. Colin Pritchard, MD, PhD, of the University of Washington and one of the speakers, sees reporting a genomic sequencing assay as more like making a histologic diagnosis, which he calls craftwork, than reporting a sodium value. “That’s an idea that hasn’t really permeated yet,” he said.

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Diagnosing polycythemia vera: conventional tools amid molecular options—case report and brief review

April 2016—Case. The patient presented in May 2013 at age 42 with a two-year history of fatigue and pruritus of his legs. He smoked one pack of cigarettes per day as he had for 25 years and had about five to six alcoholic drinks daily. Physical exam was unremarkable with no rash or palpable splenomegaly. Height was 74 inches and weight 189 pounds.

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Prostate pointers—PIN, ASAP, mimics, and markers

April 2016—Presenting on prostate cancer diagnosis at CAP ’15 last fall, David G. Bostwick, MD, MBA, recalled how he and Kenneth A. Iczkowski, MD, came up with the term “atypical small acinar proliferation suspicious for but not diagnostic of malignancy,” or ASAP, when they were at Mayo Clinic in 1997. They had scoured the Mayo files trying to spot the right term because they didn’t know what to call it, said Dr. Bostwick, who is medical director of Granger Diagnostics in Richmond, Va. “Should we call it suspicious but not diagnostic? Should we call it worrisome? Problematic?” Dr. Bostwick joked that his favorite expression seen in the files as a prostate biopsy finding in the 1980s was “semi-malignant,” saying, “I still don’t know what that means.”

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The challenge of intraductal carcinoma of prostate

April 2016—In his CAP ’15 presentation last fall, David Bostwick, MD, MBA, referred to intraductal carcinoma of the prostate as “sort of the rage right now in the urologic pathology field.” “The problem is that it has multiple different definitions, and interobserver agreement with it is moderate at best,” said Dr. Bostwick, medical director of Granger Diagnostics in Richmond, Va. Even when pathologists can agree on an IDC diagnosis, he said, they aren’t on the same page about treatment.

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In memoriam: Thomas P. Wood, MD | 1929–2016

April 2016—Thomas P. Wood, MD, the 25th president of the CAP, died Feb. 15 at age 87. Dr. Wood was speaker of the House of Delegates from 1992 to 1995, president-elect from 1995 to 1997, and president from 1997 to 1999. He was a longtime member of the Professional Affairs Committee (which he also chaired) and the Council on Government and Professional Affairs, and he was a board director of the CAP Foundation for six years. In 2000, the CAP recognized him as Pathologist of the Year.

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Immunotherapy steers focus to microenvironment

March 2016—It’s not every day that a monoclonal antibody leads the news. But when former president Jimmy Carter was successfully treated for metastasized melanoma last year with the new drug pembrolizumab (Keytruda), the story made headlines. Carter’s recovery—surprising to many when it was announced in December—may have been helped by traditional radiation and chemotherapy. However, the role played by pembrolizumab spotlighted immunotherapy as an exciting advance in the evolution of cancer treatment.

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Cutting cultures: the move to all molecular in virology

March 2016—For laboratories performing virology testing, taking advantage of molecular testing’s superiority to traditional testing methods is a no-brainer. But leaders in the University of Michigan’s clinical microbiology laboratory have found that the push to go all molecular for virology testing must be tempered by attentiveness to clinician preferences and a collaborative approach that’s likelier to make the journey a success.

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Lab shoots for better phlebotomy service, satisfied patients

March 2016—Try running a race and tying your shoes at the same time. That is the kind of challenge laboratories face when they endeavor to refine their processes while providing all the usual services clinicians and patients expect. When laboratory leaders at Brigham and Women’s Hospital in Boston surveyed the landscape of their phlebotomy operations, they spotted many opportunities for improvement through Lean Kaizen events as well as technology that reduces the risk of human error.

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Liquid biopsy—much to do about something

March 2016—Lynette Sholl, MD, isn’t fully sold on that hottest of feverishly hot topics, liquid biopsy. “It’s kind of a sexy colloquialism, I suppose,” says Dr. Sholl, associate director, Center for Advanced Molecular Diagnostics, and associate pathologist, Brigham and Women’s Hospital, Boston. “Is there an official definition?”

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Broadening the productivity spectrum with middleware

March 2016—As James Beck, MT(ASCP), remembers it, middleware was introduced at his institution about the same time that the nursing department decided connectivity should be the province of the laboratory. When the concept of docking and interfacing glucose testing devices came on the scene around the turn of the millennium, that was a turning point, says Beck, who is point-of-care testing coordinator for the University of Pittsburgh Medical Center–St. Margaret, which uses the Telcor middleware solution QML.

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Roads cross in clonal hematopoiesis and stem cell studies

March 2016—At the annual meeting of the Association for Molecular Pathology in November 2015, one plenary session was called “Exciting Times for Translational Research in Molecular Hematology.” In accord with the title, Margaret Goodell, PhD, gave an exciting talk about how hematopoietic stem cells are regulated in mice. While Dr. Goodell’s basic research was impressive, what was most remarkable was how it meshed with and anticipated research in human hematopoietic malignancies from other laboratories.

