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2013 Issues

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Every month CAP TODAY brings essential news to all key decision-makers responsible for clinical laboratory purchases. This news includes advances in tests and equipment, trends in management and clinical operation, regulatory changes, and finance, plus news about the laboratory improvement programs of the College of American Pathologists.

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Anatomic Pathology Selected Abstracts, 1/13

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

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Clinical Pathology Selected Abstracts, 1/13

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

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Hematology lineup gets year-end look

December 2013—They say change is never easy, but Sysmex seems to be making a downright habit of it: “We have replaced almost 80 percent of our portfolio within the past year,” says Alan Burton, the company’s director of IVD product marketing. Coincidentally or not, Sysmex has seen much success in the last 12 months with its introduction of the XN-Series of automated hematology analyzers. “Already there have been well over 500 XN modules installed across North America,” Burton reports.

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Algorithm for HIV testing detects more cases, more quickly

December 2013—Screening to detect HIV infection is poised to make a leap into the 21st century. In his presentations on the proposed new screening algorithm, Bernard M. Branson, MD, points out that in 1989, when the now outmoded algorithm was recommended, the telephone booth was a common sight and the “portable” computer was the size of a small suitcase. Dr. Branson, associate director for laboratory diagnostics in the Division of HIV/AIDS Prevention at the Centers for Disease Control and Prevention, also points out that 1989 was the year of the dismantling of the Berlin Wall and the Tiananmen Square massacre.

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HPV a game changer in head, neck tumors

December 2013—Not that any cancer is ever “easy,” but until relatively recently, the culprit in head and neck squamous cell carcinomas was clear. The vast majority were caused by “smoking, smoking, and smoking,” says William Westra, MD, professor of pathology, oncology, and otolaryngology/head and neck surgery, and associate director, surgical pathology, The Johns Hopkins Medical Institutions. Call this HNSCC’s antediluvian era.

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FDA, CDC, and tests steer flu Dx into new season

December 2013—What Soren Kierkegaard said about life applies just as well to flu seasons: They are understood backwards, but they have to be lived forwards. They’re not easy to forecast. And perhaps that’s one reason why the Centers for Disease Control and Prevention has just announced a “Predict the Influenza Season Challenge,” offering $75,000 to the competitor who most successfully predicts the timing, peak, and intensity of the 2013–14 flu season using social media data.

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From the President’s Desk: All systems go, and those who make it so, 12/13

December 2013—Some nonpathologists attribute our ability to negotiate the cutting edge of science and medicine to the tools we use. I’m not saying that tools aren’t important, but we know better. Our ability to navigate today’s volatile waters is the product of an affinity for quality and an inclination for systems-based thinking. First we get it right. Then we get it out.

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Clinical Pathology Selected Abstracts, 12/13

December 2013—Impact of blood product ratios in massively transfused pediatric trauma patients

Few studies have included pediatric patients when analyzing the impact of plasma/packed red blood cell (PRBC) ratios during massive transfusions. The implications of changing to a 1:1 plasma/PRBC ratio are significant and relate to additional product exposure, transfusion reaction-related risk, and product wastage.

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Q&A Column, 12/13

December 2013—Our hematology standardization committee has asked us for input on performing cell counts on tubes No. 1 and No. 4 for cerebrospinal fluid. Each site in our system has a different protocol set up with its emergency department with regard to when a count is performed on tube No. 1 after counting tube No. 4. Some sites use RBC greater than five to automatically count tube No. 1 with or without an order to not delay patient care, whereas other sites use greater than 50 or greater than 200. Is there an established guideline recommendation for the number of RBCs seen on CSF tube No. 4 before doing an additional count on tube No. 1?

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Newsbytes, 12/13

December 2013—How software issues enhanced a vendor’s relationship with its client; Abbott releases new version of LIMS; Viewics introduces payer-focused solution; Syapse debuts clinical ‘omics’ reporting software; Telcor software receives certification as EHR module

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Anatomic Pathology Selected Abstracts, 12/13

December 2013— Human papillomavirus-related carcinomas of the sinonasal tract; Localized and metastatic myxoid/round cell liposarcoma; Urothelial carcinoma with prominent squamous differentiation in neurogenic bladder: role of HPV infection; Atypical leiomyomas of the uterus: a clinicopathologic study of 51 cases; Clinicopathological significance of HER2/neu genetic heterogeneity in various breast carcinomas; EIN with secretory differentiation: features and underlying mechanisms; Glypican 3 and arginase in diagnosing scirrhous hepatocellular carcinoma

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Put It on the Board, 12/13

December 2013—Illumina in November received premarket clearance from the FDA for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.

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Dropping the ball on critical value POC glucose results?

December 2013—Prompt reporting of critical laboratory results is considered an important patient safety goal. But for one of the most commonly performed tests, point-of-care glucose, there has been limited information about how critical results are handled. A new CAP Q-Probes study finds there is a great deal of variability. In addition to having widely differing critical result cutoff values, many laboratories are not repeating critical POC glucose test results for verification despite the relative high rate of erroneous results on first measurement.

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Put It on the Board, 11/13

November 2013—Myriad Genetics presented last month new clinical data from a study with myRisk Hereditary Cancer, a 25-gene hereditary cancer panel, that showed a 60 percent increase in mutations detected in cancer predisposition genes in patients with a prior history of colon cancer, polyps, or both. Myriad presented this study and data from four others at the Collaborative Group of the Americas on Inherited Colorectal Cancer Annual Meeting in Anaheim, Calif.

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Anatomic Pathology Selected Abstracts, 11/13

November 2013—Diagnostic and prognostic morphometric features in WHO 2003 invasive endometrial stromal tumors; Association of tumor staging with adverse clinical outcome in neuroendocrine tumors of appendix; Detection of HPV capsid proteins L1 and L2 in squamous intraepithelial lesions; Feasibility and safety of sequential research-related tumor core biopsies in clinical trials; Evaluation of breast amyloidosis finds AL type most prevalent; Outside case review of surgical pathology for referred patients: impact on patient care; Reporting trends for right-sided hyperplastic and sessile serrated polyps; Atypical leiomyomas of the uterus: a clinicopathologic study of 51 cases; Pathological diagnostic criterion of blood and lymphatic vessel invasion in colorectal cancer

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Newsbytes, 11/13

November 2013—New connectivity standards nearly ready to roll; CAP and mTuitive create application for care of cancer patients; European firm purchases Centricity LIS from GE; NovoPath offers Citrix platform for AP system; AHRQ tool focuses on lab test processes in medical offices; Brazilian hospital selects Cerner system

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New programs next year in gyn, nongyn cytopathology

November 2013—Participants in the CAP cytopathology programs will have new modules to select and new cases to learn from in 2014. Samples of static images that accompany the Touch Imprint/Crush Prep cases. In gynecologic cytopathology, a new L module for education will feature liquid-based SurePath and ThinPrep slide methods only. These will be designated PAPL/APAPL, with a choice of series one or two.

