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ALL ISSUES

From the President’s Desk: Let’s close the knowledge gap, 8/16

August 2016—Most of us have heard the laboratory described as a black box where specimens are exchanged for information and diagnoses. This tells me that we work beside some highly skilled people who don’t know what we do and that the knowledge gap makes them uncomfortable enough to joke about it. This incomplete understanding of what takes place within the laboratory has meaningful consequences in multiple contexts.

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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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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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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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Clinical Pathology Abstracts, 8/16

August 2016—Cold antibodies may be detected with routine pretransfusion testing and may obscure the identification of clinically significant red blood cell antibodies. They may be detected in healthy people or may be transient in appearance after a mycoplasma or mononucleosis infection. In most cases, cold antibodies are benign, and pretransfusion laboratory testing is designed to avoid detecting these antibodies by eliminating testing at room temperature.

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Anatomic Pathology Abstracts, 8/16

August 2016—Use of HSP70 and glutamine synthetase to diagnose hepatocellular carcinoma; Recurrence of benign and low-grade fibroepithelial neoplasms of the breast; Lobular neoplasia detected in MRI-guided core biopsy: a high risk for upgrade; Use of microsatellite instability, MLH1 methylation analysis, IHC to identify Lynch syndrome; Differential diagnosis of bladder versus colorectal adenocarcinoma; Enhanced expression of PD L1 in CIN and cervical cancers

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Molecular Pathology Selected Abstracts, 8/16

August 2016—Germline mutations in men with metastatic prostate cancer: Prostate cancer displays great diversity in clinical behavior, ranging from essentially silent, organ-confined disease to rapid and aggressive metastatic spread. The authors know of no clear-cut screening method that can reliably identify those patients whose tumors are likely to behave aggressively and, therefore, may benefit from a more active treatment strategy. Prostate cancer has also been shown to have a significant component of heritability.

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Q&A column, 8/16

August 2016—If you obtain a platelet count from a blood sample collected in a sodium citrate tube, the result is multiplied by 1.1 to correct for the volumetric difference in anticoagulant compared with EDTA. When you result the platelet count from the sodium citrate tube, is it a CAP requirement to attach a comment such as: “_#__ Results reported from blue top tube. The reference range and other method performance specifications have not been established or approved by FDA. Use results with caution.”

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Put It on the Board, 8/16

August 2016—LabCorp will acquire Sequenom; New York ends state PT services; St. Jude lands CAP ISO 15189 accreditation; Epigenomics’ DNA test included in CRC guideline; OSU to deploy Inspirata digital pathology solution; Mindray’s clinical chemistry analyzer cleared; Successful Keytruda trial stopped early; Top court clarifies autopsy’s place in Texas law; EUA for Siemens Zika assay

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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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Shorts on Standards: Update on the frontier of NGS, 7/16

July 2016—Next-generation sequencing has continued to deliver on its promises and potential in the diagnostic arena. However, as with any emerging and evolving technology, the medical and scientific community faces the challenge of assessing the implications and demonstrating definitive clinical uses of its expanding capabilities, especially in the context of medical efficacy, clinical utility, and cost efficiency.

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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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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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Clinical Pathology Abstracts, 7/16

July 2016—Utilization management to reduce unnecessary lab testing at a VA hospital: It is estimated that laboratory and pathology testing account for four percent of annual health care costs. A laboratory utilization management system, or laboratory expert system (LES), can be employed to reduce such costs. A variety of functionality, including passive and active alerts, in the computerized physician order entry (CPOE) system provide decision-making support for physicians ordering tests.

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Molecular Pathology Selected Abstracts, 7/16

July 2016—Using single nucleotide polymorphism arrays in acute lymphoblastic leukemia: In patients with acute lymphoblastic leukemia/lymphoma, the identification of chromosomal abnormalities at the time of diagnosis is important for risk classification. The current standard of care includes karyotype and FISH analysis to identify recurrent cytogenetic abnormalities.

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Newsbytes, 7/16

July 2016—How to minimize cybersecurity risks from business associates: Like parents, through the decades, telling their teenagers, “It isn’t all about you,” cybersecurity firms are sending health care organizations a similar message: It isn’t all about you—it’s about your business associates too.

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Q&A column, 7/16

July 2016—What are the steps to validating maximum dilution for certain analytes when the stated manufacturer dilution is not enough? What is considered best practice for verifying platelet-poor plasma for coagulation? Is it necessary to measure platelet counts from 2.7 mL and 1.8 mL tubes? Is annual verification consistent with best practice?

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Put It on the Board, 7/16

July 2016—Michel: The good, bad, and ugly that labs need to know: Robert Michel’s opening remarks at the Executive War College, which can be seen as a kind of state of the union address for laboratory medicine, focused on the trends in the industry and the opportunities and dangers they create. “Fraud and abuse. That’s the ugly,” Michel began. “Folks who are doing lab medicine the right way aren’t really aware of what’s been happening outside the walls of their laboratories.”

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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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From the President’s Desk: CAP16: All in one place, 6/16

June 2016—Even though I had a good idea of what would be in the CAP16 program, my heart raced when the final curriculum arrived. Perhaps because of my role as CAP president, I found myself taking a slightly different perspective than in the past and thinking about just how ambitious an undertaking it is. A program this complex involves serious choreography. Those who construct it must be thoughtful, forward-looking, and sensitive to many compelling needs and interests competing for limited time and space. It’s a big job.

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In memoriam: Raymond C. Zastrow, MD | 1930–2016

June 2016—Raymond C. Zastrow, MD, the 24th president of the CAP, died April 28 at age 85 following complications of surgery. A member of the CAP Board of Governors from 1985 to 1988, Dr. Zastrow also served as CAP secretary-treasurer from 1988 to 1993, president-elect from 1993 to 1995, and president from 1995 to 1997. In 1998, the CAP recognized him as Pathologist of the Year.

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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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Clinical Pathology Abstracts, 6/16

June 2016—Fasting or nonfasting lipid measurements: The joint American College of Cardiology and American Heart Association “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults” replaces low-density lipoprotein cholesterol treatment thresholds with a more global measurement of risk.

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Q&A column, 6/16

June 2016—Can you offer feedback on the growing trend of using type A fresh frozen plasma in emergencies instead of type AB? Is this being used mainly in trauma hospitals and military sites or is the trend becoming more popular in smaller hospitals too?

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Put It on the Board, 6/16

June 2016—Guidance seen as sign of FDA openness to digital pathology, Eco effort cuts biohazard waste, saves money, EGFR mutation liquid biopsy OK’d as companion Dx, Qiagen adds Horizon QC to next-generation system, Siemens enters molecular oncology services market, Roche PD-L1 tabbed as complementary test

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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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Clinical Pathology Abstracts, 5/16

May 2016—Platelet transfusion: a clinical practice guideline from the AABB: The AABB recently developed guidelines on the appropriate use of platelet transfusions in adults. The guidelines are based on a systematic review of randomized clinical trials and observational studies from 1900 to September 2014 that reported clinical outcomes on patients who received either prophylactic or therapeutic platelet transfusions.

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Anatomic Pathology Abstracts, 5/16

May 2016—Noninfectious aortitis of the ascending aorta: a histological and clinical correlation of cases; Stratifying HPV-induced cervical pathology using E4 with p16 or MCM; Limited resection versus lobectomy for older patients with early-stage lung cancer; L1CAM expression and its association with mutant p53 expression in endometrial cancer; Value of p16 staining for predicting outcome of LSIL/CIN1

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Q&A column, 5/16

May 2016—What laboratory test should be used to monitor the effect of the heart failure medication Entresto (sacubitril/valsartan)? After getting a consultation report, I usually issue an addendum without changing my own diagnosis. Some of my colleagues use an amended report with their own diagnosis changed. They say this will help clinicians with patient management. I do not feel confident about many of these difficult cases, so I do not want to change my diagnosis. We would like to establish a department policy to address this. Can you provide guidance?

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Newsbytes, 5/16

May 2016—Sunquest acquires GeneInsight; Technidata launches lab system; HHS seeks feedback on measuring growth of interoperability in health IT; Xifin upgrades collaboration and clinical data-management platform; Kalorama Information releases report on global LIS market; Aspyra announces LIS installation

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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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From the President’s Desk: Our role in population health, 4/16

April 2016—In late January, I represented the CAP at MEDLAB, the medical laboratory conference and exhibition held each year in Dubai, United Arab Emirates. MEDLAB was held in conjunction with Arab Health, a multidisciplinary conference attended by more than 130,000 people from 163 countries. I was asked to present six separate talks in Dubai; the one on precision medicine in pathology drew more than 1,200 attendees.

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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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Anatomic Pathology Abstracts, 4/16

April 2016—Comparison of methods for analyzing gene amplification in gastric cancers; Uterine smooth muscle tumor analysis by comparative genomic hybridization; Role of TAZ in aggressive types of endometrial cancer; Reclassification of resected lung carcinomas diagnosed as squamous cell carcinoma; Sequencing of cancer genes in ampullary carcinoma shows trends in histologic subtypes; Prognostic significance of the 2014 ISUP grading system for prostate cancer

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Q&A column, 4/16

April 2016—We review peripheral blood smears and sometimes provide recommendations. For microcytic anemia with high red blood cell count, iron study and hemoglobin electrophoresis are suggested to rule out hemoglobinopathy. But for cases of microcytosis with high RBC count but without anemia, should we give the same recommendation as for an anemic patient?

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Newsbytes, 4/16

April 2016—Finding, fixing, and foiling shadow IT problems: The unsanctioned use of mobile devices and cloud-based software in the workplace, often referred to as shadow IT, is a pervasive problem. Yet, through education and enforcement of policies, it’s a problem that can be minimized.

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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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Put It on the Board, 4/16

April 2016—Logistics hurdles overcome for single Pap-HPV report: Is one test better than two? That question—primary HPV versus the Pap-HPV cotesting option—has roiled the world of cervical cancer screening since the Food and Drug Administration approved a primary HPV screening test in April 2014. However clinicians decide to answer that question, this much is clear: A single report is better than two separate results.

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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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Anatomic Pathology Abstracts, 3/16

March 2016—Reproducibility of residual cancer burden for assessing breast cancer after neoadjuvant chemotherapy: The residual cancer burden index was developed to quantify residual disease ranging from pathological complete response to extensive residual disease. The authors conducted a study to evaluate inter-pathologist reproducibility in the residual cancer burden index score and category and in their long-term prognostic utility.

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Molecular Pathology Selected Abstracts, 3/16

March 2016—Enhancing tumor selectivity of a picornavirus virotherapy: Oncolytic viruses that selectively target tumor cells are a promising cancer therapy and are thought to work not only via direct lysis and destruction of tumor cells but also through recruitment and activation of the host’s anti-tumor immune response. While there are a number of naturally occurring viruses that preferentially replicate in cancer cells and have otherwise limited effects in human tissue, the real therapeutic promise lies in genetically engineered viruses.

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Clinical Pathology Abstracts, 3/16

March 2016—Impact of add-on laboratory testing at an academic medical center: Clinical laboratories are often asked to perform additional laboratory tests after the original sample is received and testing per the original order is complete. It is well known that this significantly increases laboratory workload and impacts turnaround time.

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Q&A column, 3/16

March 2016—I have a question regarding auto-verification delta checks, not for a single patient but between all patients tested during a given period. Are there labs that use postanalytic comparisons of clinical lab results during the testing interval between quality assurance checks to ascertain if the autoverified results being released are reasonable?

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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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Newsbytes, 3/16

March 2016—Digital consults: options for getting from here to there: The U.S. digital pathology consultation marketplace is steadily gaining ground, largely owing to increased demand for international consultations. And those delving into digital consults are making a three-pronged decision: build your own system, install an off-the-shelf software solution, or sign up with a Web-based digital consultation network.

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Put It on the Board, 3/16

March 2016—Case raises uncertainty on autopsy’s legal status: Should a hospital-provided autopsy be considered health care? It’s a question the Supreme Court of Texas will decide this spring, and its answer to that question will make a big difference—in the millions of dollars—to the claimants, Christus Health Gulf Coast v. Carswell. It could also have an impact on the medical liability coverage available to pathologists who perform autopsies in the Lone Star State.

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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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Clinical Pathology Abstracts, 2/16

February 2016—Link between a liberal transfusion strategy and patient survival: Guidelines support using a restrictive strategy for blood transfusion management in various clinical settings. However, randomized controlled trials in cardiac surgery, oncology, and hip fracture surgery suggest that a more liberal transfusion strategy may benefit survival.

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Anatomic Pathology Abstracts, 2/16

February 2016—Subtype classification of lung adenocarcinoma in patients undergoing complete resection: The classification for invasive lung adenocarcinoma by the International Association for the Study of Lung Cancer, American Thoracic Society, European Respiratory Society, and World Health Organization is based on the predominant histologic pattern—lepidic, papillary, acinar, micropapillary, or solid—present in the tumor.

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Newsbytes, 2/16

February 2016—IT staffing considerations for the NGS laboratory: For the past five years, the University of Washington Department of Laboratory Medicine has been expanding its next-generation sequencing capabilities, adding the latest technologies and offering new tests in genetics, cancer, and infectious disease—and honing its information technology staffing skills along the way.

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Q&A column, 2/16

February 2016— I am a practicing board-certified pathologist and I have one cytotechnologist to screen Pap tests. She is moving to another city, and I must decide whether to send all Paps to a reference laboratory or to another lab just for screening and then returned to me for sign-out of normal and abnormal Paps.

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Put It on the Board, 1/16

January 2016—2016 may be year of action on laboratory-developed tests: During a session at the Association for Molecular Pathology’s annual meeting in November, Rep. Michael Burgess, MD (R-Tex.), said he expects the Food and Drug Administration to issue its long-awaited final guidance on laboratory-developed tests during the first quarter of 2016.

