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2017 Issues

Hopes, fears as users switch to new troponin

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

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In hemostasis, two hot-button testing issues

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

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‘Connectathon’ opens door to interoperability in digital pathology

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

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HbA1c shows its mettle in predicting diabetes risk

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

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From the President’s Desk: Family matters, 12/17

December 2017—Most of us look forward to the holidays. We are excited about renewing old connections or making new ones, getting together with family and friends, having special meals, attending comforting services, gathering together to exchange gifts or just talk. We look forward to the comforts of predictability. The corny Dad jokes that must be retold. Family stories, those true and nearly true, are relived together and, for the younger members of the family, may be heard for the first time. Familiar, treasured television shows are seen for the umpteenth time. Beautiful lights, shows, pageants, and parades dazzle all, young and old.

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Higher pay for therapeutic apheresis, bone marrow aspiration

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

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

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

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Class act in Ohio expands pool of phlebotomists

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

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Anatomic Pathology Abstracts, 12/17

December 2017—Gene mutations in HPV-negative penile squamous cell carcinoma: The majority of penile squamous cell carcinomas are caused by transforming human papillomavirus infection. The etiology of HPV-negative cancers is unclear, but TP53 mutations have been implicated. Archival tissue from 108 invasive squamous cell carcinomas from a single pathology institution in a low-incidence area were analyzed for HPV-DNA and p16INK4A overexpression and for TP53 mutations by Ion Torrent next-generation sequencing.

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Clinical Pathology Abstracts, 12/17

December 2017—Chimeric antigen receptor T-cell therapy assessment and management of toxicities: In August, the FDA approved the gene therapy Kymriah (tisagenlecleucel) for pediatric and young adult patients with a form of acute lymphoblastic leukemia. Chimeric antigen receptor (CAR) T-cell therapy is a breakthrough in the treatment of leukemia and lymphoma, but it is associated with unique acute toxicities, such as cytokine-release syndrome and CAR-T-cell-related encephalopathy syndrome.

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Molecular Pathology Abstracts, 12/17

December 2017—Refining subgroups of pediatric gliomas using molecular markers: Pediatric high-grade and diffuse intrinsic pontine gliomas are a rare and heterogeneous group of tumors that show diverse histology, location, and prognosis. Although little was known regarding the development of these tumors, recent genomic studies have begun to elucidate their biological underpinnings. The authors conducted a study to further understanding of such gliomas by breaking them into subgroups.

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Newsbytes, 12/17

December 2017—Hospital cyberattack a brief setback with lasting gain: A cyberattack that paralyzed the computer systems at a rural West Virginia hospital last summer could have brought the laboratory’s work to a screeching halt. But that didn’t happen, thanks, in part, to the downtime procedures in place throughout the laboratory and the low-tech nature of the lab’s pathology operations.

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Put It on the Board, 12/17

December 2017—FDA announces IMPACT authorization and path for authorization of other tumor profiling tests: The FDA on Nov. 15 authorized Memorial Sloan Kettering Cancer Center’s IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets) tumor profiling test. The IMPACT test uses next-generation sequencing to identify the presence of mutations in 468 unique genes, as well as other molecular changes in the genomic makeup of a tumor.

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

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

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Benefits and bumps of shifting to Beaker

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

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LIS niche modules flourish amid IT consolidation

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

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With syphilis rates rising sharply, syphilis tests a focus

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

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From the President’s Desk: CAP17—No match for being there, 11/17

November 2017—My sister Jean had a Chatty Cathy doll; you pulled a cord in the back of her neck and she would say one of a handful of things (“Would you like some tea?”). Chatty Cathy was Jean’s favorite for a while, supplanting her much-loved Raggedy Ann. The coup lasted just long enough to make it plain that the new kid on the block didn’t have much to say for herself. She was kind of stiff and controlling, really. Raggedy Ann was a much better listener. Making up stories with her was a lot more fun.

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AMP case report: Follicular lymphoma of gallbladder, November 2017

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

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Clinical Pathology Abstracts, 11/17

November 2017—Performance of virological testing for early infant diagnosis: a systematic review: The World Health Organization recommends that HIV-exposed infants receive virological testing for HIV infection between four and six weeks of age and treatment with antiretroviral (ARV) therapy as soon as the diagnosis is made. Despite efforts to expand mother-to-child transmission prevention programs, only an estimated 50 percent of HIV-exposed infants are tested within the first two months of life.