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Awards, honors given for sterling service

November 2013—Philip T. Cagle, MD, was presented Oct. 13 with the Pathologist of the Year award during an evening event at the CAP ’13 annual meeting in Kissimmee, Fla. At the same event, at the Gaylord Palms Orlando, Feriyl Bhaijee, MBChB, was honored as Resident of the Year, and Si Van Nguyen, MD, received the second annual CAP Foundation Gene & Jean Herbek Humanitarian award.

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Juggling IT demands—labs, vendors open up

Hopes, fears, frustrations, and change. In time for our annual LIS product guide (pages 23–38), that’s what CAP TODAY asked LIS companies and lab users of IT about. What we heard was talk of uncertainty, complexity, finite IT resources, the need to stay current, and, as one company president put it, “swimming with an anchor” attached. Here’s what they told us.

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Results reporting in microbiology: What’s needed, what’s not?

November 2013—After the patient specimens have been collected and the tests have been performed, after the legwork is complete and the results are in hand, reporting clinical microbiology findings should in theory be the easy part—the final step before an effective treatment plan is formed. But as any seasoned clinical microbiologist knows, that couldn’t be further from the truth.

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In predicting CKD risk, eGFR better when based on cystatin C

November 2013—Like turning around an ocean-going tanker, changing widely accepted testing practices in kidney disease, one of the nation’s most common disorders, may have to be done gradually. But the latest study comparing the biomarkers cystatin C and creatinine, published in the Sept. 5 New England Journal of Medicine (2013;369:932–943), is the most sweeping study to date and should provide new impetus to wider use of cystatin C.

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From the President’s Desk: PT for the passionate and the savvy, 11/13

November 2013—PT for the passionate and the savvy I believe that most pathologists and laboratory professionals enjoy refining systems and processes to further promote quality practices in their laboratories. We may not think about discipline and precision when somebody mentions passion, but passion is what those inclinations represent. While passionate pathology can manifest in a host of ways, this month I’d like to talk about how it drives excellence in CAP Surveys or proficiency testing (PT) programs.

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Keys to curbing tube interference with test results

November 2013—There’s nothing flashy about specimen tubes, which may look like the most mass-produced, commonplace items in the laboratory, but appearances can be deceptive. All tubes are not created equal. “We know that preanalytical errors account for the majority of errors in the laboratory, and many of those errors derive from the tube type in which you collect your sample,” says Leslie J. Donato, PhD, co-director of the hospital clinical laboratory and point of care at the Mayo Clinic in Rochester, Minn.

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No worries with new cancer biomarker templates

October 2013—For anyone worried about the new CAP reporting templates for cancer biomarkers, Patrick L. Fitzgibbons, MD, has an important message: Don’t panic. “These are nothing new,” says Dr. Fitzgibbons, a pathologist at St. Jude Medical Center, Fullerton, Calif., and chair of the CAP Cancer Biomarker Reporting Committee. “We’re not adding anything. The templates will look very familiar to users of the CAP cancer protocols. They shouldn’t be considered a significant burden.”

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Put It on the Board, 10/13

November 2013—LifeTech names TriCore an NGS Center of Excellence: TriCore Reference Laboratories and Life Technologies have signed an agreement to establish TriCore as a regional Next-Generation Sequencing Center of Excellence. The partnership is part of Life’s initiative to establish a global alliance composed of centers capable of running the most advanced NGS-based oncology panels for clinical research.

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Ways to move quickly on bloodstream infection

October 2013—Since 1942, when penicillin was first used to treat infections caused by gram-positive bacteria, many improved and potent beta-lactam antimicrobials have been developed. Yet today, if a patient in an intensive care unit develops a bloodstream infection with Staphylococcus aureus, that person has a one in three chance of dying. High mortality rates apply to many other pathogens that cause bloodstream infections in ICU patients—from one in five for coagulase-negative staphylococci and Escherichia coli to almost 40 percent for Pseudomonas aeruginosa and Candida spp. Enterobacter spp and Enterococcus spp have intermediate mortality rates: one in four and one in three, respectively. Even among patients on a non-ICU ward, bloodstream infections are associated with mortality rates between 20 percent and 30 percent.

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On cuts and consequences, pathologists make their case

October 2013—James Richard, DO, directs CAP-Lab, an independent laboratory in Lansing, Mich., where he manages the business and does everything from signing off on pathology reports to paying the mortgage on the building. But among the many issues he tackles running his practice and in the midst of a shift in health care in the U.S., a single rule proposed by the Centers for Medicare and Medicaid Services is what’s keeping him awake at night.

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‘Extra’ genetic info—too much, too quickly?

October 2013—In the 1997 film “Gattaca,” the movie-going public was introduced to a world in which biology was quite literally destiny. A world in which the probabilities encoded in one’s genome dictated virtually every aspect of one’s existence and where those found genetically wanting were relegated to society’s margins. Fortunately, genomics has so far yielded nothing so nefarious nor is it ever likely to, thanks in part to the vigorous debate that accompanies advances in genetic and genomic technologies. An example of this is the debate underway, and making medical news, among physicians, ethicists, and laboratory directors over the American College of Medical Genetics and Genomics’ recommendations on the reporting of incidental findings.

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New guideline takes on tough HER2 cases

October 2013—In HER2 testing for breast cancer, the term “equivocal” verges on being a four-letter word. If the patient has a clearly positive test result, therapies targeting HER2 become a treatment option, and a highly successful one at that. If the result is clearly negative, HER2-targeting drugs are off the table; the patient isn’t expected to benefit from the drugs, which are expensive and can be cardio- toxic.

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Q & A, 10/13

October 2013—We are standardizing procedures across our system. In thrombocytopenic patients with low platelet counts, some sites perform manual platelet counts using the Unopette system; others perform slide estimates to confirm an automated count. The need for improved turnaround times and greater accuracy and precision is clear. Are there studies that have evaluated the true accuracy of a low platelet count via a manual dilution technique versus the many automated techniques, and is there a true value in performing the time-consuming manual platelet count?