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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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From the President’s Desk: Flexibility matters, 1/16

January 2016—Pathology is becoming more vital, complex, variable, integrated, and interactive. Once upon a time, we trained to enter practice. Today, we must train to be continually trained. Our ability to stay current with science and explain its potential is a critical variable in the quality of care our patients receive. As a department chair and laboratory medical director, I encourage each member of our group to embrace a coordinated approach.

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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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Molecular Pathology Selected Abstracts, 1/16

January 2016—Genomic sequencing of tumors can be used clinically to identify acquired somatic mutations in cancer-related genes. In an era of personalized medicine, tumor-specific mutational status can be used to acquire prognostic information and guide molecular targeted therapies. However, many patients also have germline variants in these genes, which not only can make it difficult to identify the tumor-specific somatic mutations, but may also affect the biological mechanism of tumorigenesis.

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Anatomic Pathology Abstracts, 1/16

January 2016—Uterine leiomyosarcomas are rare malignant tumors with a poor prognosis, while leiomyomas are common benign tumors unrelated to their malignant counterparts. Diagnostic features commonly present in leiomyosarcoma include cytologic atypia, high mitotic index, and a sarcoma-specific geographic cell death designated as tumor cell necrosis (TCN).

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Newsbytes, 1/16

January 2015—As the trend in cloud computing continues, in part as a way to reduce capital investment costs, laboratory decision-makers must learn the nuances of how to vet this type of vendor and negotiate software-as-a-service agreements. Without this knowledge, they risk entering into a less-than-satisfactory contractual arrangement that can cost them money, industry experts say.

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Clinical Pathology Abstracts, 1/16

January 2016—A logical delta check for identifying erroneous blood cell count results: Regulations require that hospitals have a quality management plan that benchmarks key indicators of quality performance. One such indicator is a delta check, which is a broad quality control for preanalytic and analytic errors that identifies significant variation in a patient’s present lab result when compared with the patient’s previous result for the same test.

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Q&A column, 1/16

January 2016—The current recommendation of the Centers for Disease Control and Prevention to screen baby boomers for hepatitis C virus may cause stress on laboratory resources. Is this the most prudent way to capture those individuals who will progress to liver cancer? Current data/literature suggest that 80 percent of those who may screen positive will not progress to cancer but will eliminate the virus on their own.

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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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Clinical Pathology Abstracts, 12/15

December 2015—Optimizing transfusion ratios in massive transfusion protocols: The 1:1:1 ratio of packed red blood cells to plasma to platelet use for massive transfusion emerged out of data on mortality in military personnel wounded in combat. Many studies have investigated the optimal ratio for use in massive transfusion. The literature is controversial, and studies continue to support and refute the 1:1:1 ratio.

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Anatomic Pathology Abstracts, 12/15

December 2015—Reappraisal of etiologic field effect in cancer predisposition and progression: The term field effect, which is also known as field defect, field cancerization, and field carcinogenesis, has been used to describe a field of cellular and molecular alteration that predisposes to the development of neoplasms within that territory.

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Newsbytes, 12/15

December 2015—Fellowship blends clinical informatics and pathology: Ask Rebecca Johnson, MD, and her colleague Bruce Levy, MD, about a newly approved fellowship program that allows fellows to train concurrently in clinical informatics and any other of the pathology subspecialties, and they’ll give you a similar answer: This has been in the works for a long time.

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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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Molecular Pathology Selected Abstracts, 11/15

November 2015—Off-label use of molecularly targeted therapy: Advances in technology allow for genetic and molecular profiling of tumors, findings that are useful for guiding molecularly targeted therapy. Molecularly targeted agents are usually tested and developed on groups of tumors based on histologic type and primary location, but many genetic abnormalities overlap across tumor types.

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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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Anatomic Pathology Abstracts, 11/15

November 2015—Variation in reporting extraprostatic extension after radical prostatectomy: Extraprostatic extension of prostate cancer in radical prostatectomy specimens significantly affects patient management. The authors evaluated the degree of interobserver variation between uropathologists at a tertiary referral teaching hospital in assessing the extraprostatic extension of prostate cancer in radical prostatectomy specimens.

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Put It on the Board, 11/15

November 2015—Approvals mark ‘tip of the iceberg’ for PD-L1 testing: What the FDA giveth, the FDA may taketh away. On Oct. 2, the agency approved the use of Merck’s immunotherapy drug Keytruda (pembrolizumab) to treat patients with metastatic non-small cell lung cancer whose disease has progressed after chemotherapy and whose tumors express the PD-L1 protein. Dako’s IHC 22C3 pharmDx test kit was approved as a companion diagnostic for use with the drug.

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Newsbytes, 11/15

November 2015—Collaborative prepares pilot on managing genomic data in EHRs: As genetic testing travels the path from rare to routine, it simultaneously provides answers and poses problems. One such problem is rooted in the question, How can electronic health record systems organize and display genomic information in a standardized, interoperable format that best supports clinical decision-making?

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Q&A column, 11/15

November 2015—Is there a recommended procedure for or reference article about checking APTT reagent sensitivities (for the identification of factors VIII and IX) when changing lot numbers and reference range? The activated partial thromboplastin time (APTT) clot-based assay is a global test used to detect factor deficiencies in patients with a bleeding diathesis or as a preoperative screen to ensure normal coagulation laboratory parameters before an invasive procedure.

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Clinical Pathology Abstracts, 11/15

Editor: Deborah Sesok-Pizzini, MD, MBA, professor, Department of Clinical Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, and chief, Division of Transfusion Medicine, Children’s Hospital of Philadelphia. Altered lysosomal proteins in neural-derived plasma exosomes in preclinical Alzheimer disease It is necessary to identify biomarkers to detect patients at risk for Alzheimer disease well before neurological signs ...

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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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Put It on the Board, 10/15

Neuropathologist Dr. Omalu in spotlight at CAP ’15: Bennet Omalu, MD, MBA, MPH, who gave the spotlight event speech at CAP ’15 earlier this month, says he met retired Pittsburgh Steeler Mike Webster before conducting the 2002 autopsy that would lead to the first diagnosis of chronic traumatic encephalopathy in a National Football League player.

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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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From the President’s Desk: First things first, 10/15

October 2015—As I mulled over the best way to begin my first column, two classes I had taken long ago came to mind. The first was part of an intensive undergraduate philosophy program at Stanford in 1978. The second, on organizational behavior, was part of a master’s program in health care management at Harvard 20 years later. In each case, I expected little more than a series of fuzzy discussions. Instead, the components I thought would be the lightest were the deepest.

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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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Newsbytes, 10/15

October 2015—A decade later, online laboratory handbook gets makeover: Ten years ago, when Massachusetts General Hospital created an online laboratory handbook, the event crowned many hours of programming and coding by a team of pathologists, who were convinced their labors would dramatically streamline access to information.

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Clinical Pathology Abstracts, 10/15

October 2015—Impact of a rapid respiratory panel test on patient outcomes: Studies have examined the impact of polymerase chain reaction tests on patient outcomes. Rapid detection in microbiology and virology allows more appropriate treatment sooner. This, in turn, can reduce hospital length of stay for patients with respiratory pathogens and may generate hospital savings.

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Anatomic Pathology Abstracts, 10/15

October 2015—CD117 expression in phyllodes tumors: correlation with adverse pathologic parameters. CD117 (c-Kit) is a type III receptor tyrosine kinase encoded by the KIT gene. Deregulation of expression and mutations in the gene are implicated in various tumors. Reports of CD117 expression in phyllodes tumors have generated controversy.

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Molecular Pathology Selected Abstracts, 10/15

October 2015—Mutation clearance after induction therapy in acute myeloid leukemia: After initial induction chemotherapy for acute myeloid leukemia, approximately 20 percent of patients fail to achieve complete remission, and approximately 50 percent experience relapse within one year. Therefore, it would be clinically useful to identify patients at higher risk of induction therapy failure or relapse.

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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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Q&A column, 9/15

September 2015—In the article on novel oral anticoagulants in the May 2015 issue of Archives of Pathology & Laboratory Medicine (139:687–692), a few blood products that are mentioned are not described. What is the composition of 3-factor PCC, 4-factor PCC, and FEIBA, and how are they prepared commercially?

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Newsbytes, 9/15

September 2015—How site visits led to an LIS selection at Stanford: Seven gets all the attention, but five turned out to be the lucky number for a Stanford University Medical Center team charged with selecting a new laboratory information system. Visiting five installation sites in five cities in five days was “probably the most important aspect of the whole process,” says Brent Tan, MD, PhD, director of clinical laboratory informatics at Stanford.

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Put It on the Board, 9/15

September 2015—Roche buys ‘sample in, susceptibility out’ technology: Roche has signed a definitive agreement to acquire Los Gatos, Calif.-based GeneWeave BioSciences, a privately held company focused on molecular clinical microbiology diagnostic solutions. The acquisition provides Roche with GeneWeave’s Smarticles technology, which quickly identifies multidrug-resistant organisms and assesses antimicrobial susceptibility directly from clinical samples without the need for traditional enrichment, culture, or sample preparation processes.

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Molecular Pathology Selected Abstracts, 9/15

September 2015—Molecular profile of diffuse lower-grade gliomas: Diffuse low- and intermediate-grade gliomas include World Health Organization grade II and III astrocytomas, oligodendrogliomas, and oligoastrocytomas. These lower-grade gliomas usually arise in the cerebral hemispheres of adults, and they are highly infiltrative and, therefore, cannot be completely resected.

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Clinical Pathology Abstracts, 9/15

September 2015—Costs and outcomes after cardiac surgery in patients refusing transfusion: Numerous randomized, controlled trials have shown no benefit of a liberal blood transfusion strategy compared with a more restrictive strategy in surgical patients. Furthermore, concerns exist regarding the association of transfusion with postoperative morbidity and mortality.

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Anatomic Pathology Abstracts, 9/15

September 2015—Tumor-infiltrating lymphocytes and response to neoadjuvant chemotherapy in select breast cancers: Modulation of immunologic interactions in cancer tissue is a promising therapeutic strategy. To investigate the immunogenicity of HER2-positive and triple-negative breast cancers, the authors evaluated tumor-infiltrating lymphocytes and immunologically relevant genes in the neoadjuvant GeparSixto trial.

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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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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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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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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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From the President’s Desk: Partnerships for patients

September 2015—This is my last column, so the bad news is that it’s time to go. But the good news is that by the time you read this, we’ll be heading into CAP ’15, where many of us will continue this conversation in person. If you cannot come this year, I hope you will at least plan lunch afterward with someone who did. We always return to work infused with energy and optimism. At least you can tap into that.

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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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Q&A, 8/15

August 2015—Our laboratory is adding urine total protein to its Siemens Dimension EXL test menu. The test is being performed now at our reference lab on the Siemens Advia 1800. Our Dimension EXL method validation studies have revealed an average 40 percent positive bias over the Advia method. This bias is also evident in peer group evaluations for the quality control product we are using.

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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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Letters, 08/15

August 2015—Breast pathology study: I read the letter by Diane Schecter, MD (July 2015), and I respect her right to remind readers that the findings from the breast pathology study published in JAMA (Elmore JG, et al. 2015;313:1122–1132) are similar to results published nearly 25 years ago.

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From the President’s Desk: Showing what is in our hearts

August 2015—The CAP Foundation See, Test & Treat program is one of the best things we do. I like that it is patient centric and volunteer driven. I like that it is multidisciplinary, collaborative, and community based. I like that it is quietly disrupting how underserved populations experience the health care system and how we relate to our clinical partners. And I like knowing that something that does so much good for everyone it touches is pathologist led—which means we are forever examining, growing, and improving it as only we can do.

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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 | 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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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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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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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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Anatomic Pathology Selected Abstracts, 8/15

August 2015—Quality of diagnostic staging in patients with bladder cancer: a process-outcomes link: Muscle sampling is often used as a surrogate for staging quality in patients with bladder cancer. The association of staging quality at diagnosis and survival was examined among patients with bladder cancer. The clinical records of all individuals within the Los Angeles Surveillance, Epidemiology, and End Results registry with an incident diagnosis of nonmuscle-invasive bladder cancer in 2004–2005 were reviewed.

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Clinical Pathology Abstracts, 8/15

August 2015—Characteristics and antibiotic use associated with short-term risk of C. difficile infection in hospital patients: Clostridium difficile infection is recognized as the leading cause of infectious nosocomial diarrhea. Since molecular testing has improved the sensitivity and specificity of C. difficile infection (CDI) diagnosis, most hospitals discourage repeating a negative test within seven days. However, there is a rare possibility that a patient may have repeat CDI testing that is positive within 14 days after an initial negative finding.

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Molecular Pathology Selected Abstracts, 8/15

August 2015—Studying clonal dynamics in response to cancer therapy using barcoding: The emergence of resistance to targeted cancer therapeutics is a significant problem clinically and is generally believed to result from genetic alterations in tumor cells. Whether resistance exists within a subpopulation of a tumor prior to treatment or develops de novo during treatment is a fundamental question that may significantly impact therapy.

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Newsbytes, 8/15

August 2015—How one pathologist made use of artificial intelligence: Like many pathologists, Jay J. Ye, MD, PhD, longed to spend less time preparing reports and more time interpreting slides and rendering diagnoses. Rather than dedicating half of his workday to what he considers secretarial tasks, the dermatopathologist wanted to devote the lion’s share of his hours in the lab toward applying the knowledge and skills he developed during his years of medical training and practice.

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Put It on the Board, 8/15

August 2015—To meet TAT goals, Vanderbilt builds ED lab: In a move expected to help meet accreditation standards on testing turnaround times for stroke and chest pain patients, Vanderbilt University Medical Center’s emergency department will gets its own satellite laboratory this month.

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Put it on the Board, 7/15

July 2015—Amid excitement about the groundbreaking work of unlocking the human genome’s secrets to speed diagnosis and target oncologic treatment comes the unpleasant reality that much of this labor now goes unpaid. Getting the American Medical Association’s editorial panel to publish nearly two dozen new genomics-related CPT codes for molecular pathology was a vital step, as was having those codes accepted in the Medicare clinical laboratory fee schedule.