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Newsbytes, 11/17

November 2017—Software-validation products: finding a glitch before it’s a hitch: The idiom “time is of the essence” isn’t lost on Lisa Adams, senior information technology systems analyst at Banner Health and a believer in the need for speed when identifying software glitches and errors.

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Q&A column, 11/17

November 2017—A laboratory owns chemistry analyzers from company X. Company X recommends that its customers use company X’s calibration material to perform their linearity studies, starting with the highest concentration and using the chemistry analyzer’s autodilution feature to provide a total of four measurable concentrations and a final zero point. Does this protocol fulfill CAP checklist requirements?

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Put It on the Board, 11/17

November 2017—Study finds biotin interference; FDA clears Flu A/B/RSV assay on Hologic’s Panther Fusion; FDA clears Abbott’s Alinity ci-series; Sysmex introduces CyFlow Antibodies for flow cytometry; Test approved for screening Zika in blood donations; New insights into female reproductive tract development

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Letters, 11/17

Biotin pharmacokinetic study results: In Anne Paxton’s September 2016 article, “Beauty fad’s ugly downside: test interference,” I stated a commitment from Roche to reduce possible interferences, including biotin, and provide clear test labeling to ensure that physicians and laboratories can mitigate risk.

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‘Split’ decisions in CNS tumor update

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

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Revived hopes, fresh challenges with liquid biopsy

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

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

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

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How to spot the savings from a diagnostic team

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

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Recommendations for investigating liver chemistry abnormalities are unworkable

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

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DIY or Survey? Identifying interfering substances

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

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

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

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

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

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Clinical Pathology Abstracts, 10/17

October 2017—Association between age at natural menopause and risk of type 2 diabetes: Menopause in women marks the loss of ovarian follicle development and the timing of the final menstrual period. The timing of menopause differs significantly among women and is seen as a marker of aging and cardiovascular health. Studies have shown a link between early onset of menopause and an increased risk of cardiovascular disease (CVD) and overall mortality, whereas menopause at age 50 to 54 years is linked to a decrease in CVD risk and mortality.

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Anatomic Pathology Abstracts, 10/17

October 2017—Lymph node yield is an independent predictor of survival in rectal cancer: Lymph node yield is used as a marker of adequate oncological resection. The American Joint Committee on Cancer recommends at least 12 nodes to confirm node-negative disease for rectal cancer. However, it is not always possible to achieve a lymph node yield of 12, particularly in patients who have undergone neoadjuvant treatment.

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Molecular Pathology Abstracts, 10/17

Editors: Donna E. Hansel, MD, PhD, chief, Division of Anatomic Pathology, and professor, Department of Pathology, University of California, San Diego; John A. Thorson, MD, PhD, associate professor of pathology, director of the Clinical Genomics Laboratory, Center for Advanced Laboratory Medicine, UCSD; Sarah S. Murray, PhD, associate professor, Department of Pathology, and director of genomic technologies, Center for Advanced Laboratory ...

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Q&A column, 10/17

October 2017—Our doctors request strep group A culture on throat specimens that are negative for rapid strep group A. On culture workup, if we have beta-hemolytic strep, we perform latex grouping only for group A strep; we report negative for GAS if latex is negative and positive if latex is positive. I think we should confirm all GAS with pyrrolidonyl arylamidase (PYR), and group and report other non-GAS. What do you think?

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Newsbytes, 10/17

October 2017—Clinical analytics: from benefits attained to software available: While LIS and laboratory billing software vendors tout the power of their business analytics tools to boost the laboratory’s bottom line, a newer application of information technology—clinical analytics—is elevating the role of the laboratory in personalized medicine.

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Put It on the Board, 10/17

October 2017—Houston labs learn: know the back roads: The disaster plan of the laboratories at Memorial Hermann Health System in Houston held up well in Hurricane Harvey, thanks to lessons learned in years past, but the labs have something new to add: Know in advance the back-road access routes to the various hospitals.

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Letters, 10/17

CAP TODAY provides valuable information that is important to guide the practice for many pathologists. However, an article published in the August 2017 issue, “Laboratory director duties clarified in 2017 checklist” by Anne Ford, has raised serious concerns among many pathologists, particularly members of the Chinese American Pathologists Association (CAPA).