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PD-L1, other targeted therapies await more standardized IHC

February 2016—Immunohistochemistry is heading down a path toward more standardization, and that’s essential as it plays an increasing role in rapidly expanding immunotherapy, says David L. Rimm, MD, PhD, professor of pathology and of medicine (oncology) and director of translational pathology at Yale University School of Medicine. As a co-presenter of a webinar produced by CAP TODAY in collaboration with Horizon Diagnostics, titled “Immunohistochemistry Through the Lens of Companion Diagnostics” (http://j.mp/ihclens_webinar), he analyzes the core challenges of IHC’s adaptation to the needs of precision medicine: binary versus continuous IHC, measuring as opposed to counting or viewing by the pathologist, automation, and assay performance versus protein measurement.

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Bladder cancer preps for its star turn

February 2016—A streak of sibling rivalry emerges when experts ponder progress in the field of bladder cancer. Whether it’s new markers or therapies, funding or advocacy, advances have come slowly, and the disease has long labored in the shadow of others. “Urologic malignancies in general lag behind, compared to breast cancer and other tumor types, like colon and lung, where we’ve been envious for a while,” says George Netto, MD, professor of pathology, urology, and oncology and director of surgical pathology molecular diagnostics, Johns Hopkins University School of Medicine.

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Community hospitals keep time on tissue handling

February 2016—The great promise of genomics and actionable cancer biomarkers relies on cancer tissues being handled in the right way so they are suitable for study. Reducing cold ischemia time and the total time that biospecimens spend in formalin is key to the process, say guidelines from the CAP and the American Society of Clinical Oncology on HER2 and on estrogen receptor and progesterone receptor testing in breast cancer specimens.

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Non-melanocytic lesions—preventing pitfalls in diagnosis

February 2016—Musician Lauryn Hill has been quoted as saying, “Reality is easy. It’s deception that’s the hard work.” That viewpoint just might resonate with pathologists who sometimes have to diagnose deceiving-looking skin lesions. In a talk at CAP ’15, Deborah L. Cook, MD, professor of pathology and director of dermatopathology at the University of Vermont, shared several case examples that illustrate that investigative effort. All of them involve non-melanocytic malignancies known to mimic benign entities and the converse—“the proverbial wolf in sheep’s clothing” and “sheep in wolf’s clothing,” as she puts it.

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Rebooting IHC for companion diagnostics

January 2016—Immunotherapy has taken cancer treatment by storm. And given the number of proteins that are targets for immunotherapy and other targeted therapies, immunohistochemistry should theoretically be the ideal method for classifying patients as responders versus non-responders. But there are several reasons why IHC hasn’t reached this status within personalized medicine, says Clive R. Taylor, MD, DPhil, professor of pathology in the Keck School of Medicine of the University of Southern California.

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In next-gen sequencing, panel versus exome

January 2016—As next-generation sequencing takes its place in clinical laboratory medicine, a difference is developing between its use when there is a defined phenotype, as with hereditary oncology syndromes or hereditary cardiovascular disorders, and its use in diagnosing hereditary developmental disorders. In oncology, targeted panels remain the optimal mode of application.

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Nanotechnology in the clinical laboratory

January 2016—The CAP has 30 official liaisons to various organizations who attend scientific meetings or designate others to do so. They report to the Standards Committee, which reports to the Council on Scientific Affairs. We periodically publish bits of what the CAP’s outbound liaisons hear and see in their liaison roles.

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For infection control, PCR and culture compared
Plus, an in-house PCR test for HSV in CSF

January 2016—There is a reason why rigorous studies are done to prove even the seemingly apparent benefits of advanced techniques. Sometimes comparisons turn up unexpected findings, as demonstrated by two selected infectious disease abstracts about real-time PCR presented at the Nov. 5–7, 2015 meeting of the Association for Molecular Pathology. Even so, both abstracts show the value of PCR testing.

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Cytopathology + More | Anal cytology: life-saving potential at low cost

January 2016—Anal cancer incidence is on the rise in North America with rates of both invasive and in situ squamous carcinomas of the anus increasing sharply over the past several decades. While women have the highest overall likelihood of developing anal carcinomas, certain male subpopulations (namely men who have sex with men and those who are HIV positive) are at a dramatically increased risk of developing squamous precursors and carcinomas of the anal canal.

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For pathologists, 8% aggregate hike in Medicare pay

December 2015—The final Medicare physician fee schedule for 2016 delivered on the Centers for Medicare and Medicaid Services’ July proposal of an overall increase in payment for pathologists and independent laboratories. The agency also fulfilled some pathologists’ fears by cutting payments for prostate biopsy services by 19 percent for the technical component and 18 percent for the global payment.

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Prostate biopsy’s role in active surveillance

December 2015—As a treatment option, a strategy of active surveillance is becoming more widely accepted for early stage prostate cancer where risk of progression is low. But the new emphasis on active surveillance brings increased anxiety among prostate cancer patients about the information they’re getting from their physicians and how to deal with it. When M. Elizabeth H. Hammond, MD, participated four years ago in an open dialogue with prostate cancer patients at a conference on active surveillance, “I was really rocked by the things I heard,” she said. “The patients were angry and frustrated by our telling them active surveillance is a good treatment option.