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Anatomic Pathology Selected Abstracts, 7/15

July 2015—Expanding the morphologic spectrum of differentiated VIN by mapping p53 loss; Mitotic count by PHH3 immunohistochemical staining in pancreatic WDNETs; Comparison of prostate cancer markers in lymph node and distant metastases; Evaluation of a new grading system for laryngeal squamous intraepithelial lesions; Breast cancer assessment based on levels of estrogen receptor expression ...

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Newsbytes, 7/15

July 2015—Why Sonora Quest gave itself high marks for LIS conversion; Pathologists share homegrown software for infant autopsies; CMS promotes innovation by offering data to private sector; Agilent purchases Cartagenia; Database provides information from next-gen sequencing

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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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From the President’s Desk: Our role in shared decision-making, 7/15

July 2015—Responsibilities as medical director for transfusion and coagulation services at Nebraska Methodist Hospital in Omaha occupy about 15 percent of my time. We have an excellent staff, the work is satisfying, and I enjoy the patient contact. In 2007, we became one of what are now three hospitals in Nebraska with recognized blood conservation programs and one of about 150 nationally that accommodate patients who refuse or restrict blood use for personal or religious reasons. Many of these patients travel a significant distance to reach us.

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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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Q&A column, 7/15

July 2015—Q. We recently reorganized the workflow in our blood bank in hopes of improving process control and reducing distractions. In doing so, we increased the potential for workplace injuries. The ergonomic issues are a major concern for a lot of workers. Employees on all three shifts are developing back and knee issues. We are an 800-plus-bed hospital lab with more than 30 people working in our department. The following issues have arisen:

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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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Anatomic Pathology Selected Abstracts, 6/15

June 2015—Safety and diagnostic accuracy of tumor biopsies in children with cancer; Napsin A as a specific marker for ovarian clear cell adenocarcinoma; Long-term follow-up of an active surveillance cohort of patients with prostate cancer; Primary sources of pelvic serous cancer in patients with endometrial intraepithelial carcinoma; Re-evaluating the role of sentinel lymph node biopsy in microinvasive breast carcinoma; Molecular analyses of six types of uterine smooth muscle tumors

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Clinical Pathology Selected Abstracts, 6/15

June 2015—Effects of red cell storage duration on patients undergoing cardiac surgery: Patients who undergo cardiac surgery often receive multiple units of red blood cells and may be at risk for end-organ injury because of compromised cardiac output or a proinflammatory state that follows cardiopulmonary bypass. At least one large study has shown an increase in adverse outcomes in patients receiving RBCs stored longer than 14 days compared with those receiving RBCs stored less than 14 days.

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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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Newsbytes, 6/15

June 2015—Consortium gaining ground in quest for interoperability; Xifin purchases VisualShare; CDC releases update on electronic lab result reporting to public health agencies; Enzo Life Sciences releases ELISA plate reader app; Orchard Software features white papers on website; Imprivata expands reach with acquisition of HT Systems; Sampleminded teams up with Exact Sciences

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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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Letters, 5/15

May 2015—Speech recognition: I found the article on speech recognition to be well reported and interesting (“Hear me now? Another audition for speech recognition,” March 2015). We implemented speech recognition at NorthShore University HealthSystem (as your writer reported) before I retired as director of the clinical pathology division. What William Watkin, MD, said in the article about our smooth implementation was so true.

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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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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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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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Q&A column, 5/15

May 2015—Q. I am a pathologist practicing in a small community hospital. I was involved with a patient who was declared brain-dead and subsequently designated a donor of multiple organs. The organ procurement agency ordered additional testing during the two days before the organ harvest, including a CT scan of the chest. The latter revealed a solitary pulmonary nodule.

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Anatomic Pathology Selected Abstracts, 5/15

Editors: Michael Cibull, MD, professor emeritus, University of Kentucky College of Medicine, Lexington; Rouzan Karabakhtsian, MD, attending pathologist, Department of Pathology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; Thomas Cibull, MD, dermatopathologist, Evanston Hospital, NorthShore University HealthSystem, Evanston, Ill.; and Rachel Stewart, DO, resident physician, Department of Pathology and Laboratory Medicine, University of Kentucky. Molecular detection of ...

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Clinical Pathology Selected Abstracts, 5/15

May 2015—Use of hemoglobin content of reticulocytes to evaluate anemia in cancer patients: Evaluating iron-deficiency anemia in patients with cancer is difficult. Malignancy is frequently associated with anemia of chronic disease. However, it is important to distinguish iron-deficiency anemia due to inadequate iron stores from anemia of chronic disease due to decreased iron availability with abundant stores. Advanced reticulocyte indices, such as the cellular hemoglobin content of reticulocytes, named CHr and RET-He, are reportable parameters on newer automated hematology analyzers.

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Molecular Pathology Selected Abstracts, 5/15

May 2015—Clinical and molecular effects of order of acquired mutations in myeloproliferative neoplasms: Cancers arise and evolve from the accumulation of somatic mutations. With the addition of each mutation, tumor subclones are selected for biologic attributes that increase growth and proliferation potential. However, the authors hypothesized that it may not only be the presence of the mutations that affects these attributes but also the order in which the mutations arise, since their interactions and resulting environment likely play a key role in the development of subsequent genetic events and the tumor’s neoplastic behavior.

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Newsbytes, 5/15

May 2015—A lab IT strategic plan: from guidance to lessons learned: For those with even the slightest bit of health care business acumen, it should come as no surprise that when health systems expand quickly through mergers and acquisitions, hospital labs often struggle to communicate and cooperate with their counterparts at far-flung sister sites. Faced with such a challenge, the lab at the rapidly growing Geisinger Health System embraced a solution.

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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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Put It on the Board, 4/15

April 2015—Door opens on direct access to genetic tests: The FDA’s recent move to give 23and­Me permission to market this country’s first direct-to-consumer genetic test, for Bloom syndrome, goes beyond the one in 107 Jews of Ashkenazi descent who are carriers of the rare disorder.

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Anatomic Pathology Selected Abstracts, 4/15

April 2015—Uterine smooth muscle tumors with features suggesting fumarate hydratase aberration; Histologic and immunohistochemical assessment of penile carcinomas in a North American population; Predictive value of IASLC/ATS/ERS classification of lung adenocarcinoma in tumor recurrence and patient survival; Histomorphology of Lynch syndrome-associated ovarian carcinomas with regard to a screening strategy

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Newsbytes, 4/15

April 2015—How a best practice alert cut unneeded transfusions: Embedding a decision support tool in an EMR to nudge physicians toward an evidence-based practice—without ruffling feathers—can be a delicate process. But two physicians at Dartmouth-Hitchcock Medical Center did just that when they launched a best practice alert that encourages adherence to new guidelines for ordering blood.

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Q&A column, 4/15

April 2015—Why is the number 12 for lymph node retrieval in colon cancer protocol reporting not specific to the kind of resected specimens and whether a total colectomy was performed? We are establishing a list of maximum allowable dilutions for our clinical chemistry analytes. Are you aware of any reference that would list absurd or invalid values for such analytes, i.e. the endpoint that would determine the most dilutions we would have to do for the highest possible value for that analyte?

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Molecular Pathology Selected Abstracts, 4/15

April 2015—Interpreting pathogenic variants in TTN for dilated cardiomyopathy: In this era of expanding gene panels and whole-exome and whole-genome sequencing for rare disease molecular diagnostics, it remains a challenge to filter numerous resulting variants from these sequencing assays, assign functional consequences of a variant in the resulting protein, and then determine potential pathogenicity.

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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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From the President’s Desk: Together, we gain more than we give, 4/15

April 2015—Before I could become your president, my partners had to agree to cover for me. I would be away a lot and it would be more work for everyone. We talked about it, weighed the impact on our practice, considered what it would mean for them, and came to a consensus. I would be the person whose picture appeared on this page. They would have a decisive role in making it possible.

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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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From the President’s Desk: Transitions in training and practice

March 2015—Turning points emerge in retrospect, but I’m ready to put a red pushpin at December 2013 on the evolutionary timeline for pathology graduate medical education. Twenty-four pathology education organizations came together that month for a workforce summit sponsored by the CAP, the American Society for Clinical Pathology, the Association of Pathology Chairs, and the United States and Canadian Academy of Pathology that would refine consensus on how to best shape the future of our specialty.

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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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Q&A column, 3/15

Are red blood cell parameters (Hb, MCV, MCH, MCHC, and RDW), especially a normal MCV, a reliable screening tool for ruling out beta thalassemia trait? Is the sickle solubility test reliable in ruling out sickle cell disorder? The absence of coagulation of seminal fluid has been attributed to bilateral congenital absence of the vas deferens and seminal vesicles due to the absence of the coagulation substrate (fibrinogen-like precursor).

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Anatomic Pathology Selected Abstracts, 3/15

March 2015—Histopathologic spectrum of thecoma of the ovary: a report of 70 cases: The authors evaluated 70 cases of thecoma of the ovary to ascertain their histopathologic spectrum. The tumors occurred over a wide age range (average, 49.6 years). Presentation in the form of pelvic or abdominal pain was uncommon, but postmenopausal bleeding was relatively frequent.

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Newsbytes, 3/15

March 2015—CMS to alter reporting period for meaningful use: The Centers for Medicare and Medicaid Services has announced that it intends to engage in rulemaking to shorten the reporting period for stage two meaningful use attestation this year from 365 to 90 days under the EHR incentive programs.

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Clinical Pathology Selected Abstracts, 3/15

March 2015—Chimeric antigen receptor T cells for sustained remissions in leukemia: Relapsed and refractory acute lymphoblastic leukemia is associated with a poor prognosis. T cells genetically modified to express chimeric antigen receptors targeted to cells expressing CD19 (CTL019) are a promising treatment strategy, with complete responses previously reported in two patients who had relapsed and refractory acute lymphoblastic leukemia (ALL).

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Put It on the Board, 3/15

AMP outlines laboratory view on incidental findings: The American College of Medical Genetics and Genomics’ controversial 2013 recommendations on the reporting of incidental findings on select genes was the first attempt to address the matter in the clinical setting. But the ACMG’s recommendations pose significant challenges that labs undertaking next-generation sequencing must be prepared to address, said a special report written by an Association for Molecular Pathology working group.

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Put It on the Board

February 2015—Two medical organizations said that using an HPV test alone for cervical cancer screening is an effective alternative to the current recommendation for screening with either cytology alone or cotesting with cytology and HPV testing. Pathology leaders said the multispecialty-developed guidance leaves the Pap test standing as a first-line screening option.

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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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Anatomic Pathology Selected Abstracts, 2/15

February 2015—Alteration of ARID1A gene, PI3K-Akt pathway, and ZNF217 gene in ovarian clear cell carcinoma: AT-rich interactive domain 1A (ARID1A) is a subunit of switch/sucrose nonfermentable (SWI/SNF) complex. Recently, alterations of the ARID1A gene, phosphatidylinositol 3-kinase-protein kinase B (PI3K-Akt) pathway, and zinc-finger protein 217 (ZNF217) gene have been identified as frequent molecular genetic changes in ovarian clear cell carcinoma.

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Newsbytes, 2/15

February 2015—Simplifying the search for units of uncommon blood: For blood banks, obtaining red blood cell units with uncommon blood types can be a time-consuming and daunting task in which delays can hinder patient care. So two blood bank professionals, frustrated by the challenge, set out to change that. The American Rare Donor Program fields requests for rare blood types, which are blood types found in fewer than one in 1,000 donors, but it is “not set up to serve those requesting uncommon units—defined as blood with combinations of antigens that occur in fewer than one in 100 people,” says Connie Westhoff, PhD, director of immunohematology and genomics at New York Blood Center.

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Q&A column, 2/15

February 2015—Can our laboratory use ALK immunohistochemistry in lung adenocarcinoma to select patients for targeted therapy? ALK gene rearrangements (the most common of which results in expression of the EML4-ALK fusion protein) are found in approximately five percent of lung adenocarcinomas, and these ALK-rearranged tumors show marked clinical response to the tyrosine kinase inhibitor crizotinib.

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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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Clinical Pathology Selected Abstracts, 2/15

February 2015—Alcohol consumption relative to type of breast cancer risk in postmenopausal women: Alcohol consumption is a known risk factor for breast cancer, but it is not known which subtypes of breast cancer, if any, are more likely associated with alcohol consumption. The authors conducted a large study using the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial cohort to test for heterogeneity in alcohol-related risk by breast cancer subtypes defined by estrogen receptor (ER) and progesterone receptor (PR) status and histological type.

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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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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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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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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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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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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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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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From the President’s Desk: Making disaster readiness routine, 1/15

January 2015—Ebola virus disease had taken 6,900 lives in West Africa and exactly one in the United States as of Dec. 18, 2014. The World Health Organization in August had declared the West African crisis to be a public health emergency of international concern. Yet EVD received little attention in the U.S. until a patient who had traveled from Liberia was diagnosed at Texas Presbyterian Hospital in Dallas on Sept. 30 and died eight days later.

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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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Cytopathology and More | Touch Imprint/Crush Prep Program better by another name?

January 2015—Do you need a proficiency testing tool for your pathologists and cytotechnologists who perform rapid on-site evaluation? Could you benefit from fine-tuning your cytopathology interpretive skills for the assessment of CT- and ultrasound-guided core biopsies and fine-needle aspirations? Are you looking for a new tool to enhance intraoperative consultation and shorten turnaround time? Why not try the online Touch Imprint/Crush Preparation Program?

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Cytopathology and More | FNA specimens for HPV molecular testing in head and neck SCC

January 2015—Fine-needle aspiration plays a large role at many institutions in the diagnosis of head and neck cancers, and aspiration of enlarged cervical lymph nodes in older individuals is among the more common requests for cytology services. Being that squamous cell carcinoma is by far the most common epithelial malignancy of the head and neck region and that cervical lymphadenopathy in older individuals is one of the more frequent initial manifestations, optimizing these aspirations to direct patient care is a worthy goal.