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New tests, new wrinkles in HIV algorithm

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

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Turning points in transgender medicine

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

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Market based? A view of PAMA process, pricing

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

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From the President’s Desk: Entrustable professional activities, 9/17

September 2017—Academic Pathology recently published the results of a two-year project by the CAP Graduate Medical Education Committee to build a framework for teaching specific entrustable professional activities (EPAs) in pathology. Their scheme structures a competency-based approach to training mapped to the ACGME Milestones for pathology resident evaluation. Competency-based curricula are well suited to impart the breadth and depth of necessary fundamental knowledge to future pathologists.

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New requirement, updates in transfusion checklist

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

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Clinical Pathology Abstracts, 9/17

September 2017—Hemoccult testing before therapeutic anticoagulation in venous thromboembolism: Gastrointestinal bleeding is a major adverse event associated with therapeutic anticoagulation. Surveys of physicians have shown that concern for this event is one of the most common reasons to withhold anticoagulation in patients who have atrial fibrillation, acute coronary syndromes, or venous thromboembolism (VTE).

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Anatomic Pathology Abstracts, 9/17

Editors: Michael Cibull, MD, professor emeritus, University of Kentucky College of Medicine, Lexington; Rouzan Karabakhtsian, MD, PhD, associate professor of pathology, Albert Einstein College of Medicine, Montefiore Medical Center, 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. Detection of HPV ...

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Molecular Pathology Abstracts, 9/17

September 2017—Ability of cell-free circulating tumor DNA to reflect genomic changes in cancer deposits: Analysis of cell-free circulating tumor DNA is an emerging precision medicine technology that may be used to assess molecular alterations in cancer-derived DNA present in the blood, as well as to monitor cancer genomic changes over time and assess genomic changes and resistance following cancer therapy.

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Letters, 9/17

September 2017—I write this after reading “Total joints in view: to tilt at or to toss” (July 2017). I just completed my 42nd year as a general pathologist in an acute care community hospital that had 100 beds in 1971 and now has close to 500. From about 1980 (before we went to “separate billing”) through 2014, I fought relentlessly to have and keep the policy that all tissue get a pathology exam. These exams are needed:

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Q&A column, 9/17

September 2017— I received a sample with very high hemoglobin grossly. When I ran the sample on the Cell-Dyn Ruby, it was unable to calculate the parameters related to Hgb. I diluted the EDTA blood and ran the test again. In this scenario, should I multiply all the indices and Hgb-related parameters with the dilution factor? Which parameters should I multiply with the dilution factor?

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Newsbytes, 9/17

September 2017—Why so few women in pathology informatics? Alexis Carter, MD, did not realize she was a rare bird when, as a resident more than a decade ago, she acted on her penchant for health informatics. Dr. Carter had become interested in the field while working under a clinical chemist who developed computer programs that notified him when instruments weren’t performing as expected or when a lab result required further investigation.

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Put It on the Board, 9/17

September 2017—Eliminating CK-MB testing in suspected ACS: Health care leaders and clinicians should design and implement hospital-wide educational campaigns and partner with information technology and/or laboratory medicine staff at their institutions to remove CK-MB from standardized acute coronary syndrome routine order sets, say authors of a blueprint that could be a “first step to finally putting the CK-MB laboratory test to rest.”

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Making it personal: transgender medicine

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

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A slimmer molecular micro section among changes to checklists

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

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In digital age, new focus on specimen, slide prep

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

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From the President’s Desk: Staying close to our knitting, 8/17

August 2017—Nearly two years ago, I mentioned that I wanted to start a conversation about how we as pathologists and the CAP as our professional society must evolve in order to meet our emerging needs as individuals and as a specialty. Now, as my time in the perch is coming to a close, I’d like to explore what we have come to realize—and sometimes reinforced—about building and maintaining a complex infrastructure that reflects and serves our core purposes.