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Latest HbA1c debate examines race as nonglycemic factor

December 2015—In 2010, the American Diabetes Association endorsed the use of hemoglobin A1c to diagnose type 2 diabetes, and fierce arguments over the wisdom of that move have ensued ever since. A 2013 debate at the American Association for Clinical Chemistry’s annual meeting featured a spirited dialogue on the merits of using HbA1c as a diagnostic marker, compared with the traditional—and still ADA-recommended—alternatives, fasting plasma glucose and two-hour plasma glucose.

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Guide to urinalysis instrumentation

December 2015—Not everyone shares Lauren Foohey’s idea of a good time, and she knows it. “Performing urine sediment analysis under a microscope—I thought it was fun,” Foohey says with a laugh. She spent 10 years in the laboratory before ultimately becoming senior director of global marketing for point-of-care urinalysis and diabetes at Siemens Healthcare, Point of Care Diagnostics.

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A step-by-step process to 95% autoverification

December 2015—Many laboratories have yet to reap the benefits of autoverification even though there is clear evidence of its benefits. During a recent internal study at Labsco, we discovered that more than 70 percent of our customers have not yet implemented AV. Of the customers who did perform AV, the highest percentage seen was about 60 percent (primarily in hematology and coagulation).

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Multiplex PCR test for detection of enteropathogens in an infant

December 2015—Clostridium difficile is an anaerobic spore-forming, Gram-positive bacteria transmitted by the fecal-oral route. The virulence of Clostridium difficile is primarily conferred from two toxins, A and B. Disruption of the normal gut flora, typically from intake of antimicrobials, allows Clostridium difficile to proliferate, causing a broad spectrum of clinical symptoms from asymptomatic colonization to colitis, a spectrum of diarrhea severity, and a protracted course of disease.

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3 new NGS Surveys on CAP 2016 PT launchpad

November 2015—More than two years ago, when the CAP decided to move forward with proficiency testing for next-generation sequencing, the decision point was modest. “We estimated that about 35 labs would subscribe, based on survey information, and that was sufficient for us to move forward,” says Karl V. Voelkerding, MD, chair of the CAP Next-Generation Sequencing project team.

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For proven natriuretic peptides, still much to be learned

November 2015—Natriuretic peptides could well be the Western canon of heart failure markers. The search for newer, perhaps more relevant, biomarkers continues, but BNP and NT-proBNP remain worthy of study. In their more classic roles, they are used to recognize heart failure as well as to stratify risk, where higher concentrations of either biomarker indicate a higher risk for complications, says cardiologist James Januzzi Jr., MD.

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Leveraging urinalysis for value-based health care

November 2015—Tim Skelton, MD, PhD, knows a fair amount about how to enhance the clinical value of urinalysis. It’s a subject that, as medical director of the core laboratory and laboratory informatics at Lahey Hospital and Medical Center in Burlington, Mass., he’s been focused on for the past three years. But he didn’t exactly set out to become an expert in that particular area. He was mainly trying to figure out why his laboratory was experiencing repeated urinalysis quality assurance failures.

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28 given awards for notable and longtime service

November 2015—Donald S. Karcher, MD, was presented Oct. 4 with the Pathologist of the Year award during the spotlight event at the CAP ’15 annual meeting in Nashville. At the same event, at the Gaylord Opryland, Rajesh C. Dash, MD, was given the Pathology Advancement award, and Latha Pisharodi, MD, received the CAP Foundation Gene and Jean Herbek Humanitarian award. Mary L. Paton, MT(ASCP), was given the CAP Staff Outstanding Achievement award.

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Mislabeling, wrong-blood-in-tube errors rare but there

November 2015—Blood is thicker than water, the saying goes. And thanks to a recent Q‑Probes, the rates of mislabeled specimens submitted for ABO blood typing and of wrong-blood-in-tube errors are now as clear as water. The mislabeling rate hasn’t changed much since a similar Q‑Probes study was performed in 2007. The 2015 Q‑Probes, “Blood Bank Safety Practices,” reviewed 41,333 specimens and found that 306, or 0.74 percent, were mislabeled. The previous study looked at 112,112 specimens, of which 1,258, or 1.12 percent, were mislabeled.

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Analyze this: data shines within and without

November 2015—At PAML patient service centers, patients fresh from a blood draw may spot a kiosk that asks, “How was your experience today?” Responding is as easy as pushing one of four buttons with facial expressions that range from a broad smile to a major frown. The kiosk’s manufacturer, HappyOrNot, says about 20 percent of customers across a spectrum of industries will stop to register their level of satisfaction.

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NY cuts labs loose from requirement to use state’s PT

October 2015—With the New Year approaching, many laboratories that test New York state specimens can look forward to breathing a sigh of relief. Regulatory relief, that is. Thanks to a policy change by the state’s Clinical Laboratory Evaluation Program (CLEP), beginning Jan. 1, 2016, laboratories will still have to be inspected by the state, but can fill New York’s proficiency requirement with the proficiency tests of any organization to which the CMS has granted deemed status under CLIA.