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Molecular Pathology Selected Abstracts, 1/15

January 2015—Age-related mutations linked to clonal hematopoietic expansion and malignancies: A common practice in molecular profiling of tumors is to subtract mutations detected in DNA derived from blood (representing germline or inherited polymorphisms) from mutations detected in DNA derived from the paired tumor to assess the tumor’s somatic molecular profile.

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Anatomic Pathology Selected Abstracts, 1/15

January 2015—Are amended surgical pathology reports reaching the correct care provider? Amended reports need to follow patients to treating physicians to avoid erroneous management based on an original diagnosis. The authors undertook a study to determine if amended reports followed patients appropriately. They tracked amended reports with diagnostic changes and discrepancies between ordering and treating physicians.

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Put It on the Board, 1/15

January 2015—Digitized slides spur patient engagement, ‘allow for democratized medicine’. Regulatory and reimbursement hurdles are key factors blocking broader adoption of digital pathology. But the technology is already having an impact, enabling patients to grasp a firmer hold of the wheel in directing their care, said Keith J. Kaplan, MD, a pathologist and laboratory medical director in Charlotte, NC.

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Labs entering risky payment game in the new year

January 2015—This year will bring a host of regulatory, coding, billing, and payment changes that are going to challenge pathologists and laboratory administrators to move quickly or else face declining revenue and the grim specter of Medicare recovery audits. That was the somber consensus of three experts gathered for a December webinar hosted by The Dark Report.

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Transplant pathology atlas practical and to the point

January 2015—If a picture is worth 1,000 words, what are 300 solid-organ transplant biopsy slides worth? Don’t bother doing the math. No matter how you calculate it, the new Atlas of Transplant Pathology—which features more than 300 illustrations and is available this month from CAP Press—represents a wealth of concrete, up-to-date information on the pathologic diagnoses seen in heart, kidney, liver, lung, and pancreas transplants.

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Newsbytes, 1/15

January 2015—Desire to stem lab test overuse leads to free software: For Zia Uddin, PhD, enough was enough. After reading time and again about the proliferation of redundant and otherwise medically unnecessary laboratory testing in the U.S. health care system, the clinical chemist and computer scientist decided to take matters into his own hands—quite literally.

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Massive transfusion: a question of timing, detail, a golden ratio

December 2014—Here it was, the kind of massive postpartum hemorrhage case for which the team at Duke University Medical Center had spent months preparing. The multidisciplinary group had agreed on which laboratory tests would be done in such a case, determined which blood products would be delivered, and decided which members of the OB team would be sent racing to retrieve the potentially life-saving package.

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Anemia: classification challenge and clinical questions

December 2014—Anemia is in the eye of the classifier. While that’s not as elegant as the “beauty-beholder” saying, it’s much more important. To be able to effectively treat and diagnose anemia, “You have to know what is causing the decrease in red cells,” said Sherrie Perkins, MD, PhD, speaking at an AACC workshop this year. There are plenty of definitions to choose from, said Dr. Perkins, of the University of Utah/ARUP Laboratories, Salt Lake City. At the most basic level, she noted, anemia is a pathologic condition marked by a reduced capacity of blood to transport and deliver adequate oxygen to tissues. In short, anemia is a manifestation of disease, not a disease itself.

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Study: elevated vancomycin MICs no cause for concern

December 2014—Elevated vancomycin minimum inhibitory concentrations do not increase the risk of death in patients with Staphylococcus aureus bacteremia, according to the findings of a comprehensive meta-analysis published in the Oct. 9 issue of JAMA. Despite widespread speculation about rising vancomycin resistance, or “MIC creep,” the authors find little evidence to challenge the current CLSI susceptibility breakpoint of ≤ 2 µg/mL for vancomycin.

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From the President’s Desk: Are we there yet?, 12/14

December 2014—At this time of year, when we are inclined to reminisce, I often recall holiday travel with small children. I mention this to explain my headline—an existential question also relevant to our work at the CAP. When those around the table begin to debate a point (say, for example, during a CAP Board of Governors meeting), I sometimes recall voices. I suspect that’s true for many of us.

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Amid Ebola preparation, an EV-D68 outbreak

December 2014—In addition to preparing for Ebola patients, many clinical laboratories and hospitals in recent months faced outbreaks of respiratory illness caused by enterovirus D68 among children. “EV-D68 infections may be associated with severe acute respiratory illness, viral pneumonia, and severe reactive airway disease,” says Susan Novak, PhD, D(ABMM), director of microbiology at Kaiser Permanente Regional Reference Laboratories in Southern California. Focal limb weakness has also been reported as possibly related to EV-D68, she adds.

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From tumor board, an integrated diagnostic report

December 2014—The handling of molecular information bears a certain resemblance to Wall Street’s bundling of mortgages in recent years. You can slice ’em, dice ’em, and repackage them in all sorts of ways. In medicine, however, this is being done—one would hope—without the ensuing meltdown. The goal is to shape personalized medicine, using the results of next-generation sequencing and other technologies to evaluate genetic information ranging from single gene to whole exome or whole genome, with proteomics possibly not too far behind.

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Molecular Pathology Selected Abstracts, 12/14

December 2014—Overcoming limitations in the sequencing of whole viral genomes: The identification and analysis of pathogenic viruses, especially the Ebola virus, has recently received significant attention. The sequencing of newly identified viral genomes has presented historical challenges as existing technology fails to capture the 3’ and 5’ terminal ends of the viral genome.

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Full speed ahead through tight corners

December 2014—Like sailing ships, laboratories hope for fair winds as they chart their business plans. But smooth sailing is never a sure bet; rough sea conditions are an ever-present possibility that can make ships hard to steer. Perhaps the tide is with the vessel but the winds are against it. That’s a situation that could aptly describe a health care system facing a growing patient population at the same time that hospital admissions and reimbursement are in decline.

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Newsbytes, 12/14

December 2014—Why lab report formatting remains a work in progress: As a guiding principle, “form follows function” may be as appropriate for pathology reports as it was for 20th century architecture and industrial design. So, if the primary function of a lab report is to communicate diagnostic information, it should be designed and formatted to make it easy for the reader to assimilate data that will impact patient care. But achieving this result may require due diligence, say two pathologists who have embraced the cause of better-looking, more effective reports.

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Put It on the Board, 12/14

December 2014—Crizotinib shrinks tumors in ROS1-positive NSCLC: A recently published New England Journal of Medicine study that shows promise for the treatment of ROS1-positive lung cancer patients also demonstrates the value of advanced diagnostics, says John Iafrate, MD, PhD, the article’s senior author. Thirty-six of 50 study participants whose non-small cell lung cancer was driven by a rearrangement of the ROS1 gene saw their tumors shrink significantly when they received treatment with the drug crizotinib (Xalkori). The drug suppressed tumor growth in another nine ROS1-positive patients in the study, a phase one trial.

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Q&A column, 12/14

December 2014—What are the legal ramifications for medical technologists or medical laboratory technicians if they release results on suboptimal specimens on the insistence of physicians? What are the consensus recommendations for the diagnosis of eosinophilic esophagitis, eosinophilic gastroenteritis, and eosinophilic colitis? What is the clinical significance of increased lymphocytes in esophageal biopsy? Has there been a significant increase in diagnosed eosinophilic disorders over the past 10 or so years?

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Clinical Pathology Selected Abstracts, 12/14

December 2014—Prevalence of antimicrobial use in U.S. acute care hospitals: Inappropriate antimicrobial drug use is associated with adverse events in hospitalized patients as well as the emergence of resistant pathogens. Targeting effective interventions to improve antimicrobial use in the acute care setting may help guide safe and effective therapy while reducing the risks and complications of resistant and difficult-to-treat pathogens.

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Anatomic Pathology Selected Abstracts, 12/14

December 2014—Value of autopsies in the era of high-tech medicine: Although the autopsy is still the gold standard for quality assessment of clinical diagnoses, autopsy rates have declined to less than 10 percent. The authors conducted a study to investigate the value of autopsies in the era of high-tech medicine by determining the frequency of discrepancies between clinical and autopsy diagnoses. The authors classified all adult autopsy cases (n=460) performed at the Symbiant Pathology Expert Centre in Holland, in 2007 and from 2012 to 2013, as having major or minor discrepancy or total concordance.

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Labs ramp up for Ebola patients, specimens

December 2014—Clinical laboratories have made impressive headway in their Ebola preparedness, though their plans are shaping up in different ways. That’s due, in part, to varying opinions about how to manage a dangerous and unpredictable virus. “We are really learning as we go along with this,” says D. Jane Hata, PhD, D(ABMM), director of microbiology and serology at Mayo Clinic in Jacksonville, Fla. For years there has been talk of the possibility of an airplane passenger bringing Ebola into the U.S., she says. “But we are on the ground now and we’re all actively planning to deal with this.”

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Anatomic Pathology Selected Abstracts, 1/13

January 2013—Relationship between PAX2-null secretory cell outgrowths in the oviduct and pelvic serous cancer: With the exception of germ-line mutations in ovarian cancer susceptibility genes, genetic predictors for women destined for ovarian serous cancer cannot be identified in advance of malignancy. The authors recently showed that benign secretory cell outgrowths (SCOUTs) in the oviduct increase in frequency with concurrent serous cancer and typically lack PAX2 expression (PAX2-null).

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Clinical Pathology Selected Abstracts, 1/13

January 2013—Chocolate consumption, cognitive function, and Nobel laureates: Dietary flavonoids are associated with health benefits, including improved cognitive function and reduced risks associated with aging, such as the risk of dementia. Flavonoids, or the subclass flavanols, are present in green tea, red wine, cocoa, and some fruits. Evidence has also shown that flavanols are linked to lower blood pressure due to vasodilation in the peripheral vasculature and brain.

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Put It on the Board, 11/14

November 2014—Amid initial confusion over Ebola-related safety protocols for health professionals providing direct patient care, laboratory professionals report hearing a consistent message from the CDC on proper specimen handling. The pressing question for laboratories is how best to approach testing with potential Ebola patients given the dual imperatives of preventing exposure and offering faster diagnostic answers.

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Newsbytes, 11/14

November 2014—Software expands on ‘what you see is what you get’; ONC unveils tool for sharing health information with patients; Portal gives patients direct access to lab test results; Xifin partners with SyTrue; GenoSpace awarded grant for developing biorepositories; NovoPath interfaces to Athenahealth EHR

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Molecular Pathology Selected Abstracts, 11/14

November 2014—Whole exome sequencing of Merkel cell carcinoma demonstrates conserved retinoblastoma pathway dysregulation: Merkel cell carcinoma is a rare aggressive neuroendocrine malignancy of the skin that is associated with infection by Merkel cell polyomavirus. Viral integration into the human genome and subsequent expression of the large T antigen is thought to cause cell cycle dysregulation via binding and inactivation of the retinoblastoma tumor suppressor protein and is a key step in the development of Merkel cell carcinoma.

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Anatomic Pathology Selected Abstracts, 11/14

November 2014—Final trial report of sentinel-node biopsy versus nodal observation in melanoma: Sentinel-node biopsy, a minimally invasive procedure for regional melanoma staging, was evaluated in a phase three trial. The authors evaluated outcomes in 2,001 patients with primary cutaneous melanomas who were randomly assigned to undergo wide excision and nodal observation, with lymphadenectomy for nodal relapse (observational group), or wide excision and sentinel-node biopsy, with immediate lymphadenectomy for nodal metastases detected on biopsy (biopsy group).

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Molecular techniques in a case of concurrent BCR-ABL1–positive CML and CMML

November 2014—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. Here, this month, is case No. 6. (See the February, August, and September 2013 and the May and June 2014 issues for the first five.) AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, treatment, and more. Case report No. 6 comes from UT-MD Anderson Cancer Center in Houston.

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How LIS tweaks can enhance efficiency, patient safety

November 2014—So, you have a great idea that will improve laboratory workflow and reduce errors? Chances are the change will depend on automation of some sort, and will involve the LIS. But upgrades to laboratory information systems may not come fast enough, and the middleware may not be available to accomplish what you need. Then the question becomes how to customize the LIS to achieve your aims.

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Big gain theory—data warehousing pays off

November 2014—It’s been said that “data” is the plural of “anecdote,” and debate has swirled around whether that is true. Something about data makes most of us feel that it is qualitatively different: more manipulable, more reliable, more helpful in drawing useful conclusions. But is there a new stage that might be considered the plural of data? These days, the health care industry is excited about a concept that promises to catapult the value of laboratory information into a new era. It’s the Enterprise Data Warehouse.

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NGS informatics catching up to clinical demands

November 2014—When Birgit H. Funke, PhD, gave a talk earlier this year on incorporating bioinformatic tools and pipelines into medical NGS, at Molecular Medicine Tri-Con 2014, one of her slides showed the main bioinformatics activities needed to support sequencing. Among them were designing and building pipelines to manage genetic data, writing scripts for data analysis pipelines, and building custom applications.

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Is molecular AP testing in sync with guidelines?

November 2014—Molecular testing, on a steep growth curve in anatomic pathology, is increasingly providing decisive guidance for treatment of cancer patients. But while guidelines on clinical relevance and performance of common molecular tests are available and widely used in theory, to date there has been limited information on how well requests for molecular testing in AP laboratories are adhering to the guidelines.

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CAP proposals on IHC, PQRS accepted for Medicare in ’15

November 2014—The Centers for Medicare and Medicaid Services on Oct. 31 published its 2015 Medicare physician fee schedule to set payment rates and policy for the next year, including the relative value units for existing and new Current Procedural Terminology codes. Several of the CAP’s recommendations and proposals were accepted for inclusion, such as three new quality measures designed for pathologists and eliminating G-codes to pay for immunohistochemistry services.