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Newsbytes, 10/13

October 2013—Microchip at core of Silicon BioDevices’ prototype product to test for troponin; FDA releases guide on wireless medical devices; Ventana and EMC partner on digital pathology endeavor; HIMSS launches Web site focused on health IT value; Pathologist group joins Xifin’s digital pathology network

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Clinical Pathology Selected Abstracts, 10/13

October 2013—Performance of assays used in the U.S. to diagnose Lyme borreliosis acquired in Europe: The most common tick-borne infection reported in the United States is Lyme disease, which can be acquired in the United States or while traveling in Europe. Evaluation of Lyme disease acquired in Europe, by doctors in the United States, is challenging because assays used in the United States use lysates of the original Borrelia burgdorferi sensu stricto isolate (B31 strain).

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Anatomic Pathology Selected Abstracts, 10/13

October 2013—Acellular mucin in rectal cancer patients showing pathologic complete response to preoperative chemoradiotherapy; Association between p16 expression and human papillomavirus in urinary bladder squamous cell carcinoma; Immunohistochemical signature comprising PTEN, MYC, and Ki-67 and disease progression in prostate cancer; Preoperative BRAF(V600E) mutation screening: likelihood of altering initial surgery for indeterminate thyroid nodules; Claudin expression in high-grade invasive ductal carcinoma of the breast; Interobserver agreement in assessing lung cancer: H&E diagnostic reproducibility for non-small cell lung carcinoma

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Molecular testing platforms a land of plenty

October 2013—If you’ve ever seen what happens when someone accidentally puts regular liquid soap in a dishwasher, you’ll have a good mental image of just how vigorously the automated molecular testing market is bubbling over with new assays. HCV genotyping, rifampin resistance, group A Streptococcus—vendors are pouring these and many other tests into a market that, by all accounts, is more than eager for them.

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Letters, 10/13

October 2013—A CAP-accredited, multi-department laboratory, with 25 well-trained employees. A full-time staff of four American Board of Pathology-certified pathologists, including one with cytopathology boards. A rigorous quality assurance program involving clinicians and pathologists. An integrated electronic medical record system. Constant communication between administrative, technical, and clinical staff.

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An uneasy dance with POC glucose in the ICU

October 2013—Too much of a good thing can be wonderful,” Mae West famously said. And some feel our culture of excess reflects that value. Perhaps as a reaction there has been a surge of interest recently in the embrace of “enough” as a worthwhile goal. But when it comes to precise measurement of glucose values in the intensive care unit, the often-warring needs for speed and accuracy make the issue a critical matter of patient care. For point-of-care glucose testing in the ICU, how much precision is “enough”?

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Q & A, 9/13

September 2013—Our clinicians are asking about testing for IgG4-related disease. What role does IgG4 immunohistochemical staining play? IgG4-related disease is a recently recognized fibroinflammatory condition that may affect a wide variety of organ systems, producing mass lesions and generally responding to immunosuppressive therapy. The pancreas, salivary/lacrimal glands, and kidney are frequently affected, but almost any tissue may be involved, including aorta, pleura, retroperitoneum, and lymph nodes.

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Anatomic Pathology Selected Abstracts, 9/13

September 2013—Quantification of the Ki67 proliferative index in neuroendocrine tumors of the gastroenteropancreatic system; Clinicopathologic and immunohistochemical study of intrapulmonary SFTs; Papillary mucinous metaplasia of the endometrium as a precursor of endometrial mucinous adenocarcinoma; Expression of miRNAs and PTEN in endometrial specimens; Molecular investigation of lymph nodes in colon cancer patients using OSNA; Thymidylate synthase expression and molecular alterations in adenosquamous carcinoma of the lung; Microdensitometry of osteopontin as a prognostic biomarker in colorectal carcinoma tissue microarrays; Evaluation of pathological and molecular features in clinically aggressive dermatofibromas; Interobserver agreement in the reporting of colorectal polyp pathology by bowel cancer screening pathologists

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Cancelled lab tests—study analyzes why

September 2013—A handful, a fraction of a percent, a tiny portion. In most institutions, that’s about how many tests are cancelled after they’ve been ordered and a specimen has been sent to the laboratory. But even that small number can have significant quality implications. The authors of the Q-Probes study, ”Reasons for Test Cancellation,” looked at more than a million specimen accessions at several dozen institutions, to get a fix on why tests are being cancelled and to gain insight into how laboratories can bring that number down. As the study makes clear, there is definitely room for improvement.

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With molecular testing, better infection control

September 2013—Rapid and accurate molecular assays have gradually infiltrated the field of bacterial diagnosis. For several potentially lethal nosocomial pathogens—Clostridium difficile, vancomycin-resistant enterococcus, Mycobacterium tuberculosis, and methicillin-resistant Staphylococcus aureus—FDA-approved molecular assays are making a difference. Not only have they improved the accuracy of diagnosis, benefiting patients and clinicians, they have also been a boon to infection control practitioners.

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AMP case report: aCGH as a diagnostic aid in a childhood Spitzoid melanoma

September 2013—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 third such case. (See the February 2013 issue for the first, on multilocus sequencing for rapid identification of molds, and last month’s issue for the second, on the importance of screening for Lynch syndrome in patients with endometrial cancer.) 

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Letters, 9/13

We read with interest your article in the June issue, “To reduce UTIs, one lab takes a long, wide look.” We strongly agree that there is inappropriate prescribing of antibiotics for patients whose urine cultures are reported with organism identification and antibiotic susceptibilities but who do not have urinary tract infection. This is because many physicians send urine for culture inappropriately and then equate a positive result with infection; they believe that these laboratory tests are diagnostic for UTI.

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A pathologist’s observations about in-office AP labs

September 2013—With the GAO reporting that self-referral of anatomic pathology and other services costs Medicare millions, and with legislation introduced Aug. 1 that would prohibit such self-referrals, physician groups are fighting back, arguing that the exemptions allow for more integrated care. Not so, says pathologist Matthew Foster, MD, who shared what he’s observed about in-office AP labs in an Aug. 8 CAP online panel discussion. He is with Pathology Consultants of Central Virginia, an independent lab that provides services to Centra Health, a nonprofit hospital system serving a community of about 350,000. He is also associate medical director of the Alan B. Pearson Regional Cancer Center in Lynchburg. Dr. Foster’s edited remarks follow.

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From the President’s Desk: It’s our teammates who matter most

September 2013—Cross-country runners train for terrain and endurance. Downhill routes require biomechanical adaptations because the runners must anticipate and adjust for sudden rocks in the road or lack of traction. While there is time to plan around threats on an uphill route, threats to safety or stability in a downhill race may manifest too late for avoidance strategies. Agility matters.

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MOC:PQRS incentive: what it is, how to earn it

September 2013—The Centers for Medicare and Medicaid Services has approved the American Board of Pathology for participation in the MOC:PQRS Additional Incentive Program. This approval allows ABP diplomates who are participating successfully in the PQRS incentive program to earn an additional 0.5 percent incentive payment on the total Medicare part B allowed charges for participating in MOC:PQRS in 2013.