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Automated molecular platforms — the latest on two dozen

October 2015—CAP TODAY’s automated molecular platforms product guide begins on page 31 and features 26 platforms from 18 companies. Faster turnaround times and higher throughput are among the capabilities that manufacturers are touting. New to the market is BioMérieux’s EasyStream, which was first installed in Europe in 2014 and sold in the U.S. this year. EliTech Group, new to the product guide, introduced its Elite InGenius this year.

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Groups urge phase-in of RHD genotyping

October 2015—It may not be quite like boxing frogs or herding cats. But gaining broad consensus on a laboratory medicine practice can be difficult, especially where multiple organizations must agree. A new joint statement on RHD genotyping by the CAP and the AABB, plus four other organizations, shows that such consensus is possible, however, even where it involves a laboratory medicine practice in place for more than 50 years—especially when advances in molecular testing are offering a solution to a problem.

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For now, first still last in primary HPV testing

October 2015—Not long after the FDA approved a primary HPV screening algorithm for women age 25 and older, in April 2014, things began to stir on the Western front—specifically, in Bellingham, Wash., where Northwest Pathology is based. “We started offering it pretty much right after the FDA approved it,” says Ryan Fortna, MD, PhD, director of molecular pathology at the regional, independent anatomic pathology group.

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At the AACC Show 2015

September 2015—This year’s meeting of the American Association for Clinical Chemistry saw soaring temperatures in the host city of Atlanta and a lofty number of attendees. Nearly 18,000 laboratory professionals took part in the five-day extravaganza, which featured hundreds of educational sessions and poster presentations, along with 720 exhibitors that filled the expo floor. A selection of company news released at the meeting is included in this special section.

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Delta checks as safety net: how used, how useful?

September 2015—There was a time when Michael L. Talbert, MD, didn’t spend much time thinking about delta checks in his laboratory. “I would periodically look at them, but I didn’t put a whole lot of thought into ranges or into which analytes were most efficient or effective,” says Dr. Talbert, who is chair of pathology at the University of Oklahoma Health Sciences Center and chief of service and medical director of pathology and laboratory services at OU Medical System, Oklahoma City.

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In vivo microscopy checklist ready when labs are

September 2015—Why issue accreditation requirements for a technology before it’s seen widespread adoption? For the same reason you close the barn door before the horse has wandered out. At least that’s the view of Maria M. Shevchuk, MD, who, as chair of the CAP’s In Vivo Microscopy Committee, helped develop the new in vivo microscopy section of the Laboratory Accreditation Program’s 2015 anatomic pathology checklist.

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Unusual transplant-linked viral infections: ‘always be aware’

September 2015—Emerging and re-emerging viruses are well and alive, says Sherif Zaki, MD, PhD, chief of the Infectious Diseases Pathology Branch, Centers for Disease Control and Prevention. At the Clinical Virology Symposium in April, he spoke on viral etiology in unexpected deaths, presenting a list of outbreaks of unexplained illnesses in which his branch took part in the past two decades and which turned out to be caused by viruses.

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Trials show no benefit from fresher red cells

September 2015—Whether transfusion recipients are better off receiving fresher red blood cells has probably been the most pressing and controversial question in blood banking in the past several years. So much so that enormous randomized, prospective trials involving patients in the U.S., Canada, Europe, Australia, and Africa have been comparing outcomes from RBC units of different duration in a variety of patient subpopulations.

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Integrating AP and radiology, inch by inch

September 2015—Two major specialties serve all of health care as the foundation for diagnosis. Now efforts to align pathology and radiology again appear to be picking up steam. As payment shifts to so-called value-based care and as medical record systems may challenge successful test interpretation, many experts seek a clear integration of these two specialties.

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Pay is up in Medicare proposal, but final picture unknown

August 2015—After years of reading the latest news from the CMS with dread, pathologists and independent laboratories have some reason for revelry this summer as the agency’s proposed physician fee schedule offers an overall uptick in Medicare payment for 2016. Yet it is the final physician fee schedule, due in November, that will tell whether pathologists feel grateful toward the CMS when Thanksgiving rolls around.

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What’s new in next-gen sequencing checklist requirements

August 2015—The first CAP accreditation checklist requirements specific to next-generation sequencing were published only three years ago. “In 2012, those 18 accreditation requirements were basically all new language that the College’s Next-Generation Sequencing Project Team developed and submitted for review,” says project team chair Karl Voelkerding, MD, of the University of Utah Department of Pathology and ARUP Laboratories.

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Checklists 2015: signposts are clarity, consistency

August 2015—It doesn’t come swathed in a ribbon on the showroom floor, but the 2015 edition of the CAP Laboratory Accreditation Program checklists is new, improved in style and substance, and ready to roll. More precise and consistent quality terminology, more consolidation of requirements into the All Common checklist, and increased clarity on how labs can demonstrate their level of quality are among the highlights of the 2015 edition.

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Cytopathology + More | ICD-10: finishing touches or finding the road?

