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2014 Issues

Letters, 11/14

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

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 | 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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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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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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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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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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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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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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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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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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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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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 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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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Getting to the point in fragile X syndrome

January 2014—Can one equal 600? Is it possible for a mutation in a single nucleotide base in the FMR1 gene to be as potent as a run of more than 200 triplet repeats in causing fragile X-like symptoms? That was the question Stephen T. Warren, PhD, FACMG, raised in his keynote lecture at the 2013 meeting of the Association for Molecular Pathology. Two decades ago Dr. Warren and others showed that expansion of CGG triplet runs in the FMR1 gene is responsible for fragile X syndrome, or FXS. At the AMP meeting, Dr. Warren, who received the AMP Award for Excellence in Molecular Diagnostics, presented evidence that a point mutation in an FMR1 gene with a normal CGG repeat number can also cause intellectual disability and developmental delay, just as triplet repeats do, accompanied by other, non-FXS manifestations. In at least one case, a point mutation caused the full fragile X syndrome.

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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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From the President’s Desk: In policy matters, no pause in the cause, 1/14

January 2014—The landscape for physician payment is changing and all of medicine is feeling a persistent downward pressure on reimbursement, so this month’s column is a reality check and a call to arms. The reality check piece is that we’re not just talking about the shift from volume to value, the growing influence of coordinated care, or a new approach to Medicare physician payment updates.

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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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Q & A Column , 1/14

January 2014—I read a question and answer in the April 2001 CAP TODAY about platelet clumping on EDTA and whether vortexing is an acceptable procedure. A common solution suggested was to redraw the specimen into sodium citrate or acid citrate dextrose (ACD). How do you calculate the correction factor for blood drawn in an ACD tube? Our lab has an old procedure for ACD correction, and it is to divide the RBC of the EDTA tube by the RBC count of the ACD tube. I don’t have any reference for this and would appreciate information.

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Newsbytes, 1/14

January 2014—Why one pathologist champions social media—In an era when one angry tweet or provocative selfie can crash a career, the potential pitfalls of social media might be more obvious than their professional benefits. But one Arkansas dermatopathologist, an enthusiastic user of Facebook, Twitter, and YouTube, urges pathologists to consider the many opportunities social media offer, particularly for networking and education.

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