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Ownership remix as hospitals, national labs jockey for position

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

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

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

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Laboratory director duties clarified in 2017 checklist

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

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

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

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

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

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Molecular Pathology Abstracts, 8/17

August 2017—Mismatch repair-deficient tumors and immune checkpoint inhibitors: Immune checkpoint inhibitors have yielded highly effective therapeutic responses in a subset of tumors by eliciting an endogenous adaptive immune response. The determinants that define this subset of tumors are still unclear, but several markers, including PD-L1 expression and mutational burden, have been evaluated in various tumor types.

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Anatomic Pathology Abstracts, 8/17

August 2017—Analysis of microglandular adenosis and acinic cell carcinoma of the breast: Acinic cell carcinoma is an indolent form of invasive breast cancer, whereas microglandular adenosis has been shown to be a neoplastic proliferation. Both entities display a triple-negative phenotype and may give rise to, as well as display, somatic genomic alterations typical of high-grade triple-negative breast cancers. The authors compared previously published data on eight carcinoma-associated microglandular adenoses and eight acinic cell carcinomas subjected to massively parallel sequencing targeting all exons of 236 genes recurrently mutated in breast cancer or DNA repair related, or both.

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Clinical Pathology Abstracts, 8/17

August 2017—Etiology and clinical presentation of birth defects: a population-based study: Birth defects are inborn errors of development and include any structural or functional anomaly that impacts physical, intellectual, or social well-being. They are a considerable and growing clinical and public health challenge. Major birth defects are common and costly. Collectively, they are estimated to occur in one in 33 births, which translates into approximately 7.9 million babies affected worldwide. In the United States alone, the cost of care during a single year (2004) was estimated to be $2.6 billion.

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Q&A column, 8/17

August 2017—Due to an ever-changing workforce, many new and inexperienced technologists are working in the microbiology lab and appear to be having difficulty interpreting cultures and troubleshooting when an organism in question may not be significant. As an example, a scant growth of Micrococcus was isolated and reported from a cerebrospinal fluid culture; it was not seen in the Gram stain and was negative for leukocytes. Contaminants had been noted on some of the media plates at this time as well, but many of these inexperienced technologists do not have the confidence to ignore obvious contaminants or suggest the possibility of contamination. Is there some guidance or troubleshooting tools for these situations?

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Newsbytes, 8/17

August 2017—Health record security at root of personal grid architecture: Imagine the risks credit reporting agencies would face if they did not maintain databases of consumer transactions but instead requested information from various creditors and assembled credit reports from that information in real time. Yet that’s how health information exchanges typically work. And that, says William Yasnoff, MD, PhD, a consultant, physician, and computer scientist, is not a safe or effective approach.

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Put It on the Board, 8/17

August 2017—AML drug approved with companion diagnostic: The Food and Drug Administration approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation. The drug is approved for use with the RealTime IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

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Volume, value, technology steering 2017 instrument buys

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

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Hepatic neoplasms—cases, challenges, cautions

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

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Hepatocellular adenoma subtypes—Which is it?

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

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Integrative consults remove referral inefficiencies

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

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New pathology patient consult program takes off

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

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Multiplexed inherited cancer reference material, 7/17

July 2017—SeraCare Life Sciences launched the industry’s first multiplexed inherited cancer reference material for inherited disease testing by next-generation sequencing, according to the company. The Seraseq Inherited Cancer DNA Mix reference materials were developed to validate the ability of synthetic reference materials to address technically challenging variants.

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15th phlebotomy edition holds ‘latest, greatest’

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

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Clinical Pathology Abstracts, 7/17

July 2017—Effects of early tranexamic acid administration on women with postpartum hemorrhage: The leading cause of maternal death is postpartum hemorrhage, which is defined as blood loss of more than 500 mL within 24 hours of giving birth. The majority of such deaths occur in low-income and middle-income countries.

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Anatomic Pathology Abstracts, 7/17

July 2017—Potential quality indicators for lymph node staging of colon cancer: Evaluation of 12 or more lymph nodes is used as a quality indicator for adequacy of pathologic examination of colon cancer resections. The authors conducted a study to evaluate the utility of a focused lymph node search in the immediate vicinity of the tumor and a “second-look” protocol for improving lymph node staging in colon cancer.

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Molecular Pathology Abstracts, 7/17

July 2017—Immune checkpoint inhibition therapy, such as blockage of PD-1/PD-L1 interaction, has proven effective in many types of cancers. The mechanism underlying this therapy is postulated to involve “disinhibition” of tumor-infiltrating lymphocytes that respond to neoantigens expressed by tumor cells. In theory, the larger the number of neoantigens expressed, the greater the immune response resulting from disinhibition.