August 2015—To gear up for the change from ICD-9, the Centers for Medicare and Medicaid Services has provided updates and training and has kept ICD-9 changes to a minimum in an effort to build a strong crosswalk to ICD-10. Last year, the U.S. was given one more year to prepare, but that will not be the case this year. In fewer than 75 days, on Oct. 1, the U.S. will convert to ICD-10 coding.

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Laboratory automation: more than moving from here to there

August 2015—Move it, monitor it, manage it: Hardware and middleware, modules, and interfaces dominate the developments from at least five manufacturers of systems in this year’s product guide to laboratory automation systems and workcells—Beckman Coulter, Siemens, Sarstedt, Inpeco, and Cerner. The guide also includes four systems from a company new to the guide—IDS in Kumamoto, Japan—and additions from Aim Labs, Ortho-Clinical Diagnostics, Roche, and Beckman Coulter.

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Cytopathology + More | Telecytopathology’s potential starting to be seen

August 2015—There is a growing body of literature referencing the uses of telecytopathology in clinical care. Telecytopathology is the interpretation of cytopathology material at a distance using digital images. It can be subdivided into three basic applications: rapid on-site evaluation (ROSE), primary specimen diagnosis, and second opinion consultation. Although there is a long history of attempts at implementing telecytopathology for broad clinical use, it still has limited but important applications in patient care.

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Cytopathology + More | Primary HPV screening, Pap-HPV cotesting: interim guidance and a retrospective study

August 2015—The Food and Drug Administration in 2001 approved the use of high-risk HPV testing to triage ASCUS Pap test results (reflex testing). Two years later the FDA expanded the indications for hrHPV testing to include its use as an adjunct to cytology in women over age 30 (cotesting). The rationale for age 30 as a cotesting cutoff point was that hrHPV is common in sexually active young women and most infections are transient and clear without medical intervention.

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IOM report on diagnostic errors expected this fall

August 2015—The Institute of Medicine is expected to release in September a consensus study on diagnostic error in health care that will offer recommendations for policymakers, payers, medical institutions, physicians, and patients aimed at preventing harmful mistakes. This will come after nearly two years of studying the U.S. health system and reviewing the perspectives of stakeholders such as the CAP.

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Lab studies new steps in urine and anemia screening

August 2015—Despite the demonstrated value of implementing reflex testing algorithms to improve patient care and avert wasteful spending, the road from conceptual understanding to plan-in-action can be rocky. A pathologist at one academic medical center recently talked about his experience with reflex testing algorithms in the areas of urine screening and preoperative anemia screening. His story illustrates the barriers to change as well as the enviable outcomes that could potentially be achieved.

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Paths to validating next-gen sequencing assays

July 2015—As more clinical laboratories tread the unfamiliar ground of next-generation sequencing, they are faced with the age-old challenges of establishing validation and quality control processes. Two experts tackled the topic of molecular QC during a recent CAP TODAY webinar presented in cooperation with Horizon Diagnostics and available for viewing on demand ...

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For CKD, work is on to refine and find biomarkers

July 2015—Getting the upper hand on chronic kidney disease requires taking maximum advantageof existing CKD biomarker capabilities. It also means discovering new markers, though the trick is finding those that can expand treatment options. Some believe fibroblast growth factor-23 has the potential to fit that bill, with one researcher calling it “among the most exciting new targets in chronic kidney disease.”

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Business analytics insight within easy reach

July 2015—It used to be that business analytic solutions came only from LIS or enterprise-wide vendors, accessing these solutions meant going through the IT department, and laboratories’ requests to join the business analytics party frequently fell to the bottom of the priority pile. Forget “used to be.” Now, says Hal Weiner of Weiner Consulting Services LLC, in Eugene, Ore., “new tools have been developed by third-party vendors to make it much easier for labs themselves to create their own dashboards, their own queries, and their own monitoring tools.” And interest in business analytics is high among health care executives.

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In genetics, stay open to the unexpected

July 2015—When Uta Francke, MD, received the Association for Molecular Pathology Award for Excellence in Molecular Diagnostics at the 2014 AMP meeting, she titled her lecture “Adventures in Disease Gene Identification and Characterization of Mutations.” Her title was appropriate for a research clinician who, during her 35-year career, while working on several major human genetic disease challenges, contributed in significant ways to our understanding of important genetic disease mechanisms and whose laboratory identified the gene for Wiskott-Aldrich syndrome.

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Evidence drives guideline on reducing interpretive error

July 2015—Secondary review of surgical pathology cases is a common, if not universal, practice in U.S. anatomic pathology departments. The evidence has shown that case reviews detect errors. But until now, one important thing has been missing: consensus on the actual standard of practice for such reviews. Anatomic pathology departments have lacked evidence-based guidelines on how and when to conduct reviews.

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New lab, new efficiencies: doors open at Geisinger

July 2015—The last time Geisinger Medical Laboratories had a new facility, American women were still five years from getting the vote. Typhoid Mary had only recently ceased merrily showering her employers’ food with Salmonella enterica serovar Typhi. And the celebrity name on everyone’s lips was Charlie Chaplin. A view of the new laboratory building. “I think we have actually achieved the ideal in terms of efficiency,” says Dr. Schuerch (left), with Dr. Wilkerson.