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From chaos to order—and compassion—in autopsies

November 2014—Pathology resident Beth Ellen Frost, DO, has at times taken an uncommon step to put family members at ease when they are asked to consent, or have consented, to an autopsy for a loved one: She’s providing her cell phone number. Simple but purposeful, and it’s one part of a new initiative to improve the University of Kentucky HealthCare system’s autopsy process, which has other pathology staff handing out numbers too.

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From the President’s Desk: How we tell our story, 11/14

November 2014—We do what we do because we know it’s important, we find it engaging, and we like to keep things interesting. We are committed to our work and precise by nature. So we spend hours with one patient’s specimens. We build systems-based safety nets to protect quality. We investigate, verify, document. We juggle a bit of everything and work with everyone. No wonder no one knows what we do.

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Q & A column, 11/14

November 2014—When performing a platelet count from a blood sample collected in a sodium citrate tube, the result is multiplied by 1.1 to correct for the volumetric difference in anticoagulant compared to EDTA. Which other CBC parameters, if any, should be similarly corrected?

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From the President’s Desk: Building a quality tradition, 10/14

October 2014—Laboratory medicine is a human endeavor with zero tolerance for error. “Human endeavor” and “zero error” make for an awkward pairing, but those are the rules and they’re good ones. So we create systems to protect quality, sustain excellence, and provide education. We are vigilant. CAP quality assurance programs are instruments of that vigilance and of our member-driven commitment to patient safety.

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Q & A Column, 10/14

October 2014—My laboratory reports the color of a body fluid after it’s spun down. So bloody fluid may be reported as “color: yellow, appearance = bloody.” Is this common practice? We have had phone calls from a neurologist who questioned the color and pointed out that it doesn’t make sense, except for spinal fluid when it’s important to record xanthochromia versus a bad tap.

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AABB ramps up donor screening to help stem TRALI

October 2014—When it comes to the blood supply, the tradeoffs between safety and availability are a tightrope that blood centers walk with extreme care. For several years now, TRALI (transfusion-related acute lung injury) has topped the list of causes of transfusion-related mortality in the U.S. Defined as acute lung injury that occurs during or within six hours of transfusion of a blood product, TRALI is fatal to six to 10 percent of the patients it strikes.

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In lab QC, how much room for improvement?

October 2014—The debut of the CMS’ new quality control option, IQCP, has sharpened the focus on QC in the laboratory and raised hopes that risk management concepts can make QC more robust. But one of the most highly regarded quality control experts in the U.S. voices skepticism about the impact of IQCP—and indeed, about U.S. quality control standards in general.

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Put It on the Board, 10/14

October 2014—Leading pathologists and the CAP are encouraging laboratory professionals to use the social media website Twitter as a way to amplify lab medicine’s voice among clinicians, policymakers, news organizations, patients, and the public. It is advice that at least one prominent social media expert and nonpathology physician says lab professionals ought to heed. “Pathologists have a problem being recognized by society because we don’t see patients directly. This is an opportunity for us to get out there in society and to contribute value in that regard,” says Timothy Craig Allen, MD, JD, a newly elected member of the CAP’s Board of Governors and director of anatomic pathology at the University of Texas Medical Branch, Galveston.

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In free CytoAtlas app, 750 images for 100+ diagnoses

October 2014—Like many cytopathology trainees, Charanjeet Singh, MD, who recently completed a cytopathology fellowship at MD Anderson Cancer Center in Houston, found it challenging at times to find classic examples of entities to learn from and to study for exams. Most texts he consulted contained just one or two images of a particular diagnosis. And the material in training programs from all specialties varies. Even though there is a large volume of cytology cases at MD Anderson, for example, it wasn’t enough to learn gynecologic cytology, which is why he pursued an elective rotation at Houston Methodist Hospital.

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Clinical Pathology Selected Abstracts, 10/14

October 2014—Benefits of green tea extract to brain connectivity during working memory processing: Green tea extract or its main ingredient has been shown to have a beneficial impact on cognitive functioning and prevention of cognitive decline. The benefit to cognition could be related to altered brain activity in regions engaged during higher order cognitive functioning. Some recent studies demonstrated increased brain activation in the fronto-parietal regions during working memory processing.

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Anatomic Pathology Selected Abstracts, 10/14

October 2014—Role of STAT6 immunohistochemistry in diagnosis of solitary fibrous tumors: Solitary fibrous tumor is an uncommon fibroblastic neoplasm. Although histologic characteristics and frequent CD34 expression allow for an accurate diagnosis in the majority of solitary fibrous tumor (SFT) cases, a wide histologic spectrum and occasional unexpected immunophenotype may pose diagnostic challenges. Molecular analyses have shown that almost all SFTs harbor a NAB2-STAT6 fusion gene, which is considered specific to this tumor type.

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Newsbytes, 10/14

October 2014—A conundrum: teaching pathology informatics to residents: Just as high schoolers are prone to protest, “We’re never going to need to use quadratic equations/literary theory/the periodic table in real life,” pathology residents have been known to question the value of subjects for which they don’t envision a practical application—such as pathology informatics.

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Molecular Pathology Selected Abstracts, 10/14

October 2014—A gene panel to examine mosaic somatic mutations in cerebral malformations: Somatic mutations are widely recognized in cancer, often affecting prognosis and determining candidacy for use of molecular targeted treatments. These somatic mutations may lead to a mosaic population of cells. Recent advances in technology involving deep next-generation sequencing have allowed for detection and quantification of these mosaic variants.

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Molecular tumor boards: fixture or fad?

October 2014—Along with everything else the genomics revolution has wrought, there’s this: Molecular testing is threatening to turn medicine into an ongoing episode of “Hoarders.” So much information and so many possible uses for it—including, in some cases, none at all. The expansion of molecular testing is also upending the role of the traditional tumor board.

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21 honored for patient care, strategy, safety, and service

October 2014—Stanley J. Robboy, MD, was presented Sept. 7 with the Pathologist of the Year award during an evening event at the CAP ’14 annual meeting in Chicago. At the same event, at the Hyatt Regency Chicago, Seema Sethi, MD, was honored as Resident of the Year, and Samir Sami Amr, MD, received the Pathology Advancement award. The CAP Foundation Gene and Jean Herbek Humanitarian award went to Barbarajean Magnani, PhD, MD, who was given a second award: the Distinguished Patient Care award.

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Put It on the Board, 9/14

September 2014—Simple blood tests, colossal contrasts on price: California hospitals have a pricing range for common blood tests so wide that it brings to mind the vast span of that state’s world wonder, the Golden Gate Bridge. Among the 150 hospitals whose blood test charges were examined in a recent study, the price for a basic metabolic test ranged from $35 to $7,303, depending on the hospital, with a median charge of $214. The biggest price difference was in charges for a lipid panel.

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Q & A Column, 9/14

September 2014—Occasionally on certain patients, when we draw for a CBC in the early morning, we get a low Hgb of 6 or 7 g/dL. We draw the same patient for a CBC in the afternoon and we get a higher Hgb by at least 1–1.5 g/dL. Can you explain the reason for this difference? We would like to standardize reference ranges throughout our system of regional facilities, using our main laboratory to establish the ranges. How does the CAP view using the transference process as described in CLSI document C28-A3C, Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline? Is this an approved method for establishing reference ranges? Is it an acceptable process once the laboratory director approves it?

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Newsbytes, 9/14

September 2014—Why LIS limitations shouldn’t inhibit genomic testing: Many community-based hospitals don’t have the resources to perform complex genomic testing, but they shouldn’t let that deter them. By being creative in overcoming the limitations of their lab information systems, pathology departments can ensure that clinicians and their patients benefit from the latest advances in next-generation sequencing, says Lynn Bry, MD, PhD.

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Anatomic Pathology Selected Abstracts, 9/14

September 2014—Cytokeratin 17: an adjunctive marker of invasion in anal squamous neoplastic lesions: Diagnosing anal squamous cell carcinoma, which is often preceded by anal intraepithelial neoplasia, may be challenging in small biopsies. Cytokeratin 17 (CK17) is a basal/myoepithelial cell keratin induced in activated keratinocytes and associated with disease progression in squamous cell carcinoma (SCC) of the uterine cervix, esophagus, and oral cavity.

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Clinical Pathology Selected Abstracts, 9/14

September 2014—Potential link between vitamin D and subclinical cerebrovascular disease: Vitamin D deficiency has been associated with several diseases, including hypertension, diabetes mellitus, and stroke. A recent prospective population-based study of cardiovascular disease showed that subclinical infarcts and white matter hyperintensities (WMHs) are commonly seen on brain magnetic resonance image scans of older adults and are associated with cardiovascular disease risk factors and prior stroke. The lesions are also associated with reduced functioning on cognitive tests.

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New push for standard approach to critical values

September 2014—Newly reported survey data that show widely varying international practices on managing critical values may demonstrate the need for a new guideline—already in development—to help laboratories formulate evidence-based policies. The new data from European labs were presented during a session at the American Association for Clinical Chemistry’s Annual Meeting and Clinical Expo in Chicago (“Critical Result Management Practices: Global Perspectives and Recommendations for Best Practices”). The session also provided a preview of a forthcoming draft guideline from the Clinical and Laboratory Standards Institute that represents the organization’s first formal attempt to advise laboratories around the world on critical values reporting.

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From the President’s Desk: Premium PT—and more to come in 2015, 9/14

September 2014—Even as a newly minted pathologist, I knew that the CAP Surveys were critical tools to ensure patient safety and test validity. Still, I didn’t give them much thought. There was already a lot to learn; something already so well established just wasn’t on my radar. But over time and with experience, I learned that our Surveys program of proficiency testing, which had its roots in a demonstrated need for interlaboratory comparison 60 years ago, had evolved organically into an engine of scientific advancement in our specialty.

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A laboratory on the trail of troubling TSH results

September 2014—It would be a nightmare for any laboratory professional: a misdiagnosed and mistreated patient owing to an aberrant test result. Julia C. Drees, PhD, a scientific director for chemistry at TPMG Regional Reference Laboratory, Kaiser Permanente Northern California, found herself facing that situation two years ago. She and colleague Judy Stone, PhD, then a Kaiser scientific director who is now at UCSD, discovered that faulty TSH results from their laboratory had led to multiple patients being misdiagnosed, and some even treated inappropriately.

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No surprises—one lab’s approach to costly genetic testing

September 2014—Medical practice is no stranger to good things coming from bad, but lest anyone be in doubt, Children’s Hospital and Medical Center in Omaha provides a striking example. The bad, in this case, was an exorbitant bill for genetic testing delivered several years ago to the parents of a sick child. The family had no idea such an expensive test had been ordered or that their insurance company would not pay for it.

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Risk management steps up labs’ QC game under IQCP

September 2014—Industrial risk management. It may not seem all that sexy as a concept, but in the field of laboratory quality control, risk management has become about as buzzworthy as is possible. One of the key reasons: The Centers for Medicare and Medicaid Services has embraced risk management as the foundation of a new option for meeting CLIA quality control standards called IQCP, or Individualized Quality Control Plan.

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Virus or bacterium? Gene expression may tell

September 2014—At the 30th Annual Clinical Virology Symposium this spring, Gregory Storch, MD, related a typical case of a febrile child seen in the emergency department. Dr. Storch, a professor of pediatrics at Washington University School of Medicine, described a 20-month-old boy with a fever of 40°C, rash, cough, and nasal congestion but no gastrointestinal symptoms. White blood cell count was 7,800/µL. Blood culture was negative and a chest x-ray showed mild peribranchial thickening. Diagnosis, Dr. Storch says, was “viral syndrome.” The patient got a dose of ceftriaxone, which was “reasonable,” in Dr. Storch’s view, in light of the patient’s fever and the presence of bands on the peripheral blood smear.

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Molecular Pathology Selected Abstracts, 8/14

August 2014—The dystrophin gene is the largest known human gene, comprising 2.2 Mb of the genome and 79 coding exons: Through the use of multiple tissue-specific promoters and alternative splicing of RNA, several isoforms of the protein dystrophin are encoded by the dystrophin (DMD) gene. The primary 427-kDA dystrophin isoform (Dp427) is found in the cytoplasm of skeletal and cardiac muscle cells, where it is involved in physically linking the cytoskeleton to protein structures outside the cell and, therefore, strengthens and protects muscle fibers during contraction and relaxation.

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From the President’s Desk: From representation to RUC, reasons to join AMA

August 2014—It was my good fortune to be introduced to practice by a group of pathologists with a tradition of robust professional engagement. In residency or shortly thereafter, all of us joined the CAP, our state pathology society, state medical society, and the AMA because we were brought to understand it was the right thing to do. Explicitly and by example, mentors and partners have taught me a lot.

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Latest lineup of chemistry analyzers for low-volume settings

August 2014—This year’s guide to chemistry analyzers for low-volume laboratories consists of information supplied by 17 companies on 33 analyzers, three of which are new to this guide. Vital Diagnostics, an ElitechGroup Company, launched the Eon 300 Clinical Chemistry system. The system is sold exclusively by McKesson Medical Surgical to small to midsize physician offices and satellite and hospital laboratories.

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Where smart labs go when the money’s gone

August 2014—Payment rates declining. Bad debt rising. Test orders falling. Diagnostic equipment manufacturers checking in on test-volume commitments. A wrenching transition from fee-for-service care to population-based medicine. These are a few of the trends that laboratories across the country are seeing and that keep lab directors up at night, heavy lidded, checking their email, illuminated by the glow of their smartphones.

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Study hints at new directions on LAMNs

August 2014—A slow leak in a tire may not be all that interesting— until one is cruising down the highway at 75 m.p.h. Suddenly, that same leak becomes much more compelling. Joseph Misdraji, MD, recalls a conversation he had at a meeting about pseudomyxoma peritonei that skirted a similar curve in the road. Approached by a pathologist who expressed a desire to collaborate with him, Dr. Misdraji suggested a study he was working on, looking at the significance of proximal margin involvement in low-grade appendiceal mucinous neoplasms, or LAMN.