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Newsbytes, 7/17

July 2017—Machine learning: What will it do for pathology? If finance, online retail, and other industries are “embracing” machine learning, then the medical field is still in the polite handshake phase, despite the potential of this form of artificial intelligence to revolutionize health care. Recent research endeavors highlight just a few examples of what machine learning, which allows computers to analyze data, detect patterns, and build algorithms to guide decision-making, can contribute to the field of pathology alone.

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Q&A column, 7/17

July 2017—A laboratory is considering the implementation of a laboratory test for the diagnosis of Zika virus infection. This test is currently labeled as a test under the issuance of an Emergency Use Authorization. What specific regulations regarding the use of this test, quality control, and proficiency testing apply when performing this test on patient specimens?

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Put It on the Board, 7/17

July 2017—Putting pathology at the center of precision medicine: Michael H. Roehrl, MD, PhD, pathologist and director of the Precision Pathology Biobanking Center at Memorial Sloan Kettering Cancer Center, would like to see more joint development of companion diagnostics—pathologists and industry working together. It would lead, in his view, to better companion diagnostics.

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Diagnostics anchor freestanding ED

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

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New scope for trial drives FDA verdict

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

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

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

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Kevin B. Dole, MD | 1948–2017

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

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Book surveys patient safety from AP, CP standpoint

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

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Pathologist Cognition

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

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Helping phlebotomists ease pediatric patient anxiety

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

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

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

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Emergency hemorrhage panel gives surgeons what they need

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

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Anatomic Pathology Abstracts, 6/17

June 2017—Fallopian tube involvement in uterine serous carcinomas: The authors investigated the frequency and histopathologic and immunohistochemical characteristics of tubal involvement in uterine serous carcinoma to clarify the relationship between serous tubal intraepithelial carcinoma (STIC) and uterine serous carcinoma. They prospectively collected and reviewed, for the presence of tubal involvement, cases of the latter with complete tubal examination.

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Clinical Pathology Abstracts, 6/17

June 2017—Stem cell divisions, somatic mutations, cancer etiology, and cancer prevention: Cancers are caused by mutations that may be inherited or induced by environmental factors or that may result from DNA replication errors. The mutations due to random mistakes made during normal DNA replication may explain why cancers occur much more commonly in some tissues than others. Approximately three mutations occur every time a normal human stem cell divides.

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Molecular Pathology Abstracts, 6/17

June 2017—Whole genome single-cell copy number profiling on FFPE tissue samples Single-cell genomic methods take the concept of analyzing intratumor genetic heterogeneity to its logical conclusion. Traditionally, however, single-cell methods can only be used to analyze fresh or rapidly frozen tissue because formalin fixation and paraffin embedding degrades tumor DNA and cross-links proteins.

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Q&A column, 6/17

June 2017—Our analyzer reported nucleated red blood cells of six, with no cellular interference flag. The technologist missed that the automated NRBC was six. When he performed the manual differential, he noted more than five NRBCs and performed a corrected count and certified it. Is it acceptable to report out the automated white blood cell value as well as the corrected WBC?

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Newsbytes, 6/17

June 2017—Making the most of classroom technologies to train residents: Google the phrase “millennials killed” and you’ll discover a genre of Internet clickbait claiming the generation in question has rejected a lengthy assortment of previously popular items, from “the suit” to “napkins” to the “hangout sitcom.”

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Put It on the Board, 6/17

June 2016—CMS grants Qualified Clinical Data Registry status to Pathologists Quality Registry: The Centers for Medicare and Medicaid Services has approved the CAP’s Pathologists Quality Registry as a Qualified Clinical Data Registry, or QCDR. This makes it a reporting option for pathologists in fulfilling reporting requirements under Medicare’s Quality Payment Program.