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AKI risk biomarkers may be ‘as early as it gets’

June 2015—Last fall, the FDA cleared Astute Medical’s NephroCheck to pinpoint critically ill adults likely to manifest moderate to severe acute kidney injury within 12 hours. The urine biomarker test’s investigators believe NephroCheck will give clinicians the early warning signs they need to head off impending cases of AKI, though it remains to be seen whether that hoped-for prevention will bear out in clinical outcomes studies. One important laboratory hurdle to widespread use of the test is that it is performed on a countertop instrument separate from the automated line used for all other urinalyses.

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RFID keeps lab’s supplies on hand, just in time

June 2015—Sharon Cox, MT(ASCP)SM, has a passion for the correct count. Charged with managing the laboratory supply inventory as core lab supervisor at Saint Francis Health System in Tulsa, Okla., she knows the right tally matters. Get it wrong and the lab can wind up with too little of what is needed. That can mean big overnight shipping charges when things run out unexpectedly. To avoid that outcome, the lab may order more supply than necessary, which leads to a different kind of problem.

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For viral diagnosis, metagenomic NGS

June 2015—A 20-year-old woman who had returned to the U.S. after two months of hiking in Western Australia presented with three days of acute febrile illness—fever, rash, headache, nausea, and muscle and joint pain. Testing for common infectious causes of acute febrile illness, including Epstein-Barr virus, cytomegalovirus, and human immunodeficiency virus, all turned up negative. While the woman was in Australia, she had been warned about an ongoing outbreak of an exotic alphavirus, Ross River virus, in the region where she was hiking.

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New guideline spells out IPMN essentials

June 2015—It was a call he dreaded making. It was the late 1990s. Volkan Adsay, MD, was following up on a former patient who had been diagnosed eight years earlier with pancreatic cancer, one related to an intraductal papillary mucinous neoplasm. The patient’s medical record noted that despite chemotherapy, the prognosis was grim.

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Pharma strives to aid companion diagnostics

May 2015—M. Elizabeth H. Hammond, MD, is no mind reader. But approach her at a conference or meeting, and she has a pretty good idea what you’re going to ask her. “I was the chair for the 2007 and 2013 ASCO-CAP HER2 guideline, and since that time, the most common question I get from individuals is, ‘How do you know the guideline is making any difference?’” says Dr. Hammond, who is a professor of pathology and adjunct professor of internal medicine at the University of Utah School of Medicine and a consulting pathologist, Intermountain Healthcare.

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MALDI in microbiology: Set to stun?

May 2015—In the business world, the term “disruptive innovation” is hot. In product launches, business plans, and job resumes, it’s become a standard part of the pitch. Like the flux capacitor in the fictional DeLorean time machine, disruptive innovations vault a field past traditional barriers and obstacles, outstripping rival technologies.

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At CAP ’15, 98 courses and a focus on daily practice

May 2015—With several dozen pathology associations worldwide, many with their own meetings, why should a pathologist opt to attend CAP ’15 in Nashville, Tenn., Oct. 4–7? Philip Cagle, MD, supplies some thoughts. “There are many pathology organizations, and each has its own niche. Whereas at the CAP meeting, there are many courses covering a broad range of areas, from things such as practice management and quality assurance to different areas of anatomic pathology and clinical pathology,” says Dr. Cagle, ...

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Aptima HPV and Aptima genotype assays for triage of borderline squamous (ASCUS) cytology: CLEAR study

May 2015—The characterization of the HPV genome and development of techniques that have the ability to detect nucleic acids in cytologic specimens has had a major impact on patient management. The Hybrid Capture 2 High-Risk HPV DNA Test, or HC2 (Qiagen, Gaithersburg, Md.), which uses probes designed to target the entire HPV genome, was cleared by the FDA in 1996. It was soon realized that determination of clinical sensitivity and specificity was essential to fully characterize assay performance and understand and classify correlation with cervical disease.

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Labs solve price, space squeeze to welcome TLA

May 2015—After several years of watching their European counterparts have all the fun, a handful of American microbiology laboratories are going live with systems touted as providing total automation of diagnostic bacteriology. The systems automate how specimens are barcoded, plated, and inoculated, then move the plates on a track to an incubator, photograph them at a preset incubation time, discard or keep the plates as appropriate, and offer up the digital images for interpretation by medical technologists viewing them on computer screens.

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Cytopathology + More | Latest guidelines for pancreatobiliary cytology—a recap

May 2015—Pancreatobiliary malignancy currently accounts for about three percent of all cancer cases and six to seven percent of all cancer deaths, making it the fourth leading cause of death in the U.S. Between 2006 and 2010 the incidence rate of pancreatic cancer increased by 1.3 percent per year and the death rate increased by 0.4 percent per year.1 The incidence of pancreatic cancer has tripled since the 1920s, likely secondary to an aging population, improved disease reporting, and possibly due to increased environmental mutagens2 such as smoking.

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Cytopathology and More | Negative Pap, positive hrHPV: what we know so far

May 2015—Cervical cancer is the second most common cancer in women worldwide, and high-risk human papillomavirus (hrHPV) is considered the principal causative factor in the development of most cervical cancer and its precursor lesions. For this reason, screening algorithms that include testing for hrHPV are part of the new cervical cancer screening guidelines set forth by the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology.