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Seamless automation: within reach for AP?

August 2014—A familiar optical illusion uses a drawing of a vase that makes your eyes play tricks. First you see the vase, then two faces gazing at each other, then again, the vase…two faces…ad infinitum. It’s a concept that comes to mind when thinking about “tracking” in the anatomic pathology laboratory. Does it refer to a physical track—a conveyor belt to automatically transport and sort specimens—or to a system for “tracking”—that is, electronically keeping tabs on specimens?

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Too few studies to steer test protocols for pediatrics

August 2014—Are children equivalent to miniature adults? Common sense and years of research on age-related differences in microbiota, immune system development, and infectious disease susceptibility point to a resounding no. But in clinical microbiology practice, if not in theory, pediatric patients are too often worked up as miniature adults, says Jennifer Dien Bard, PhD, D(ABMM), FCCM, director of the clinical microbiology laboratory and acting director of the clinical virology laboratory at Children’s Hospital Los Angeles, and an assistant professor of clinical pathology at the University of Southern California’s Keck School of Medicine.

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Proposed prostate biopsy policy could cut Medicare pay

August 2014—How the Medicare program reimburses pathologists for prostate biopsy specimen services could change in 2015 under proposed rules for physician payment from the Centers for Medicare and Medicaid Services. The CMS detailed its proposed plans for prostate biopsy reimbursement, in addition to other payment policy changes concerning pathologists, in the proposed 2015 Medicare physician fee schedule released July 3. The proposal includes adding three new pathology measures, sponsored by the CAP, to the Medicare Physician Quality Reporting System and the expansion of CMS’ value-based modifier program. After a 60-day comment period, the CMS will finalize the 2015 fee schedule later this year.

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Evalumetrics—a performance measurement tool and more

August 2014—Change takes time. Ask anyone who’s ever joined a gym, coached an underperforming sports team, or felt themselves growing older—cell by graying, wrinkling cell—in the change-of-address line at the DMV. Or just ask Donald Karcher, MD. Since 2008, when the Joint Commission began mandating that health care organizations rigorously evaluate physician performance when granting or renewing practice privileges, Dr. Karcher has watched laboratories gradually move from noncompliance to curiosity to comprehension and finally to compliance.

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Cytopathology and More | The Pap test under fire

August 2014—The humble Pap test is perhaps one of the most lauded and disdained laboratory tests, lauded because it is the lab test with the best track record of preventing cancer and disdained because the test is labor-intensive, the results are operator dependent, and the regulations are burdensome. Recently the Pap test has come under fire, threatened to be replaced with HPV tests and maligned by patients and physicians for its sometimes unexpected high cost.

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Cytopathology and More | ATHENA design, data—and the FDA’s decision

August 2014—The Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory Committee held a hearing March 12 on a proposal by Roche Molecular Systems for a new application of human papillomavirus first-line primary cervical cancer screening for women age 25 and older. The 13-member panel unanimously approved the test as safe and effective with benefits to women’s health. The FDA formally approved the additional testing indication on April 24.

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Cytopathology and More | Pap proficiency testing—for whom, when, and why

August 2014—It has been almost 10 years since gynecologic cytology proficiency testing, or Pap PT, was implemented in the United States. The CAP is one of three organizations with a Pap proficiency testing program. Pap PT is unique in medicine. In no other situation are licensed physicians or certified technologists required to pass a federally mandated, annual proficiency test before they can practice a skill for which they were trained. Individuals who do not pass Pap PT after two tests cannot practice the interpretation of gynecologic cytopathology until they pass the test.

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Q & A Column, 8/14

August 2014—Is there a trough and crest occurrence with blood testosterone levels, or is it like thyroid testing, where one’s result is the total of the previous several days? What is the relationship between the presence of moderate to many spherocytes and the MCHC parameter? We always thought cases that show spherocytes on the blood smear are usually associated with high MCHC. We had a case of autoimmune hemolytic anemia with moderate spherocytes, but the MCHC was normal.

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Newsbytes, 8/14

August 2014—Smartphone use in AP ‘immature’ but advancing: It may never be as famous as Snapchat or Instagram, but another method of photo sharing is gaining favor with some anatomic pathologists by allowing them to use their smartphones to send images from glass slides quickly and inexpensively. “The use of smartphones is still at an immature stage for pathology, but I think the emerging area is utilizing the camera functions in the phones to manage decisionmaking,” says Douglas J. Hartman, MD, assistant professor, Department of Anatomic Pathology, University of Pittsburgh Medical Center.

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Anatomic Pathology Selected Abstracts, 8/14

August 2014—GATA3: a multispecific but potentially useful marker in surgical pathology: The transcription factor GATA3 is important for differentiating breast epithelia, urothelia, and subsets of T lymphocytes. It has been suggested that it may be useful in evaluating carcinomas of mammary or urothelial origin or metastatic carcinomas, but its distribution in normal and neoplastic tissues is incompletely mapped. The authors conducted a study in which they examined normal developing and adult tissues and 2,040 epithelial and 460 mesenchymal or neuroectodermal neoplasms for GATA3 expression to explore its diagnostic value in surgical pathology.

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Clinical Pathology Selected Abstracts, 8/14

August 2014—Anti-D alloimmunization after D-incompatible platelet transfusions: Because a small but immunogenic dose of red blood cells may be contained in apheresis platelets, transfusion services establish protocols to provide D– recipients with D– platelets to prevent anti-D alloimmunization. This is of particular concern for young females as there is potential for hemolytic disease of the newborn. In cases where D+ platelets are given to D– recipients, Rh immune globulin (RhIG) may be used to help prevent sensitization. The authors retrospectively analyzed during a 14-year period the anti-D formation in D– recipients who received D+ platelets without the use of RhIG.

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Cytopathology and More | Of confusion, cost, and communication

August 2014—In the days after my “Perspective” piece on the thousand-dollar Pap smear was published,1 I was profoundly moved by the number of physicians from diverse specialties and practice settings who reached out to tell me how important they believe issues of cost and cost transparency are to our ability to practice in the best interest of our patients. Barbara Crothers, DO, of the CAP Cytopathology Committee, was among those who reached out. I learned from Dr. Crothers and her colleagues that pathologists share the sense of frustration and loss of control that I often have as a primary care provider confronted by opaque ordering systems and skyrocketing costs for a simple, potentially life-saving test.

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New analyzers, assay applications, and tools, tests, and solutions to come

July 2014—In this year’s roundup of chemistry analyzers for mid- and high-volume laboratories, three appear in our guide for the first time. Randox received FDA clearance this year for the latest edition of its RX series, the RX Daytona Plus, a fully automated, random-access benchtop analyzer that’s capable of running 270 photometric tests per hour or 450 tests per hour with the optional ion selective electrode unit.

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AML molecular testing a map with many paths

July 2014—When it comes to molecular testing for acute myeloid leukemia, the approach seems more Montessori than military school. There are some basic steps physicians should take, to be sure. Cytogenetics still shepherds patients into three prognostic groups: favorable, intermediate, and unfavorable. And several gene mutations—NPM1, CEBPA, FLT3, and KIT—alone or in combination, and with various cytogenetic associations, provide additional prognostic and therapeutic guidance.

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Slashing send-out costs with lab formularies

July 2014—A glance at most hospital laboratory spreadsheet makes it clear: Where laboratories could reduce high-cost reference testing for inpatients and unreimbursed send-out testing for outpatients, the savings would be striking. But voluntary education programs geared to improving test ordering practices are known to have their limits. Could a mild form of, well, coercion be helpful?

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Lab gets a jump on pay-for-value world

July 2014—Before the Affordable Care Act was passed, and before the notion of an ACO became a Medicare reality, Richard J. Cote, MD, was among those in medicine who saw the writing on the wall regarding health care payment. Dr. Cote recalls his thinking as he joined the University of Miami Miller School of Medicine in 2009 to become chair of its Department of Pathology.

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PT referral rules bring regulatory relief for labs

July 2014—Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations.

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Clinical Pathology Selected Abstracts, 7/14

July 2014—Effects of fish oil in recent-onset rheumatoid arthritis: a patient study: The omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaneonic acid (DHA), which are found in fish oil, can suppress synthesis of the omega-6 proinflammatory eicosanoids prostaglandin E2 and leukotriene B4. The effects of fish oil as a dietary supplement in rheumatoid arthritis have been studied in randomized, controlled trials for patient-assessed pain, morning stiffness, number of painful or tender joints, and non-steroidal anti-inflammatory drug consumption.

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In amyloidosis, timely diagnoses lag therapy gains

July 2014—G-G-G-E♭. Also known as da-da-da-DUM. Also known as the opening to Beethoven’s Fifth Symphony. It’s a simple motif, heard repeatedly in the piece (not to mention across the centuries), yet no less thrilling for that fact. Maria M. Picken, MD, PhD, finds herself repeating an equally straightforward motif when she speaks about amyloidosis, and it, too, is worth hearing again: The disease is not being diagnosed early enough, and sometimes not at all. That theme has been a steady refrain of hers over the years, and it runs throughout a recent interview with CAP TODAY, so much so that she worries readers will respond with, Oh no, here she goes again.

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Anatomic Pathology Selected Abstracts, 7/14

July 2014—Assessing IHC biomarkers for basal-like breast cancer against a gene-expression profile gold standard: Gene-expression profiling of breast cancer delineates a particularly aggressive subtype referred to as basal-like. This subtype comprises approximately 15 percent of all breast cancers and afflicts younger women. It is refractory to endocrine and anti-HER2 therapies.

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Put It on the Board, 7/14

July 2014—Ethics of laboratory billing at stake in AMA’s code: Proposed revisions to the American Medical Association’s Code of Medical Ethics would remove language that supports direct billing and condemns clinicians who charge markups for laboratory or pathology services. The changes could weaken efforts to rein in billing practices that CAP leaders argue are not in the best interest of the patient and that the AMA currently defines as unethical.

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Newsbytes, 7/14

July 2014—The benefits of building versus buying lab software: Like many in the field of pathology informatics, John Sinard, MD, PhD, does not believe that one-size-fits-all when it comes to laboratory software systems. But unlike many of his peers, he does not choose to live with the discrepancies or purchase a new product.

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Data spark new directions in cervical cancer

June 2014—When Mark Stoler, MD, stood up to speak at the 30th annual Clinical Virology Symposium on April 29, his topic was timely. Dr. Stoler was presenting three-year followup data from the ATHENA trial, in which a primary human papillomavirus screening algorithm based on the Roche Cobas HPV assay was compared with traditional cytology and a hybrid cotesting algorithm for their ability to prevent cervical cancer.

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New analyzers, connectivity, tests, and software features

June 2014—Cleared in April by the FDA is Nova’s newest—the Stat Profile Prime, which features Zero maintenance cartridges and MicroSensor technology. The Zero maintenance cartridge technology consists of individual cartridges for biosensors, calibrators, and liquid QC. The design optimizes the life of each cartridge, improves analyzer uptime, and eliminates the waste, downtime, and higher costs associated with older systems, says Rick Rollins, Nova marketing specialist. Stat Profile Prime analyzers deliver a 10-test profile—pH, PCO2 , PO2 , Na, K, iCa, Cl, Hct, glucose, and lactate—in 60 seconds.

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Put it on the Board, 6/14

June 2014—For trainees, information ‘gaps are closing’: With the dismissal of residents from training programs having led to well-known tragedies, the most recent in pathology just a year ago, attention is being paid to the importance of ensuring residents’ well-being and properly handling remediation, probation, and dismissal.

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A question of capital: Will lab purchasing take a U-turn?

June 2014—If they made disaster movies about the laboratory industry, you could cue the voice talent right now, because all the plot elements seem ready at hand. In a world where an economy haltingly recovers from the blows of recession, a series of double-digit reimbursement cuts for laboratory services looms. New financial accounting standards lurk in the background, threatening to roil traditional equipment rental arrangements. A mammoth national health insurance program rolls out, generating fears of one set of dictates to rule them all.

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Cancer biomarker use varies widely, needs a ‘broader view’

June 2014—Despite an explosion of research into cancer biomarkers and professional guidelines that urge testing for certain genetic mutations that help detect disease, anticipate its course, or predict response to treatment, many cancer centers are out of sync with oncology testing recommendations. Payment policies, regulatory oversight, clinician preferences, and varying access to testing technology are among the factors that contribute to discrepancies in cancer care.

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Protecting Access to Medicare Act
CAP on rule to implement law: ‘We will be there’

June 2014—The CAP’s leaders say they will keep pushing for favorable pathology payment policies as federal regulators implement new legislation that could lead to steep cuts in Medicare rates. Six weeks before the May 5–7 CAP Policy Meeting in Washington, DC, Congress enacted the Protecting Access to Medicare Act of 2014. The bill, signed into law April 1, stopped cuts to physician services under the flawed Medicare sustainable growth rate formula used to calculate Medicare pay.

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NGS to detect oncogenes—sizing panels, reporting results

June 2014—Scientific wonders always abound at the Advances in Genome Biology and Technology conference, and this year’s meeting in February was no exception. Attendees had their first opportunity at a scientific meeting to learn about the newly announced Illumina HiSeq X Ten, a combination of 10 HiSeq X systems, which, Illumina says, can sequence 16 whole human genomes per three-day run at a read depth of 30× and a cost of $1,000 per genome. At the other end of the scale, attendees saw the unveiling of Oxford Nanopore’s MinION, a sequencer the size of a pack of chewing gum.

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Anatomic Pathology Selected Abstracts, 6/14

June 2014—Utility of triple antibody cocktail intraurothelial neoplasm-3 and AMACR in urothelial CIS and reactive urothelial atypia: Urothelial carcinoma in situ (CIS) is a prognostically and therapeutically significant lesion with considerable morphologic overlap with reactive conditions, especially in the setting of prior therapy. Various markers, including CK20, CD44s, and p53, have been used as an adjunct in making this distinction.