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Acute leukemia workups, from top to bottom

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

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TLA in, volume up—micro labs take stock

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

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

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

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Study ‘opens the door’ to troponin, diabetes link

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

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From the President’s Desk: Soup’s ready, ketchup plopped, 5/17

May 2017—When we were growing up, my sisters would often ask, “Is it soup yet?” mimicking a popular TV commercial. The catch phrase caught on with the kids as a way to express eagerness for anything, lunch related or not. Another commercial popular back then showed an inverted ketchup bottle slowly yielding its contents to the force of gravity while Carly Simon belted out “Anticipation.” Part of me always wanted to tell my friends that because ketchup was thixotropic, a good shake would help the ketchup flow faster. I never did, probably because that wasn’t how the cool kids talked and partly because it seemed necessary to wait for the ketchup to plop.

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

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

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In flu season management, POC molecular to the fore

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

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How billing systems profit from analytics and automation

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

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For C. difficile, lab assessment alone is not enough

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

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No perfect approach to detecting C. diff infection

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

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

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

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

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

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

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

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New autopsy book ‘a complete learning experience’

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

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Pregnancy-related death: Hepatic System

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

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Anatomic Pathology Abstracts, 5/17

May 2017—Value of Ki-67 proliferative index in WHO-classified pulmonary carcinoids; Chromosomal abnormalities and genetic changes in uterine smooth muscle tumors; Expression of divergent endodermal lineage markers in yolk sac tumors; Interobserver reproducibility of percent GP4 in prostatic adenocarcinoma on biopsies; MELF pattern invasion: a report of FIGO grade 1 endometrial endometrioid adenocarcinomas; Cost-effectiveness of identifying H. pylori  in gastric biopsies without ancillary stains

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Q&A column, 5/17

May 2017—Is there any medical reason why a physician would ask the lab to run a complete blood count on cord blood? Does CAP checklist requirement HEM.23050 treat automated and manual differentials equally? That is, does the recommendation to report absolute counts apply also to manual differentials or only to automated differentials? What is the next step in resolving platelet clumping when it occurs in a citrate tube also?

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Put It on the Board, 5/17

May 2017—First here, then there—FISH testing in Kenya; FDA OKs PD-L1 biomarker test for urothelial carcinoma; FDA clears Roche Cobas e 801 immunoassay module; DiaSorin granted EUA for fully automated Zika IgM test; Advia Centaur XPT has comprehensive ID menu; Roche CINtec Histology test receives FDA clearance

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New molecular road map for CRC

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

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With cloud computing, sorting out pros, cons

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

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Primary aldosteronism: diagnostic team lifts clinical practice

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

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From the President’s Desk: If you can’t find your niche, build it, 4/17

April 2017—Our ubiquitous access to (and increasing reliance on) search engines such as Google, Siri, Cortana, and others has resurfaced much of the intellectual landscape. The historical “Guardians of the Truth” no longer sit comfortably in ivory towers waxing poetic while issuing definitive determinations of “fact.” Today, when we want to know something, we reach for our phones. The answers, devoid of context and authoritative citations, seem to be so simple there.

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Hemophilia management: Tips on monitoring modified replacement therapies

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

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Assessing LPL software

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

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Clinical Pathology Abstracts, 4/17

April 2017—Cost-benefit analysis of Chlamydia trachomatis screening in pregnant women: Chlamydia trachomatis is the most common bacterial sexually transmitted infection in the United States. In 2010, more than 1.3 million such infections in the United States were reported to the Centers for Disease Control and Prevention. In 2013, the estimated direct lifetime cost of treatment for chlamydia and its complications was more than $500 million.

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Anatomic Pathology Abstracts, 4/17

April 2017—Proposing prognostic thresholds for lymph node yield in oral cavity cancers: Prognostic lymph node yield thresholds have been identified and incorporated into treatment guidelines for multiple cancer sites, but not for oral cancer. The authors conducted a study to identify optimal thresholds in elective and therapeutic neck dissection for oral cavity cancers.

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Molecular Pathology Abstracts, 4/17

April 2017—Molecular profiling in MDS to predict clinical outcomes after transplantation: In recent years, several insights have been gleaned regarding the role of molecular markers for prognosis in myeloproliferative disease. This study expanded the use of molecular markers for prognosis in myelodysplastic syndrome (MDS) to predicting clinical outcomes after allogeneic hematopoietic stem-cell transplants.

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Q&A column, 4/17

April 2017—Our laboratory receives requests for breast predictive marker testing (estrogen receptor, progesterone receptor, HER2, Ki-67) on biopsies of bone metastases. Is it appropriate to perform this testing on decalcified tissue? Is there a regulatory speed limit—whether a per day or a per hour “at the microscope” workload limit—on surgical pathology slide interpretations, similar to workload limits for cytology screening?