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Put It on the Board, 9/13

September 2013—FDA clears Vitek MS: BioMérieux has been granted FDA 510(k) de novo clearance for Vitek MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. To gain FDA clearance, BioMérieux submitted data from a multi-center study consisting of 7,068 clinical isolates.

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Risk, compliance, pay—a juggling act for labs

August 2013—Theatergoers don’t want to see theunderstudy. Passengers don’t want to encounter a series of “flight delayed” messages on the departures board. And while it may not be every laboratory’s worst nightmare, no pathologist wants to open a letter from a government agency or payer that starts out, “It has come to our attention,” followed with words like “violation” and “false claim.”

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Toolkit lets labs make the case for the right LIS

August 2013—In ancient Rome, the legions might gird for combat with a muscled cuirass, helmet, and greaves, and carry a pilum. But none of them ever had to confront a hospital system C-suite, with high-level executives whose titles start with “chief” deciding between a single, enterprisewide information system or a “best-of-breed” laboratory information system.

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AMP case report: A 48-year-old woman with endometrial cancer. Importance of screening for Lynch syndrome in patients with EC

August 2013—Lynch syndrome (LS) is an autosomal dominant syndrome that predisposes patients to multiple malignancies. LS has traditionally been thought of as a colorectal-cancer-dominated syndrome; however, the incidence of endometrial cancer in women with LS actually exceeds that of colorectal cancer. Here we report a case of a woman with metachronous colorectal cancer and endometrial cancer, with the goal of increasing awareness of the need to screen endometrial cancer patients for LS. Identifying these patients is important not only for the patient but also for other family members who would benefit from genetic counseling and surveillance for LS-associated malignancies.

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From the President’s Desk: Workforce advocacy: everyone’s job

August 2013—Many people don’t know what we pathologists do. This is concerning, especially when some of the same people are responsible for determining levels and allocation of funding for graduate medical education, keeping our training programs open, or encouraging careers in pathology. I hope this column ignites a sense of urgency around funding for pathology training and recruiting a strong workforce, for without both our patients will suffer an indefensible loss.

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Checklists 2013: newborn screening and MALDI-TOF

August 2013—At CAP ’11, then president-elect Stanley Robboy, MD, sat at a table in a conference room. He didn’t know those seated with him but he and they started to chat. The conversation turned to Dr. Robboy’s goals for his upcoming presidential term, and a member from Saudi Arabia, Amal Saadallah, MD, PhD, proposed that newborn screening requirements be created for accreditation.

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Cytopathology and More | Cytologic-histologic correlation: And the answer is…

August 2013—You have a great gynecologic cytology case, a patient with atypical endometrial cells on Pap test that you believe might represent a low-grade endometrial adenocarcinoma, but it has been four weeks and you have had no feedback about the patient’s outcome. It seems as if there have been a lot of atypical endometrial cells on Pap tests lately. Could it be due to the implementation of a new liquid-based technology for Pap tests in your laboratory? Fortunately, your laboratory performs cytologic-histologic correlation monthly, so you ask the medical director if she has noticed any trends in the rate of atypical glandular cells, and what the corresponding biopsies have shown. To your relief, the patient had a biopsy showing low-grade endometrial carcinoma, and the laboratory statistics have shown only a slight increase in atypical glandular cells since the new technology was implemented. The medical director informs you that she has been recording these data as a special QA project to determine if the increase is due to over-interpretation of reactive glandular cells, because the technology enhances nuclear and cytologic details of glandular cells.

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Cytopathology and More | Managing abnormal screening results: highlights of new guidelines

August 2013—The field of cervical cancer screening saw many developments in 2012. In April last year, the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology published new guidelines for cervical cancer screening, most notably raising the age at which screening should begin, extending the interval between screening tests, and giving preference to simultaneous Pap and human papillomavirus co-testing in women ages 30 to 65.1 Almost simultaneously, the U.S. Preventive Services Task Force published similar screening guidelines.2 Then, in July, the CAP and ASCCP published the results of a joint project recommending a uniform Lower Anogenital Squamous Terminology (LAST).3 Finally, in September the ASCCP led a consensus conference of 23 participating organizations to update guidelines for managing abnormal cervical cancer screening test results. In April of this year, these updated guidelines were published simultaneously in the Journal of Lower Genital Tract Disease and Obstetrics and Gynecology.4,5

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Microbiology QA, measure for measure

August 2013—In the May 20, 2013 issue of the New Yorker, Google co-founder Sergey Brin is quoted as saying of Internet security: “In big corporations people don’t understand what security people do, for the most part, and no one pays attention to them unless something goes wrong. Frankly, a lot of companies aren’t that interested in security.”

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Anatomic Pathology Selected Abstracts, 8/13

August 2013—Endometrium as a primary site of origin of pelvic high-grade serous carcinoma in BRCA1 or BRCA2 mutation carriers; Criteria and pitfalls in diagnosis of lymphovascular invasion in prostatectomy specimens; An interobserver study of reproducibility in subtyping pulmonary adenocarcinomas; Value of PAX8, PAX2, claudin-4, and h-caldesmon in identifying peritoneal epithelioid mesotheliomas; Clinicopathologic study of cutaneous digital papillary adenocarcinoma;

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Newsbytes, 8/13

August 2013—From pathologist to IT professional: a telling of five tales: Many people wear more than one hat in life, but rarely are they employed as both a hospital’s pathologist and information technology professional—consecutively or simultaneously. Only a select group has donned both chapeaux.

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Q & A, 08/13

August 2013—What are considered best practices for tracking re-sult trending in the lab? We use hemoglobin running mean in our hematology department because it is built into the analyzer software. The chemistry department will have a difficult time applying moving averages without purchasing middleware.

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Expressions follow SCOTUS gene ruling

July 2013—The U.S. Supreme Court last month handed down a landmark decision on a narrow issue with broad implications for molecular medicine: Can genes be patented? In ruling that as products of nature, genes did not meet the criteria for patent eligibility, the Court brought its collective wisdom to bear on an issue that has troubled physicians, ethicists, and patients for nearly 20 years and hindered innovators in academia and industry. The Court declared invalid the patents on the genes BRCA1 and BRCA2, patents that were at the heart of an intellectual property estate that enabled Myriad Genetics to create a commercial monopoly in BRCA testing.

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Test utilization: a united front against waste

July 2013—When it comes to laboratory test orders, the connection between bloodletting and financially draining an institution is more than metaphorical. But a wide range of techniques can help stem test overutilization, clinical laboratory experts have found; you don’t have to drive a stake through a vampire’s heart to stanch the flow.