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Using molecular techniques to confirm donor-derived post-transplant lymphoproliferative disorder

June 2014—Post-transplantation lymphoprolif-erative disorders (PTLD) encompass a spectrum of neoplasms, ranging from benign hyperplasia to non-Hodgkin lymphoma and Hodgkin lymphoma. Epstein-Barr virus is postulated to play a key role in the pathogenesis of PTLD in patients who were previously EBV negative. This is a case report of a 52-year-old female, status post unrelated bone marrow transplant for myelofibrosis, who developed primary central nervous system diffuse large B-cell lymphoma, post-transplantation.

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microRNAs entice as diagnostic key to multiple diseases

June 2014—In research and development of diagnostics based on the small, non-coding RNAs known as microRNA, the potential clinical applications in cancer were the first to be explored and have hogged the spotlight. But the more light that is shed on micro­RNAs’ mysteries, the more promise microRNA shows as a diagnostic and therapeutic tool in an array of diseases beyond cancer.

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Clinical Pathology Selected Abstracts, 6/14

June 2014—How a single patient influenced HIV research: 15-year followup: The hope of a cure for human immunodeficiency virus infection is raised by recent reports of people in whom viral replication spontaneously reduced despite the absence of antiretroviral treatment (ART). A “Berlin patient” described in 1999 was immediately treated with ART and hydroxyurea after an acute HIV infection but chose to discontinue treatment.

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Newsbytes, 6/14

June 2014—Making the most of big data no easy task: A trillion base pairs of sequence here, a trillion there. Pretty soon, you’re talking about a lot of information—and it all needs to be managed. That’s the dilemma facing Mayo Clinic and other health care organizations leading the personalized medicine revolution that relies on compiling and analyzing patients’ genetic code to better diagnose, predict, and treat disease.

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Q & A Column, 6/14

June 2014—Treatment with rasburicase seems to affect the uric acid analysis. Drawing the specimen in a pre-chilled lithium heparin tube appears to eliminate the falsely low uric acid results we see. Are there current studies regarding uric acid test analysis on patients receiving rasburicase?

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Cytopathology and More | Cytopathology at the tipping point

May 2014—A tipping point implies a point of no return, a monumental change in the status quo, a transformation that leads to a new paradigm. Malcolm Gladwell, in The Tipping Point: How Little Things Can Make a Big Difference, popularized the term and defined it as “the moment of critical mass, the threshold, the boiling point.” Tipping points bring both positive and negative consequences; they are a time of change and opportunity. Such is the position that cytopathology finds itself in today.

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Cytopathology and More | Cytopathology letter: Ignoring recommendations?

May 2014—Recently I received the 2014 CAP PAPM-A (gynecologic pathology) slide set and was surprised to see case No. 5: a Pap test from an 82-year-old woman with a clinical history of “routine exam.” The cervical cancer screening recommendations from the U.S. Preventive Services Task Force recommend against screening women over the age of 65 who have had adequate prior screening and are not at high risk for cervical cancer, while the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology guidelines recommend no screening for women over age 65 with evidence of adequate negative prior screening and no history of CIN2+ within the past 20 years.

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Pressure’s on to halt nosocomial infections

May 2014—Modern health care is more advanced than ever, but institutions continue to battle one problem that refuses to go away: hospital-acquired infections. They should be preventable, yet a recent CDC report estimates that one in 25 U.S. patients acquired at least one infection during a hospital stay in 2011. The most pervasive nosocomial pathogens, by far, are Clostridium difficile and Staphylococcus aureus.

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Molecular assays in HIV-1 Dx and therapeutic monitoring

May 2014—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. Here, this month, is the fourth such case. (See the February, August, and September 2013 issues for the first three.) AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, treatment, and more. Case report No. 4 comes from the Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania.

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Cytopathology and More | FNA cytology: Rapid on-site evaluation—how practice varies

May 2014—Rapid on-site evaluation, or ROSE, is a service that pathologists and cytotechnologists commonly perform to check the cellular content and adequacy of fine-needle aspiration smears and biopsy touch imprints. ROSE can inform the operator of the need to obtain additional samples and, in this cost-conscious age, make it possible to avoid having to repeat the procedure. ROSE allows for preliminary diagnosis so that additional material can be requested for ancillary studies such as flow cytometry, microbiology cultures, or molecular studies.

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Put It on the Board, 5/14

May 2014—FDA clears FilmArray GI Panel: BioMérieux affiliate BioFire received Food and Drug Administration 510(k) clearance for the FilmArray Gastrointestinal Panel. The 22-target panel allows a syndromic approach to the diagnosis of infectious diarrhea, the company says, as it includes bacteria, viruses, and parasites in one test.

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Q & A Column, 5/14

May 2014—Checklist requirement HEM.23050 regarding reference intervals includes a note that if absolute cell counts are reported with their reference ranges, then percent cell count reference ranges should not be reported because they can lead to misinterpretation of CBC data. I understand that many laboratories, like ours, have been reporting reference ranges for both absolute and percent cell counts, and I would like to clarify whether this is permissible.

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Newsbytes, 5/14

May 2014—How to avoid becoming a ‘legacy system junkyard: The constant churn of information technology applications is creating new security and financial risks that health care organizations—including laboratories—must systematically address, IT experts say.

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Clinical Pathology Selected Abstracts, 5/14

May 2014—Real-time clinical decision support systems for platelet and cryoprecipitate orders: Platelet and cryoprecipitate transfusions are often used to treat patients who are bleeding. However, many clinicians use non-evidence–based approaches to ordering and transfusing these products. Cost and such adverse effects as transfusion-transmitted diseases and transfusion reactions make it desirable to reduce the unnecessary transfusion of these products.

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Anatomic Pathology Selected Abstracts, 5/14

May 2014—Impact of operator techniques and specimen-preparation checklist on bone marrow assessment: Successful bone marrow assessment is essential to the diagnosis and staging of hematologic malignancies. The authors conducted a study to determine whether specific operator techniques or use of a specimen-preparation checklist, or both, could impact the quality of bone marrow assessment by reducing the frequency of obtaining nonspicular aspirates, small cores, and nondiagnostic samples.

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Letters, 4/14

April 2014—HER2 testing guideline update: Karen Titus’ article “New guideline takes on tough HER2 cases” (October 2013) nicely captures the deliberations behind the new HER2 testing guideline, issued by the American Society of Clinical Oncology and the CAP last October. But as her article makes clear, the new guideline leaves open a question—and I would like to suggest an answer. That answer is based on new studies of molecular diagnostics, to which my institution and several others are contributors, and my own experience as a practicing medical oncologist.

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Put It on the Board

April 2014—Clinical trial data and a Food and Drug Administration panel’s full-throated endorsement stand to reshape cervical cancer screening practice recommendations in the U.S. The FDA’s Microbiology Devices Advisory Committee in March voted 13-0 in favor of a new indication for Roche’s Cobas human papillomavirus test that would allow the assay to be used as a primary screen for cervical cancer in women 25 and older.

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Taking aim at overuse: daily labs, high-cost send-outs

April 2014—As reimbursement models change, achieving better test utilization will become a survival strategy. And in the hard work to improve test use, the computerized physician order-entry system appears to be the work tool with the winning record. Inpatient laboratory tests at Massachusetts General Hospital fell by 21 percent between 2002 and 2007, despite a seven percent increase in the number of discharges. Per discharge, inpatient tests dropped by 26 percent (Kim JY, et al. Am J Clin Pathol. 2011;135:108–118). Kent B. Lewandrowski, MD, associate chief of pathology and director of laboratory and molecular medicine at MGH and professor of pathology at Harvard Medical School, calls the number of inpatient tests per discharge “a global benchmark,” saying, “It rolls up all of our individual utilization initiatives.”

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Pens, pencils, Post-its—setting out to save on supplies

April 2014—The Department of Laboratory Medicine and Pathology is one of the largest departments at Mayo Clinic, with approximately 3,250 employees who work in 61 specialty labs at seven locations across Rochester, Minn. Throughout this large department, about 300 employees are designated to order supplies for their work units, which consist of laboratory and support staff. Before 2008, there was no standard process for ordering office supplies, which led to inefficient practices and escalating costs over time.

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HPV primary screening for cervical cancer—an interview with Ritu Nayar, MD

April 2014—Dr. Nayar, professor of pathology at Northwestern University Feinberg School of Medicine in Chicago, is co-chair of the Cytopathology Education and Technology Consortium, president of the American Society of Cytopathology, and a member of the CAP Cytopathology Committee. She spoke with CAP TODAY recently about the FDA advisory committee’s recommendation on cervical cancer screening.

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Microbiology automation: finding the right mix

April 2014—Talk to a few microbiology laboratories about why they feel the need to automate and you hear common themes: people, space, quality, and, most of all, time to detection. Microbiology may be late to join the bandwagon, but whether laboratories are making partial or full-scale moves to automate, they are dramatically making up for lost time, in all senses of the phrase. That’s because turnaround time savings are no longer measured in minutes. “Our goal is to be able to give some of these answers out in one to four hours rather than 24 hours, or much longer for some culture-based methods,” says Randall T. Hayden, MD, director of clinical and molecular microbiology at St. Jude Children’s Hospital in Memphis.

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Can an old drug be taught new pharmacogenetic tricks?

April 2014—Despite warfarin’s continued presence near the top of the FDA’s list of adverse drug events and the availability of competing agents, the drug continues to be a mainstay of anticoagulant therapy, particularly among general practitioners. Its narrow therapeutic window and intra- and interpatient variability require regular measurement of the international normalized ratio. This, along with the large genetic component to warfarin response, principally contributed by variants in the genes VKORC1 (–1639G ➞ A) and CYP2C9 (*2 and *3), led many to hypothesize that pharmacogenetics could improve warfarin safety.

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In encephalitis case, next-gen sequencing is the star

April 2014—In what may be a first for the burgeoning field of next-generation sequencing, this powerful new technology was used to identify the cause of encephalitis in a teenage boy who had been critically ill in the intensive care unit for several weeks. Diagnosis suggested a specific treatment. Within two weeks of initiating therapy, the boy had recovered and was discharged. It is becoming common practice to use NGS to detect mutations that can help select drug therapy in cancer cases and to find genetic variations responsible for inherited diseases. However, NGS has not previously been considered a useful tool in critical care situations, where a short turnaround time is crucial.

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Tuning in to hypotensive transfusion reactions

April 2014—Most pathologists are trained to think of hypotensive transfusion reactions as rare events, and for the most part they are. But one pathologist’s experience suggests these reactions may be underreported, and perhaps on the rise. Greater recognition of these events could provide valuable information and help improve patient outcomes. “People often report these reactions as possibly related to transfusions, but the challenge to the pathologist is that the transfusion reaction workups are negative, for the most part. So they’re in a quandary as to whether the drop in blood pressure was because of the transfusion or other causes,” says Richard M. Scanlan, MD, clinical professor, vice chair of laboratory medicine, and director of the transfusion medicine service at Oregon Health and Science University (OHSU).

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From the President’s Desk: Member survey meets our need to know, 4/14

April 2014—Soon CAP members will receive the online Practice Characteristics Survey, designed to provide evidence of the value we contribute to health care and the many ways we serve our patients. This is the ninth time since 1994 that we have conducted this survey, which informs our policy, advocacy, and planning for member services. If every CAP member makes a commitment to complete and return the survey, the results will greatly refine and enlighten our work to serve, promote, and represent your best interests. But every is the key word. Each member has a role in building a robust response rate that will give our findings the depth and level of credibility that inform and educate.

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A lot to like about laboratory-provider links software

April 2014—It’s not a race, but you gotta keep pace or risk losing face (and customers and revenue). While this rhyme isn’t an axiom, for vendors of laboratory-provider linking software, it might as well be. “It seems like a new health care initiative, best practice, or regulation is announced every year,” says Tim Kowalski, president and CEO of Halfpenny Technologies. “That makes it crucial to choose laboratory vendor partnerships and solutions that are designed to withstand this ever-changing industry.”

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Q & A Column, 4/14

April 2014—I have a question about the meaning of the word “guideline” versus “procedure.” Checklist requirement ANP. 11670 Specimen—Gross Examination says the following: “Documented instructions or guidelines are readily available in the laboratory for the proper dissection, description, and histologic sampling of various specimen types (e.g. mastectomy, colectomy, hysterectomy, renal biopsy, etc.).” This leads me to question whether the word guideline means the same as procedure. Procedures need to be signed bi­ennially. Does the same apply to guidelines? The formatting is different for procedures. Could guidelines also mean references?

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Newsbytes, 4/14

April 2014—CommonWell executing pilot phase of interoperability project: Competition is considered a positive force in business, but when patients are the consumers, cooperation sometimes trumps competition. For the founding members of the CommonWell Health Alliance, all major players in the competitive arena of health information technology, enabling clients to share patient data across disparate care settings and competing electronic health record systems is viewed as a common-sense move that boosts cost-effectiveness and benefits patients.

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Clinical Pathology Selected Abstracts, 4/14

April 2014—Intervention to improve timing of vancomycin levels: Samples drawn for therapeutic drug monitoring are sometimes drawn too early, which can cause inaccurate results that lead to a potential dosing error. One approach to reducing such errors is to create an information technology tool to assist clinicians in determining the best timing for a sample draw. The authors conducted a study at Brigham and Women’s Hospital, Boston, in which the investigators used both an educational and electronic intervention to reduce the number of vancomycin collection timing errors. The information technology-based intervention provided educational instructions to nurses.