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Cytopathology and More | Inside the 2014 Bethesda System for Reporting Cervical Cytology

May 2015—The value of standardized terminology for reporting cytology and histopathologyhas been essential in our work and important for patient care. The Bethesda System for Reporting Cervical Cytology, put forward in 1988 thanks to the pioneering work of Diane Solomon, MD, and Robert Kurman, MD,1 saw unprecedented adoption around the world. The Bethesda System, or TBS, led to a number of significant downstream events ...

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Pressing questions in POC glucose testing

April 2015—Sometimes major changes to a health care organization’s point-of-care testing system come from powerful regulatory agencies in Washington, DC. Or they may arise when a child with diabetes objects to frequent venipuncture. In either kind of case, experts say, pathologists and laboratory professionals must form strong relationships with clinicians and build structural foundations to help them meet these and other demands.

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Nothing peripheral about assessing the ‘other’ cytopenias

April 2015—Think age is important only if you’re a Hollywood actress (unless you’re lucky enough to be Meryl Streep)? Think again. Specifically, Joan Etzell, MD, wants pathologists to think about age-adjusted reference ranges for thrombocytopenia and neutropenia. They’re intrinsic to the basic definitions of these diseases, she pointed out in a course on peripheral cytopenias at last year’s AACC meeting.

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Workflow, regulatory unknowns tax molecular IT

April 2015—Alexis Carter, MD, immediate past president of the Association for Pathology Informatics, isn’t under any illusion about how well information technology is meeting the needs of molecular diagnostics. “Laboratory information systems right now do a fairly decent job of getting samples to the right lab, tracking the sample, and reporting results,” Dr. Carter says. But when it comes to molecular diagnostics laboratories, “LISs are really not where they should be. They’re kind of moving at a turtle’s pace to keep up.”

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At St. Jude, preemptive PGx tests guide prescribing

April 2015—St. Jude Children’s Research Hospital, Memphis, brings a razor-sharp focus to its mission: the 78-bed institution cares for children with catastrophic illnesses, including leukemias and lymphomas, solid tumors, hematology disorders (including sickle cell disease), and infectious diseases. It doesn’t have an emergency department. Consistent with its goal of advancing cures, all its patients are enrolled in research protocols.

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Groups closing the gap in reference materials for sequencing assays

March 2015—It’s a truism in the clinical laboratory that your results are only as good as the reference standards available to QC your assay. For measuring small analytes like glucose that’s not a problem. However, in clinical laboratories the analyte in question increasingly is DNA. In the past five years, next-generation sequencing has been adopted to detect variants in small targeted regions of specific genes, which is useful in oncology and medical genetics. More ambitious applications of NGS—whole genome and whole exome sequencing—have recently begun to enter the clinical realm as well.

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Genetic profiling vies with IHC in retune of CUP testing

March 2015—Tesla beats Camry. Online catalogs replace paper. Keurig edges out Chemex. Mobile trounces landline. When paradigms shift, the theory goes, we can only cling to the technology in the outbox for just so long. But that’s a theory that may not apply to diagnostic testing for cancer of unknown primary (CUP). Microarray-based gene expression profiling (GEP) has recently gained a foothold in the quest to identify origins and therapeutic targets for metastatic cancer, but traditional immunohistochemistry is not about to be sidelined.

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With molecular MPN testing, think positive

March 2015—If molecular tests for myeloproliferative neoplasms ever decide to write their autobiography, they could easily do a riff on the business bestseller Getting to Yes. For myeloproliferative neoplasms, morphologic and clinical findings should guide molecular analysis, which can often be a helpful way to clinch the diagnosis, says Dr. David Czuchlewski (left), of TriCore Reference Laboratories, with Mohammad Vasef, MD, TriCore’s director of molecular diagnostics.

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Paths to validating, using urine sediment analyzers

March 2015—Before Lahey Hospital and Medical Center’s clinical laboratory brought an automated urine sediment analyzer on board last November, it had been doing manual microscopy on positive dipstick specimens only. A review of that practice uncovered problems with quality, including patient misdiagnosis, says Tim Skelton, MD, PhD, medical director of the core laboratory and laboratory informatics at the tertiary care medical center in Burlington, Mass.

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Hear me now? Another audition for speech recognition

March 2015—When Pete Fisher, MD, says his name aloud, the speech-recognition system he uses spits out the words “deep fissure” on the screen. And there are times when he says “note that” and “note fat” pops up instead. Despite the occasional hiccups, he loves the software and the freedom it affords him to do his work without being bound to a transcriptionist’s timetable.

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From the bench, a view of MALDI-TOF mass spec

February 2015—Melissa Jones, MT(ASCP), doesn’t mince words—not when it comes to MALDI-TOF MS. “It’s going to revolutionize the way you do microbiology in your laboratory, and you’re absolutely going to love it,” said Jones, who is a microbiology specialist for clinical microbiology and immunology at McLendon Clinical Laboratories at University of North Carolina Hospitals, Chapel Hill.