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Q & A, 7/13

July 2013—Can you clarify the difference between the terms “optimization,” “validation,” and “verification” as used in immunohistochemistry? These three terms relate to the processes that the laboratory must undertake before new diagnostic, prognostic, or predictive immunohistochemistry markers are used for clinical and/or pathologic decisionmaking.

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Put it On the Board, 7/13

July 2013—The FDA approved Abbott’s hepatitis C virus genotyping test for use in the United States. The RealTime HCV Genotype II test differentiates genotypes 1, 1a, 1b, 2, 3, 4, and 5 and is run on the automated m2000 platform. Gavin Cloherty, PhD, Abbott Molecular’s director of scientific affairs, told CAP TODAY the test has a 99.5 percent accuracy relative to sequencing and a greater than 99 percent discrimination of HCV genotype 1 subtype 1a versus 1b. Time to result for 22 samples and two controls, he said, is 5.25 hours, with 30 minutes hands-on time.

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AMP v. Myriad Genetics: the end of the beginning

July 2013—The most remarkable fact about the June 13 decision of the Supreme Court in Association for Molecular Pathology v. Myriad Genetics, ___ U.S. ___ (2013), is that both sides are proclaiming victory. The physicians and geneticists who challenged efforts to enforce patents on the BRCA1 and BRCA2 genes are elated that the Court has squarely held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”

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Anatomic Pathology Selected Abstracts, 7/13

July 2013—Intraoperative pathologic examination in the era of molecular testing for differentiated thyroid cancer: Diagnostic thyroidectomy is typically indicated for indeterminate thyroid cytology results. Traditionally, intraoperative pathologic examination (IOPE) helped guide the extent of initial surgery. Preoperative molecular testing of fine-needle aspiration cytology has emerged as another diagnostic adjunct, is highly specific for thyroid cancer, and can lead to appropriate initial total thyroidectomy.

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Clinical Pathology Selected Abstracts, 7/13

July 2013—Risk factors for first venous thromboembolism around pregnancy: Venous thromboembolism is a serious maternal complication occurring at a rate of one to two per 1,000 maternities during pregnancy and the puerperium. Venous thromboembolism (VTE) is a leading cause of maternal mortality in developed countries and an important source of morbidity in the form of post-thrombotic syndrome.

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With TSH testing, no lack of discord

June 2013—In 219 BCE, after he had unified the seven warring states to establish the nucleus of the Chinese empire, the First Emperor of China promulgated uniform administrative practices throughout the land. One section of his decree read: All men under the sky toil with a single purpose. Tools and measures are made uniform. The written script is standardized. Wherever the sun and moon shine.

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From the President’s Desk: Now and Future Policy Agenda

June 2013—My father and his brother were teenagers when they found steerage on a ship to the United States in 1910. They arrived with neither English nor assets but with a firm belief that this democracy would provide opportunity. My father completed high school, college, and medical school under difficult circumstances; the long effort gave shape to his hopes. He became a physician who loved his work. We absorbed by osmosis the satisfactions of a life devoted to thoroughly unreasonable goals. I still believe what we learned then: In this country, effort that is intentional and persistent will be respected and rewarded.

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Keeping an eye on H7N9, and learning from the past

June 2013—What began as a trickle of reports in China earlier this year swelled into a flood of patients with grave flu-like symptoms. Each time, PCR assays returned the same result: unsubtypable influenza A. Amid a rising mortality rate, viral samples were sent to China’s national laboratories for sequencing analyses. On March 31, Chinese officials posted the results to an open-access database and alerted the World Health Organization to a public health emergency of international concern: The H7N9 epidemic had begun.

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How labs are taming test utilization

June 2013—It might be a legacy of the economic downturn. Perhaps it is the prospect of increased capitation under health care reform. Or it could be the stunning price tags of some new tests on the clinical laboratory test menu. Whatever the cause, health systems across the country are increasingly moving beyond education and retrospective review to more specific, targeted, prospective controls on test utilization.

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Newsbytes, 6/13

June 2013—Clinical IT help desks bring service to new level; PathCentral introduces plug-and-play AP system; ONC guideline addresses transition of care under meaningful use criteria; Laboratory systems certified as electronic health record modules

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Q & A, 6/13

June 2013—Say an individual is stuck with an HIV-contaminated needle or occult infected with HIV by bodily fluid transmission and is started on preventive antiretroviral treatment to prevent permanent infection. (Treatment protocol is one-month intensive treatment.) Is there any known laboratory procedure by which a specimen could be isolated to determine by culture if the patient was indeed infected (assuming the patient is seronegative six months plus after treatment was initiated)?

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Anatomic Pathology Selected Abstracts, 6/13

June 2013—Prolonged cold ischemia time and ER immunohistochemistry in breast cancer: To aid detection of estrogen receptor expression in breast tumors, the American Society of Clinical Oncology and College of American Pathologists recommend that cold ischemia time be kept under one hour. However, data to address the upper threshold of cold ischemia time are limited.

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Clinical Pathology Selected Abstracts, 6/13

June 2013—Ehrlichiosis is a tick-borne disease that may be asymptomatic or result in fatal sepsis. Ehrlichiosis transmitted from transfusion of blood products has not been documented. A case report of a 9-year-old Georgia boy with a history of acute lymphoblastic leukemia is the first report of Ehrlichia ewingii infection transmitted by a platelet transfusion. The authors first describe the patient as presenting to the hospital with complaints of fever, fatigue, malaise, vomiting, diarrhea, and petechial rash.

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From the President’s Desk: Next-generation communication

May 2013—Eric Topol, MD, director of the Scripps Translational Science Institute, chief academic officer for Scripps Health, and editor-in-chief of Medscape, will present at the CAP ’13 Spotlight Reception in October. We (CAP CEO Charles Roussel; Nazneen Aziz, PhD, director of molecular medicine and staff lead for the CAP Next Generation Sequencing Working Group; and I) invited Dr. Topol to speak after we met with him to talk about our interest in genomic medicine and the steps we have taken—through the Transformation Program Office, CAP Learning, and the Laboratory Accreditation Program—to spearhead efforts to fully integrate cutting-edge genomics into pathology practice.