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Newsbytes, 4/17

April 2017—New open-access website offers a treasure trove of digital slides; HL7 collaborates with Google; Health Catalyst and Regenstrief to advance text analytics technology; Corista teams with Elsevier to augment digital platform; Seacoast enhances system for document management

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Put It on the Board, 4/17

April 2017—At OSU, Inspirata completes deployment of WSI scanners, launches Consultation Portal: Inspirata has completed what it describes as the largest single-site deployment of whole slide image scanners at the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (The James) and the Department of Pathology, both located at Ohio State University Wexner Medical Center, Columbus.

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New rays on blood safety

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

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

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

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From the President’s Desk: We all need a safe place, 3/17

March 2017—Students of history tell us that a durable paradigm shift most often involves a long gestation, typically under the radar and recognized by a precious few. What they frequently fail to tell us is that the vast majority of prognosticators often turn out to be both flat-out wrong and invisible when the “future” arrives. Either way, however, the prevailing narrative points to uncertainty in the greater health care environment.

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HbA1c in CVD treatment: farewell to one size fits all

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

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Clinical Pathology Abstracts, 3/17

February 2017—Preventing genetic testing order errors via a lab utilization management program: Diagnostic errors, or failure to provide an accurate and timely diagnosis, impact an estimated 12 million outpatient care visits annually in the United States. These errors can often be attributed to the testing process, including test selection, ordering, retrieval, and interpretation. Literature about diagnostic errors has primarily focused on the outpatient setting; study of diagnostic error in the inpatient setting has been limited.

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Anatomic Pathology Abstracts, 3/17

March 2017—An immunohistochemical algorithm for ovarian carcinoma typing: Five major histotypes of ovarian carcinoma exist. Diagnostic typing criteria have evolved over time, and past cohorts may be misclassified by current standards. The authors undertook an endeavor to reclassify the recently assembled Canadian Ovarian Experimental Unified Resource and Alberta Ovarian Tumor Type cohorts using immunohistochemical (IHC) biomarkers and to develop an IHC algorithm for ovarian carcinoma histotyping.

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Molecular Pathology Abstracts, 3/17

March 2017—Effects of ovarian cancer cells manipulating mesothelial cells that line the peritoneal cavity: spread within the peritoneal cavity, resulting in cell implantation and metastasis at many secondary sites. The peritoneal cavity and associated organs are lined by a single layer of mesothelial cells that it has been suggested not only provides a physical barrier to prevent implantation and invasion but also plays a more complex interactive role in regulating cancer spread.

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Newsbytes, 3/17

March 2017—Pathologist to ‘name names’ in support of interoperability: Desperate times call for desperate measures. And while desperation may be a bit of an overstatement, a leader in pathology informatics says extreme frustration with LIS vendors, whose closed architecture, in effect, holds client data hostage, drove him to rally his colleagues to call out the offenders in a public forum.

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Q&A column, 3/17

March 2017—Our hospital system is implementing Sysmex instruments with a focus on the accuracy of the absolute white blood cell values—use of the absolute neutrophil count and immature granulocytes with the WBC as markers for septicemia. I then became aware that the hospital purchased the St. John Sepsis v14 protocol, which lists 10 percent bands as one of the markers for septicemia. The Rumke for 10 percent is 4–16. Using bands is not consistent with reducing manual differentials and is not an accurate parameter to use. Are there other protocols using WBC/ANC?

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Put It on the Board, 3/17

March 2017—LabCorp to acquire PAML: LabCorp, Providence Health & Services, and Catholic Health Initiatives announced Feb. 23 they have entered into a definitive agreement for LabCorp to acquire all of the ownership interest in Pathology Associates Medical Laboratories, LLC, which is owned by Providence and CHI.

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

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

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In cancer sequencing, a new lingua franca

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

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One bug or prix fixe? Respiratory pathogen testers weigh in

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

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From the President’s Desk: The deep roots of tall trees, 2/17

February 2017—One of my mentors, Richard E. Horowitz, MD, is thoughtful, perceptive, persuasive, and calmly persistent. He is a pathologist to the core, the physician inseparable from the scientist. When he wants to know something, he asks—and there’s plenty he wants to know. He is an emeritus professor of pathology with a long string of leadership credits, so he knows where to look for answers to deep questions. And his seemingly irrepressible inclination to mentor younger pathologists nurtures pragmatic leaders who can move our specialty forward.