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Trials for errors: how one lab fixed reporting flaws

February 2015—Cincinnati Children’s Hospital Medical Center has all but eliminated errors in laboratory test reporting thanks to a project performed through the Intermediate Improvement Science Series, a nationally accredited course offered by the medical center’s James M. Anderson Center for Health Systems Excellence to leaders from Cincinnati Children’s and other health care systems.

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Interface validation: abort, retry, succeed

February 2015—When you go looking for problems, you’re bound to find them. That truism is especially pertinent in the arena of interface validation, as the team at New York’s North Shore-LIJ Health System discovered recently. The laboratory professionals there were charged with helping to implement the first phase of a joint venture with New York City’s Health and Hospitals Corp. (HHC), in which North Shore-LIJ would serve as the massive public health system’s primary reference lab.

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Makeovers smarten core labs’ quality control

February 2015—In speaking to audiences all over the world about the intricacies of risk management through quality control, QC expert Curtis Parvin, PhD, has noticed a certain pattern over the past 10 years. Following his presentation, he’s likely to hear this reaction: “I’m not sure I totally understand that. It sounds pretty impressive, but how do you expect me to go through that process in my lab?”

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The inside track in AP automation: new product guide

February 2015—Tissue processors, tissue embedders, microtomes, slide stainers—we tackled them all in our first-ever product guide to anatomic pathology automation. (Yes, we realize most tissue embedders are largely manual but included them because they are vital to the automated process.) Zeroing in on what questions to ask the vendors—that is, knowing what you, the readers, need to know—was no simple task.

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Diagnostic perils of hematologic illness

February 2015—Like a modern-day Pericles, Tracy George, MD, had much to traverse in her overview of leukocytosis, thrombocytosis, and erythrocytosis during a course on diagnostic hematology at last year’s AACC meeting. Unlike Shakespeare’s Pericles, however, Dr. George navigated the many twists of her topic with the efficiency and near-encyclopedic knowledge of an experienced tour guide.

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Liver donor organ evaluation

February 2015—CAP Press’ new Atlas of Transplant Pathology is now out. We spoke with its editors and a contributor last month; this month we bring to you one of its 56 chapters. To order, see next page. Protocols for histologic evaluation of potential donor livers for steatosis and other pathology vary by center.

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Cytopathology and More | Automated screening workload limits are too high

January 2015—A task force of the American Society of Cytopathology in 2009 began the work involved in developing workload recommendations for cytotechnologists who screen image-guided Pap tests. The available data strongly suggested that Pap test screening workloads, as currently approved by the FDA and practiced in some laboratories, are too high and may represent a patient safety risk for the women whose Pap tests are reviewed under those conditions.

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Anatomic pathology ‘practitioner’? Emerging roles for the cytotechnologist

January 2015—As new technology is incorporated into practice and health care reimbursement models evolve, the field of pathology continues to transform. For example, in gynecologic cytopathology, Papanicolaou testing is declining as molecular testing for human papillomavirus is incorporated into cervical cancer screening. This has an adverse impact on daily cytotechnology workload. Simultaneously, decreased reimbursement is affecting pathology practices, and questions have been raised about potential shortfalls in the future pathologist workforce.

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Medical genetics labs shine in 10-year proficiency test data

January 2015—Molecular genetics laboratories in the U.S. are doing a great job. Ten-year data from the molecular genetics Surveys in the CAP proficiency testing program show that U.S. clinical laboratories are making extremely accurate calls using molecular genetics assays. At the 2014 meeting of the Association for Molecular Pathology, Karen E. Weck, MD, and Iris Schrijver, MD, presented results from seven of the proficiency Surveys that the CAP/ACMG Biochemical and Molecular Genetics Resource Committee oversees. Dr. Weck is the chair of the committee; Dr. Schrijver is past chair.

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Coagulation analyzers: Recently released and soon to be seen

January 2015—CAP TODAY’s 2015 guide to coagulation analyzers begins here. Diagnostica Stago last year released rivaroxaban and apixaban calibrators and controls (research-use only) for automated anti-Xa activity assessment. It expects in the coming months to submit them for 510(k) clearance, says Nichole Howard, Stago’s communications specialist. The company will soon release the automated ecarin chromogenic assay for dabigatran (RUO).

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LIS to EHR: Is results transmission what it should be?

January 2015—While no one would question the virtues of accurate laboratory results, a recently concluded Q-Probes study is a new reminder that alone they’re not enough. Results should be reviewed before a lab goes live with a new interface that transmits results to the electronic health record, as well as when changes are made at the laboratory or EHR level that could alter test resulting. They also should be reviewed periodically, say the authors of the study, titled “Validating Laboratory Results in Electronic Health Records.”

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Cytopathology + More | For cytopathologists, MOC exam pass rates and options in 2014

January 2015—Last year was the first year that the American Board of Pathology offered Maintenance of Certification Part III subspecialty examinations. Sixty-four diplomates took a pilot exam in 2013, but it included only anatomic pathology and clinical pathology modules. The secure examination may be taken in years seven to 10 after enrollment in MOC, with no more than 12 years elapsing between examinations. All 2014 examinations were given in Tampa, Fla., but there are plans to offer testing in other locations in the future.

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