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Cytopathology and more: Interrater agreement of anal cytology

May 2013—Anal-rectal cytology has been used to evaluate HPV-related lesions of the anal canal, particularly in high-risk populations. Because anal cancer is uncommon in the general population, there is no utility in surveillance cytologic assessment on a population-wide scale (as with the Pap test for cervical disease). However, in certain populations, such as men who have sex with men (MSM) and HIV-positive men and women, the risk for anal cancer is higher and approaches the risk of cervical cancer reported in unscreened populations of women. Thus, given that anal cancer shares an HPV-related etiology with cervical cancer and involves a similar squamous mucosal site, anal cytology has been recommended as a method of screening for the prevention of anal cancer through the detection of precancerous lesions (anal intraepithelial neoplasia, AIN). Although the Bethesda terminology, criteria, and guidelines for anal cytology specimens parallel those for cervical cytology, degenerative cellular changes, extensive keratinization, and contaminating fecal material frequently make it more difficult to evaluate these specimens than to evaluate cervical specimens. Because there are limited data on the interobserver agreement of anal cytology (as compared with cervical cytology), Teresa M. Darragh, MD, et al., investigate interrater agreement of anal cytology as well as the relationship between biomarkers and anal cytologic interpretations (Cancer Cytopathol. 2013;121[2]:72–78).

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Cytopathology and more: Know where the deficiencies and dust hide

May 2013—Accreditation inspections are inevitably stressful events. Having a colleague you’ve never met walk through your lab with a checklist looking for how you’ve slipped up reminds me a bit of my mother’s first visit to my apartment when I was a newlywed. I had cleaned everything, including every nook and cranny that weren’t part of my usual routine. I even bought a new shower curtain to ensure no possible hint of mildew. I thought the place looked terrific and that my high level of preparation would surely be sufficient to meet my mom’s white glove standards. Little did I expect that she would peer down the shade of my living room lamp shortly after arriving and remark that I really should dust my light bulbs. It is hard to ever be fully prepared for a June Cleaver mom or to read the mind of a CAP inspector. Fortunately, deficiencies in cytopathology are relatively infrequent and don’t involve eliminating dust on light bulbs. Nonetheless, being aware of the top three checklist items that are most often cited as phase one and two deficiencies can be helpful in your inspection preparation and will assist you in avoiding pitfalls.

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Standard of care hits close to home

May 2013—Town versus gown: It’s a long-standing source of tension in medicine. In November 1963, JAMA published a piece on the pathology of this so-called syndrome. The disease was characterized as both chronic and acute, with the author blaming social forces, the structure of medical practice, philosophical differences in medical education, and the rise of specialization, as well as a host of secondary etiologic factors. After much hand wringing, the author called for a renewal of spirit to end this classic divide.

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Put it On the Board, 5/13

May 2013—Omnyx digital pathology OK’d for routine use in Canada, Europe; PCR platform, kit cleared for H7N9; CollabRx forms Pan Cancer molecular oncology editorial board; ‘Time for omic ancillary systems’; Thermo Fisher to acquire Life Tech; First next-generation sequencing assay for GE Healthcare; FDA clears BD Diagnostics’ C. diff assay; Foundation Medicine, Sloan-Kettering to co-develop test for hematologic cancers

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Clinical Pathology Selected Abstracts, 5/13

May 2013—Although allogeneic bone marrow transplantation can cure sickle cell disease, human leukocyte antigen-matched donors are difficult to find, and the toxicities of myeloablative conditioning prior to transplants are a major risk factor for morbidity and mortality in most adults. The authors developed for patients with sickle cell disease newer bone marrow transplant regimens using nonmyeloablative conditioning regimens and human leukocyte antigen (HLA)-haploidentical donors.

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Anatomic Pathology Selected Abstracts, 5/13

May 2013—Pseudomyxoma peritonei originating from an appendiceal mucinous neoplasm remains a biologically heterogeneous disease. The authors conducted a study to evaluate outcome and long-term survival after cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) consolidated through an international registry study. A retrospective multi-institutional registry was established through the collaborative efforts of units affiliated with the Peritoneal Surface Oncology Group International.

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Q & A, 5/13

May 2013—We are relocating to a new laboratory on a different floor in our hospital. There is little guidance from regulatory agencies on revalidating analyzers after the move. Decisions are left to the discretion of our pathologist. What kind of precision/accuracy/ normal range/patient sample/control testing do you recommend?

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Newsbytes, 5/13

May 2013—How software sent to the ocean floor is aiding cancer cell detection; Lab interoperability white paper addresses interface issues; NovoPath launches batch sign-out module for AP software; Atlas Medical releases functionality designed to boost lab revenue; Thermo Fisher Scientific introduces tool for cloud-based communication; PathCentral forges alliances via new digital pathology network; Data Innovations marketing enhanced version of Instrument Manager

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With NGS, new hope for managing thyroid nodules

April 2013—Faced with assessing one of the hundreds of thousands of patients who present with thyroid nodules each year, clinicians know that the initial diagnostic steps are straightforward. With fairly good reliability, using ultrasound examination, fine-needle aspiration, and cytologic examination, they can determine in about 70 to 80 percent of cases whether the nodule is benign or malignant. And good treatment options exist for those in the latter category.

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Missing transcripts, diplomas snag labs

April 2013—The paperless office may be just around the corner, and virtual reality may lie ahead too. But for the time being, when it comes to demonstrating that personnel have the required educational qualification to perform nonwaived point-of-care testing, the Centers for Medicare and Medicaid Services and the CAP have a message for laboratory directors: Primary documents are king. For accreditation under CLIA, it’s not enough to know personnel are qualified because of their certificate or license; you have to prove it with copies of their transcripts and diplomas.

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HCV, CMV viral load—treatment, testing, timing

April 2013—Treatment for hepatitis C virus infection turned a corner in 2011 when direct-acting antiviral inhibitors were approved and combined with dual therapy—pegylated interferon and ribavirin. Cure rates shot up from about 45 percent to 70 to 75 percent. With antivirals that are even more potent in late-stage clinical trials now, “Use of oral antiviral therapy without interferon appears to be a real possibility for the near future,” said Mitchell L. Shiffman, MD, director of the Liver Institute of Virginia at Bon Secours Health System in Richmond and Newport News, in an Association for Molecular Pathology session at the 2012 annual meeting, where he spoke about viral load monitoring for HCV.

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New guidance on lung cancer testing

April 2013—It was a monumental task: create a molecular testing guideline for lung cancer. Among other tasks, those involved (representing the CAP, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology) reviewed 1,533 abstracts and read, in detail, 521 full-text articles. There was extensive evidence grading; naturally, new literature was published in the interim, which required even more reviews. The payoff was the first international, evidence-based, multidisciplinary guideline for this part of lung cancer care. It contains 37 items addressing 14 subjects, including 15 recommendations (evidence grade A/B).