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

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

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‘A marriage of virtual and real bronchoscopy’

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

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Molecular Pathology Selected Abstracts, 2/17

February 2017—Concordance between liquid biopsy and patient-matched tumor molecular testing: The use of sequence analyses of extended panels of genes to identify therapeutic targets in cancer is becoming commonplace. These assays typically rely on the availability of tissue biopsies as a source of genomic material, which can become a limitation in situations where insufficient tissue is available or an invasive procedure to collect tissue is impractical. A potential solution to this dilemma is the use of a blood-based, or liquid biopsy, approach, in which a peripheral blood sample is used as a source of tumor-derived genomic material, either in the form of cell-free DNA (cfDNA) or via circulating tumor cells (ctcDNA).

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Anatomic Pathology Abstracts, 2/17

February 2017—Findings in hysterectomy specimens of women with Lynch syndrome; Percentages and architectural types of Gleason pattern 4 cancer in radical prostatectomy; PTEN loss and chromosome 8 alterations in Gleason grade 3 prostate cancer cores; Lymph node count from neck dissection predicts mortality in head and neck cancer; Assessing the adequacy of lymph node yield for papillary thyroid cancer; Addressing perceived versus actual agreement in breast pathology interpretation; Cost-effectiveness of Oncotype DX DCIS score for guiding treatment of DCIS

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Q&A column, 2/17

February 2017—I have an oncology patient with a diagnosis of immune thrombocytopenia. The patient’s sample has been drawn in sodium citrate, EDTA K2, sodium heparin, and warm saline replacements, and a true platelet count cannot be obtained. Platelets clump in all tubes, and multiple platelet clumps are observed under the microscope. The patient doesn’t have thrombocytopenia. What else can I do?

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Newsbytes, 2/17

February 2017—In virtual informatics conference series, students teach and learn: In the television drama “The Paper Chase,” law professor Charles W. Kingsfield strikes fear and terror in the hearts of his students by “cold-calling” on them in class. Douglas Bell, MD, PhD, professor of medicine at the University of California, Los Angeles, and the program director of UCLA’s clinical informatics fellowship program, doesn’t want his own classes to be as stressful. But part of the pedagogical challenge for Dr. Bell and Bruce Levy, MD, who together run a virtual conference series for clinical informatics fellows, is finding a way to use active learning techniques, like calling on students, when the students are remote.

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With metagenomic sequencing, no pathogen can hide

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

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

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

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The what and why of diagnostic management teams

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

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Anatomic Pathology Abstracts, 1/17

January 2017—Drawbacks of reflex ER and PR analysis of DCIS in breast needle core biopsies; Analysis of eosinophils and mast cells of gastrointestinal tract in healthy children; Classifying gastric cancer into molecular subgroups; Clinicopathologic significance of mismatch repair defects in endometrial cancer; Use of immunostains to distinguish hepatic adenoma from hepatocellular carcinoma; Prognostic effect of PD-L1 expression patterns in cervical cancers; Variation in pattern-based classification of invasive endocervical adenocarcinoma

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Clinical Pathology Abstracts, 1/17

January 2017—Impact of laboratory cost display on resident attitudes and knowledge of costs: The Institute of Medicine report on health care quality recommends providing better care at lower costs. However, the United States has consistently seen rising health care costs instead of cost reductions. An approach to reducing unnecessary health care spending is to make physicians more aware of the cost of diagnostic tests.

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Q&A column, 1/17

January 2017—I have a technologist who is a recent graduate from a medical technology school. She has her BA but the school she attended did not offer an internship program. We are offering her one year of on-the-job training so she will be able to sit for her ASCP certification exam after completing the one year of training.

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Put It on the Board, 1/17

January 2017—Experts collaborate on evidence-based somatic variant classification system; FDA clears next-generation test for MRSA colonization; PMA approval granted for Aptima HIV-1 Quant; Henry Ford announces automation partnership; ArcherDX launches immune repertoire sequencing assays

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