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Anatomic Pathology Selected Abstracts, 4/14

April 2014—Clear cell papillary renal cell carcinoma: diagnosis and immunohistochemical profile: Clear cell papillary renal cell carcinoma is a recently recognized renal neoplasm composed of cells with clear cytoplasm lining cystic, tubular, and papillary structures. These tumors have immunohistochemical and genetic profiles distinct from clear cell renal cell carcinoma and papillary renal cell carcinoma. The authors studied morphologic and immunohistochemical features (cytokeratin 7 [CK7], carbonic anhydrase IX [CAIX], CD10, alpha-methylacyl-CoA racemase [AMACR], smooth muscle actin, desmin, and estrogen and progesterone receptors) in 55 tumors from 34 patients, eight of whom had end-stage renal disease.

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Newsbytes, 3/14

March 2014—Digital imaging going strong but weaknesses persist: In his CAP ’13 presentation on digital imaging last fall, John H. Sinard, MD, PhD, asked attendees if they use digital still photography in anatomic pathology. “Most of the people in the room raised their hands,” says Dr. Sinard, who is professor of pathology, director of pathology informatics, and associate director of anatomic pathology at the Yale School of Medicine. In contrast, “very few hands went up” in response to a similar query regarding whole slide imaging.

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Laboratory automation possibilities give lift to labs

March 2014—Tracks, modules, rules, consolidations, connections. Marketers of lab automation systems and workcells are busy turning out and fine-tuning what labs of all sizes need in the face of staff shortages, belt-tightening, growing workloads, and the need to implement a new set of best practices as payment shifts from volume-based to value-based. “Automation systems that provide answers to these challenges will help fulfill the original promise of laboratory automation and become the new standards of automation innovation,” says Jeremy Kiger, marketing manager for lab automation and IT, Roche Diagnostics.

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Clinical Pathology Selected Abstracts, 3/14

March 2014—Transfusion-associated hyperkalemic cardiac arrest in pediatric patients: Hyperkalemic cardiac arrest is a potential complication in pediatric patients undergoing rapid massive transfusion. Identifying patients at particular risk for this reaction is critical for determining the best strategies to prevent transfusion-associated hyperkalemic cardiac arrest (TAHCA). Concerns arise over the use of older blood in at-risk pediatric patients. The authors examined the case reports and studies related to transfusion-associated cardiac arrest in a pediatric population.

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MicroRNA markers show staying power

March 2014—Not many components of human cell biology have been discovered and immediately dubbed “junk.” But micro-RNAs, small noncoding RNA molecules first identified in 1993, fall into that category. Like Hans Christian Andersen’s Ugly Duckling, microRNAs began their life after discovery with people scoffing at them. People even laughed at researchers who thought microRNAs held promise in diagnosing cancer.

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How a Maryland lab met fixed-budget test

March 2014—Maryland may be one of the smallest states in the nation, but its new effort to reduce spending on hospital services could have a big impact on patient care and health care costs. In January, after a three-year, 10-site pilot program, most of the state’s hospitals decided to move to a system under which “the hospitals are given a fixed budget and asked to manage the care of the patients they serve within that budget,” says Maryland Hospital Association president and CEO Carmela Coyle.

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Anatomic Pathology Selected Abstracts, 3/14

March 2014—Use of morphological parameters of LN in stereotactic 11-gauge vacuum-assisted needle core biopsy: Management of lobular in situ neoplasia when diagnosed on core biopsy remains controversial. The authors conducted a study to investigate the association between morphological parameters of lobular in situ neoplasia (LN) on vacuum-assisted needle core biopsy (VANCB) and the presence of malignancy (ductal carcinoma in situ, pleomorphic lobular carcinoma in situ, or invasive carcinoma) at surgical excision. The study included 14 pathology departments in Italy.

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How high-tech approach may reshape the autopsy

March 2014—Boosters of so-called virtual autopsy say it has the potential to revolutionize the practice of forensic pathology and could help increase the share of U.S. deaths subject to medical autopsy. The technique involves the use of computed tomography, magnetic resonance imaging, and three-dimensional surface scanning technology to help resolve tricky forensic questions such as whether a woman was killed with a hammer or a bicycle wrench.

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Put It on the Board, 3/14

March 2014—Patient-access rule creates opportunities, costs for labs: A long-awaited Department of Health and Human Services rule that requires laboratories to provide completed test reports to patients upon request may strengthen the relationship patients have with their pathologists, but also will pose another compliance burden for labs in many states.

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Put It on the Board, 2/14

February 2014—When are genomic tests useful? IOM seeks answers: Collaboration among key stakeholders to set clear evidentiary standards is needed to determine the clinical utility of genome-based testing in cancer care, according to a wide variety of experts participating in an Institute of Medicine workshop. Between 1969 and 1989, genomic biomarkers were mentioned in fewer than 50,000 National Library of Medicine publications. But between 2000 and 2010, more than 250,000 articles mentioned biomarkers, said a December 2013 IOM report, “Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary.”

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Breast cancer answers, short and long

February 2014—When it comes to breast cancer, medical oncologists have two “wish lists” for their pathologist colleagues. Here’s the short list of test results they need when they sit down with a patient, courtesy of Melody Cobleigh, MD. “ER, PR, HER2,” says Dr. Cobleigh, professor of medicine and the Brian Piccolo Chair for Cancer Research, Rush University Medical Center, Chicago. It’s a direct, unassailable answer. But so, too, is saying that the assassination of the Archduke Ferdinand caused World War I.

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Diabetes debate: HbA1c or glucose?

February 2014—If it were a boxing match, the debate over whether hemoglobin should be used to diagnose diabetes would place the odds-on favorite in the “Yes” corner. In the “No” corner would be the underdog. At least based on the mainstream consensus since 2010, HbA1c for diagnosis is well established as an alternative to measuring glucose.

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Powering down on excessive test use

February 2014—Utility companies can generate electricity in many ways—fossil fuel, nuclear reaction, solar panel, wind turbine. Which power source is preferable depends on the circumstances and the work that needs to be done. Generating optimal laboratory utilization is much the same. Providing an efficient and effective combination of tests for diagnosing hematologic neoplasms requires a different approach from achieving appropriate repeat ordering of chemistry tests in ICU patients. Delivering only the necessary blood components to cardiovascular surgery patients may take different tactics from curbing orders of expensive molecular genetic send-out tests.

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Handling a reagent recall, step by strenuous step

February 2014—Recalling a reagent is about more than just removing a product from laboratory shelves. It’s about retracting test results and thus affecting diagnoses and treatment plans. It’s about questioning patient outcomes and revisiting past decisions. “So much of what laboratories do is central to making a diagnosis and determining treatment,” says John Harbour, MD, regional medical director of HealthPartners Laboratories, medical director of the Bon Secours St. Mary’s Hospital Laboratory, and president of Monument Pathologists Inc., Richmond, Va.

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IT drives clinical, financial gains in hospital labs

February 2014—For “quants”—people who love all things numeric or algorithmic—information technology is its own reason for being. But for those with responsibility for clinical outcomes and the bottom line in the clinical laboratory, IT is much, much more. Innovative uses of IT are providing myriad new solutions with measurable paybacks in quality improvement and cost reduction.

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2013 statement on human papillomavirus DNA test utilization

February 2014—The Cytopathology Education and Technology Consortium in 2009 issued a statement on human papillomavirus DNA test utilization that was published in multiple journals. This statement was a concise summary of the clinical indications for high-risk or oncogenic HPV testing based on guidelines of the American Society for Colposcopy and Cervical Pathology and the American Cancer Society published from 2002 through 2007. These organizations have since published newer consensus guidelines addressing HPV testing, and the previous summary no longer reflects current screening and management guidelines.

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Testing the test—ABP administers pilot part 3 MOC exam

February 2014—All primary and subspecialty certificates that the American Board of Pathology issues are now time limited, and diplomates must successfully participate in the ABP’s Maintenance of Certification, or MOC, program to maintain certification. Part three of the four-part MOC program is the evaluation of cognitive expertise, which consists of a secure examination that assesses a diplomate’s pathology-specific knowledge, judgment, and skills.

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Clinical Pathology Selected Abstracts, 2/14

February 2014—Comorbidity-adjusted life expectancy: a new tool to aid cancer screening strategies: Controversy surrounds how best to use cancer screening tests in the elderly and at what age to stop screening. The benefits of early cancer diagnosis and treatment decline with age because many elderly people are more likely to die of a comorbid condition or other cause than of cancer. This impacts the survival benefits of early cancer detection. One must also consider the harms of screening, including complications of further testing and treatment for a disease that may not be symptomatic in a patient’s lifetime.

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Anatomic Pathology Selected Abstracts, 2/14

February 2014—Early stage triple-negative breast cancer treated with mastectomy without adjuvant radiotherapy; Predicting recurrence after limited resection versus lobectomy for small lung adenocarcinoma; HER2 amplification in gastric cancer: a rare event restricted to intestinal phenotype; Gleason score undergrading on biopsy sample of prostate cancer; Fallopian tube intraluminal tumor spread from noninvasive precursor lesions; Factors that influence histopathological diagnosis of differentiated vulvar intraepithelial neoplasia; Impact of molecular analysis on final sarcoma diagnosis; Distinguishing primary bladder adenocarcinoma from secondary involvement by colorectal adenocarcinoma; Determining if close margins warrant postoperative adjuvant radiotherapy in oral squamous cell carcinoma; Three methodological approaches for defining basal-like lesions in triple-negative breast carcinoma

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Q & A Column, 2/14

February 2014—We are thinking about using a reference laboratory for HER2 FISH testing of breast carcinomas with an arrangement in which that lab performs the technical component and we perform the interpretation. A “frequently asked question” from 2011 on the CAP Web site seems to say that we must perform bright-field ISH proficiency testing to be in compliance, since we are not performing the hybridization and cannot refer PT to another laboratory. Can you clarify the PT requirement, if any, for this situation? The vendor we are dealing with has offered to establish its own FISH PT program.

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Newsbytes, 2/14

February 2014—Orchard Software collaborates with Memorial Sloan-Kettering: Orchard Software has entered into a long-term agreement with Memorial Sloan-Kettering Cancer Center under which Orchard will supply the cancer center with its Orchard Harvest lab information system while working with Memorial Sloan-Kettering to enhance and further develop its lab informatics products.

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Cytopathology and More | Effectiveness of the HPV vaccine in Australia

January 2014—A school-based quadrivalent human papillomavirus vaccine program was introduced in Australia in April 2007 for 12- to 13-year-old girls. This program was also extended to 14- to 17-year-old girls in schools and to 18- to 26-year-old women in the community. The vaccination program has been highly successful, with uptake rates of 86 percent, 82 percent, and 75 percent for doses one, two, and three, respectively. Australia also has an established National Cervical Screening Program. Screening is recommended at age 18, or two years after the onset of sexual activity.

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Coagulation analyzers:
New analyzers, assays, controls, and PEP

January 2014—With the new year come fresh offerings from coagulation analyzer manufacturers, of which at least two have launched entirely new testing systems. Instrumentation Laboratory’s ACL AcuStar hemostasis system has been “met with great enthusiasm for its speed, accuracy, and comprehensive line of high performance chemiluminescent assays,” says Venita C. Shirley, director of marketing for commercial operations in North America.

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Introducing patients to their pathology reports

January 2014—Meaningful use standards are fostering increasing patient access to medical records, including pathology reports. Yet pathology reports can be challenging even for clinicians, much less for patients, to understand. Nonetheless, it is typically left to the treating non-pathologist clinician to explain the findings to the patient, even when the clinician lacks detailed knowledge of pathologic features.

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Anatomic Pathology Selected Abstracts, 1/14

January 2014—Flat pattern of nephrogenic adenoma unveiled using PAX2 and PAX8 immunohistochemistry; Managing borderline atypical ductal hyperplasia/ductal carcinoma in situ on breast needle core biopsy; Classic lobular neoplasia on core biopsy: a clinical and radiopathologic study with followup excision biopsy; Intestinal-type endocervical adenocarcinoma in situ: a subset of AIS affecting older women; Oncotype DX recurrence score: use of pathology-generated equations from linear regression analysis; Neuroendocrine carcinoma of the stomach: characteristics and prognosis; Interobserver reproducibility in diagnosis of high-grade endometrial carcinoma; Features associated with metastatic potential in invasive adenocarcinomas of the lung

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Clinical Pathology Selected Abstracts, 1/14

January 2014—Predictive factors for blood transfusion in living donor pediatric liver transplantation: Patients undergoing liver transplantation, in particular pediatric liver transplantation, may receive massive transfusion. However, technical surgical improvements over the years have made it possible for many patients undergoing pediatric living donor liver transplantation (LDLT) to avoid transfusion.

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Lab’s respiratory panel found to curb antibiotic use

January 2014—Fewer children with respiratory disease symptoms hospitalized from the ED without a diagnosis, less antibiotic use, and a favorable ratio of reimbursement to expense. That’s what the laboratory at Children’s Healthcare of Atlanta is seeing, said Beverly B. Rogers, MD, chief of pathology, in a Nov. 5 webinar, “Focus on FilmArray: One New Technology Applied to Classic Clinical Problems.” Presented by CAP TODAY and made possible by an educational grant from BioFire Diagnostics, the webinar centered on the multiplex PCR system from BioFire that tests for viruses, bacteria, yeast, and antimicrobial resistance genes.

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Labs weighing pros, cons of micro TLA

January 2014—Sleek specimen processing instruments, often with sophisticated robotics, are features of many larger microbiology laboratories, despite the longstanding belief that microbiology is too complex to automate. But total laboratory automation (TLA) has not yet gained a foothold in the U.S., even though there are several installations in microbiology laboratories in Europe. Could 2014 be the year that total microbiology laboratory automation comes into its own?

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The perils of overlooking lesser-known STIs

January 2014—When it comes to sexually transmitted infections, most clinicians and laboratories are well versed in diagnosing those caused by chlamydia, gonorrhea, HIV, and syphilis. But a host of lesser-known STIs often go undiagnosed, despite their surprising prevalence. Many of these STIs receive little publicity because they’re not considered reportable by the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists—a requirement that depends on a variety of factors, including whether an intervention is available and a public health response is indicated, and whether the disease or condition represents a threat to public health.

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