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Put it On the Board, 4/13

April 2013—ACMG issues guidance on incidental findings: The American College of Medical Genetics and Genomics released last month its recommendations for reporting incidental findings in clinical exome and genome sequencing. An ACMG working group, working with 15 experts who served as external reviewers, specifies a set of disorders, the relevant associated genes, and certain categories of variants that should be reported, based on a consensus-driven assessment of clinical validity and utility.

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Newsbytes, 4/13

April 2013—Computing for Good project proving great for African labs; Cerner purchases Labotix Automation, PureWellness; Six health IT companies forge interoperability organization; Liaison Technologies acquires Ignis Systems; Psyche Systems offers new LIS and updates another; AP-Visions marketing LIS to small hospitals and POLs; HL7 releases intellectual property as free offering

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Letters, 4/13

April 2013—Remembering Lee VanBremen, PhD: I read with interest the reminiscences about former CAP executive vice president Lee VanBremen, PhD (February 2013, page 12). It was my good fortune to serve on the CAP Board of Governors while Dr. VanBremen was the EVP. It became immediately apparent that he was a gentleman, highly intelligent, quiet, and reserved.

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Q & A, 4/13

April 2013—In the point-of-care test for the determination of prothrombin time and International Normalized Ratio by fingerstick in a physician’s office, are controls (normal and elevated) available for adequate QC determination? Are physician office labs not governed by the same basic principles governing formal clinical laboratories? Are they permitted to run tests without running QC? Are there potential legal ramifications for having obtained an incorrect result for a POC test performed in a physician’s office without the proper use of QC, leading to a catastrophic patient result?

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Anatomic Pathology Selected Abstracts, 4/13

April 2013—Preoperative diagnosis of benign thyroid nodules with indeterminate cytology: Approximately 15 percent to 30 percent of thyroid nodules evaluated by fine-needle aspiration are not clearly benign or malignant. Patients with cytologically indeterminate nodules are often referred for diagnostic surgery, though most of these nodules prove to be benign.

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Clinical Pathology Selected Abstracts, 4/13

April 2013—Variant of TREM2 associated with risk of Alzheimer’s disease: Alzheimer’s disease is the most common form of dementia in the elderly. The disease is characterized by the formation of extracellular amyloid plaques, intracellular neurofibrillary tangles, and loss of neurons, which results in brain atrophy and progressive loss of cognitive function.

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Policing blood use pays off for Allina Laboratories

March 2013—A January study of almost 1,000 patients with acute gastrointestinal bleeding has found that restrictive blood transfusion strategies produce better patient outcomes. The study, “Transfusion strategies for acute upper gastrointestinal bleeding,” discovered that patients with severe acute upper GI bleeding who received blood transfusions when their hemoglobin levels fell below 7 g/dL, rather than 9 g/dL, had higher probabilities of survival at six weeks, as well as reduced rates of further bleeding and fewer adverse events (Villanueva C, et al. N Engl J Med. 2013;368:11–21).

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TB or not TB? Newer assays settle in

March 2013—Though tuberculosis is primarily diagnosed and treated in the public health system, there’s a need for greater knowledge about TB in the private sector, says Sundari Mase, MD, MPH, of the CDC’s Field Services and Evaluation Branch, Division of Tuberculosis Elimination. Among private physicians, she says, “there is little institutional knowledge about TB.” When Dr. Mase sees patients, often she’ll note diagnostic delays in recognizing TB, “delays that occur because physicians aren’t thinking about TB.”

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What happened when lab set sights on parasites

March 2013—When Bobbi S. Pritt, MD, director of clinical parasitology and virology in the Division of Clinical Microbiology at Mayo Clinic, set out to improve test utilization among the physicians for whom her laboratory performs assays, she figured that knowledge was power. Simply educate the clinicians, she thought, and surely they would begin to order the most appropriate tests for their patients.

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Put it On The Board, 3/13

March 2013—FDA clears ALK automated gene scanner; precision medicine center at Weill Cornell, NY-Presbyterian; sequence-based system cleared for HLA typing; Abbott to collaborate on companion CLL test; Cepheid, OHSU to develop oncology assays for Xpert; Clarient adopts Qiagen KRAS; test could reduce number of repeat biopsies; and Ventana, Biocare sign p63 license agreement.

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Q & A, 3/13

March 2013—Submit your pathology-related question for reply by appropriate medical consultants. CAP TODAY will make every effort to answer all relevant questions. However, those questions that are not of general interest may not receive a reply. For your question to be considered, you must include your name and address; this information will be omitted if your question is published in CAP TODAY.

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Anatomic Pathology Selected Abstracts, 3/13

March 2013—Immunohistochemical assay versus Oncotype DX qRT-PCR assay for estrogen and progesterone receptors; accuracy and precision of endometrial intraepithelial neoplasia diagnosis; histologic patterns and molecular characteristics of lung adenocarcinoma; MicroRNA expression profiling as a diagnostic tool for thyroid cancer; inflammation and preneoplastic lesions in benign prostate as risk factors for prostate cancer; and reclassification of serous ovarian carcinoma using a two-tier system.

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Steep climb to suitable reference standards

February 2013—It’s a long way from ancient Greek philosophers to modern-day clinical laboratory directors. Yet both types of scholars have one thing in common: the pursuit of truth. Socrates and his disciples thought of truth as correspondence to an objective universal ideal in the mind. Today’s clinical laboratory scientists need a more concrete standard against which to measure their results, leading to the continuing search for suitable reference materials to be used in method development, test validation, internal QC, assay calibration, and proficiency testing.

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Twilight zone for CVD risk markers?

February 2013—Times are tough all over. For the middle class, for newspapers, for François Hollande and his fellow French Socialists. Consider adding cardiac risk markers to that list. Despite decades of research and clinical experience, the marker conversation—what to measure, how, in whom—has become more an endless loop than a solid lineup. Old standbys still turn up in studies of novel markers, and tests that have arguably outlasted their usefulness still adhere, like barnacles, to laboratory menus. Some observers are even questioning the tenets of risk assessment.

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Latest anticoagulants—nuts and bolts for labs

February 2013—The list of anticoagulants has grown in recent years, which means there’s more to know about whether, when, and how to monitor. Last month in CAP TODAY, Michael Laposata, MD, PhD, spoke briefly about the newer drugs and explained how the older ones—warfarin, heparin, and low-molecular-weight heparin—work, and what that means for labs. This month, he returns to the newest of the major anticoagulants.

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From the President’s Desk: Transformational practice—2 in spotlight

February 2013—A National Football League playoff game was on the ceiling monitor in the airport lounge where I was trying to work on this column, and the announcer was talking about how well they were moving the ball. My first reaction was that he sounded awfully excited for a guy with only one ball to move. Maybe he should come to work at the CAP and see what real excitement is.

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AMP case report: Multilocus sequencing for rapid identification of molds

February 2013—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers, starting this month. AMP members will write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, treatment, and more. We aim to publish a few a year. The first such report comes from the University of Washington Medical Center, Seattle. (If you would like to submit a case report, please e-mail the AMP at amp@amp.org. For more information about the AMP, visit www.amp.org.)

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Hemolysis—can better processes add up to millions?

February 2013—If anybody is a believer in programs to reduce hemolysis rates in the hospital, it’s Dennis Ernst, MT(ASCP), director of the Center for Phlebotomy Education. Ever since he left the bench 15 years ago, Ernst has been traveling the country with a mission: to show clinical laboratories, nursing departments, hospital administrators, and clinicians that the payoff from high-quality phlebotomy is much greater than they might realize. Despite hemolysis being the No. 1 reason the laboratory rejects blood specimens, hemolysis does not strike randomly, and it’s not inevitable, Ernst emphasizes. “Typically the causes of hemolysis are all behavioral,” he says.

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AP tracking: an eagle eye on blocks and slides

February 2013—A high-tech blend of hall monitor, bloodhound, and lost and found, tracking systems to manage tissue specimens, blocks, and slides have gradually been taking root as part of an automated workflow in some anatomic pathology laboratories. As manual labeling, logging, and data capture give way to bar coding and even radio frequency identification, it’s a revolution of sorts, but a quiet one.

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Anatomic pathology systems product guide

February 2013—In the market for an anatomic pathology system? Check out the 27 AP offerings from 24 vendors. The systems profiled in this annual product guide are commercially available in the United States. In this year’s lineup for the first time is information pertaining to whether vendors provide a list of client sites to potential customers on request.

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Clinical Pathology Selected Abstracts, 2/13

February 2013—Outcome of patients who refuse transfusion after cardiac surgery: Jehovah’s Witness patients may refuse blood transfusion, due to religious beliefs, following cardiac surgery. Strategies to conserve blood for such patients may include the preoperative use of erythropoietin, iron, and B-complex vitamins, as well as hemoconcentration; intraoperative use of antifibrinolytics and cell-saver and smaller cardiopulmonary bypass circuits; and tolerance of low hematocrit levels postoperatively.

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Anatomic Pathology Selected Abstracts, 2/13

February 2013—BRCA1 and BRCA2 mutations, TP53 abnormalities, and immune cell infiltrates in ovarian carcinoma; Significance of loss of ARID1A/BAF250a expression in endometriosis; Relationship between pathologic complete response and prognosis after chemotherapy in breast cancer subtypes; Determining HER2 status on breast core-needle biopsies; Use of MiTF in differentiating cellular neurothekeoma from plexiform fibrohistiocytic tumor; A study of genetic heterogeneity in HER2/neu testing by FISH

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Newsbytes, 2/13

February 2013—Subspecialty no more—integrating informatics; PathCentral sells diagnostic laboratory business; ONC asks labs about health information exchange; EMR module from Psyche addresses meaningful use; NetLims to release new version of lab system; Online database addresses meaningful use measures

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Put It on the Board, 2/13

February 2013—An estimate of specimen identification error; Cepheid CT/NG test classified as moderate complexity; ARUP to offer Oncimmune early-stage lung cancer test; Hologic test cleared for detecting GI pathogens; IntelligentMDx to develop tests for Qiagen platform; Latest lab vacancy data in

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Q & A Column, 2/13

February 2013—What are the limitations of using myoepithelial markers in diagnostic breast pathology? Immunohistochemical studies using antibodies to highlight myoepithelial cells (MEC) can be useful adjuncts to traditional morphologic diagnosis in the practice of breast pathology. Antibodies commonly used to detect MEC include smooth muscle actin, calponin, smooth muscle myosin heavy chain, p63, CD10, cytokeratin 5/6, and p75, and each shows varying sensitivity and specificity.

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Rx for optimizing rapid flu test performance

January 2013—With the arrival of another flu season—this one early and intense—rapid influenza diagnostic tests (RIDTs) are once again occupying many laboratory directors’ minds. But although laboratories have found RIDTs useful for the last decade, evaluations of the test kits’ performance have been limited to manufacturers’ product inserts and a few small-scale studies. Like swing shift and day shift workers in the hospital, RIDTs have not been brought together for an assessment side by side.

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How anticoags work, and what that means for labs

January 2013—When to monitor and how? These questions were simpler when the list of anticoagulants patients were given was two or three deep—warfarin and unfractionated heparin, and maybe low-molecular-weight heparin. But the number of anticoagulants has grown and so has the complexity. Old and new—Michael Laposata, MD, PhD, covered the major anticoagulants and antiplatelet drugs in a recent AACC webinar and again at the CAP ’12 annual meeting in September. Here, this month, is an edited transcript of what he said in the webinar about warfarin and heparin and briefly about the newer drugs. In the February issue: a close-up look at fondaparinux, bivalirudin, rivaroxaban, dabigatran, lepirudin, and argatroban.

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New push to strengthen interim self-inspections

January 2013—Unless you have a full-time custodial staff at home, you have the same small annoyances around the house that nearly everyone has. Perhaps it’s a patchy paint job in the upstairs hallway. A closet light that burned out long ago. A dishwasher that periodically leaks. All things that visitors might not know about, but you do. And all things you’ve likely learned to live with in lieu of fixing.

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Building the case for PGx testing

January 2013—Mammals have a striking range of gestation periods, from the 12 days and 31 days of the opossum and rabbit to the 266 days and 360 days of the human and whale. Laboratory tests, too, take shorter or longer amounts of time to be delivered into routine clinical practice, with pharmacogenomics beginning to look like the elephant—more than 600 days’ gestation—of laboratory testing. Our first major discussion of this topic was in 2005, and the clinical pathology world had been “expecting” its arrival for some time before that.

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Cytopathology and More | Endometrial cells in Pap tests—when are they significant?

January 2013—Use of the Papanicolaou test has significantly decreased the incidence of cervical carcinoma, especially cervical squamous cell carcinoma. For endometrial adenocarcinoma, which is the most common malignancy of the gynecologic tract there is no cost-effective screening test. The Bethesda system 2001 recommends reporting normal endometrial cells in women 40 years or older and any atypical endometrial cells under the atypical glandular cells category.

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Newsbytes, 1/13

January 2013—Obtaining buy-in for an information systems buy; 2012 Best in KLAS Awards: Siemens laboratory system a winner once again; Apollo and ClearData team up on cloud-based offering; Alternative meaningful use criterion for reporting laboratory results; HHS posts information on mobile device security

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