Home >> ALL ISSUES >> 2015 Issues

2015 Issues

For pathologists, 8% aggregate hike in Medicare pay

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

Read More »

Clinical Pathology Abstracts, 12/15

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

Read More »

Anatomic Pathology Abstracts, 12/15

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

Read More »

Newsbytes, 12/15

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

Read More »

Prostate biopsy’s role in active surveillance

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

Read More »

Latest HbA1c debate examines race as nonglycemic factor

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

Read More »

Guide to urinalysis instrumentation

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

Read More »

A step-by-step process to 95% autoverification

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

Read More »

Multiplex PCR test for detection of enteropathogens in an infant

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

Read More »

3 new NGS Surveys on CAP 2016 PT launchpad

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

Read More »

Molecular Pathology Selected Abstracts, 11/15

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

Read More »

For proven natriuretic peptides, still much to be learned

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

Read More »

Leveraging urinalysis for value-based health care

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

Read More »

28 given awards for notable and longtime service

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

Read More »

Anatomic Pathology Abstracts, 11/15

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

Read More »

Put It on the Board, 11/15

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

Read More »

Newsbytes, 11/15

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

Read More »

Q&A column, 11/15

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

Read More »

Clinical Pathology Abstracts, 11/15

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

Read More »

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

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

Read More »

Analyze this: data shines within and without

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

Read More »

Put It on the Board, 10/15

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

Read More »

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

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

Read More »

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

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

Read More »

Automated molecular platforms — the latest on two dozen

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

Read More »

Groups urge phase-in of RHD genotyping

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

Read More »

Newsbytes, 10/15

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

Read More »

Clinical Pathology Abstracts, 10/15

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

Read More »

Anatomic Pathology Abstracts, 10/15

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

Read More »

Molecular Pathology Selected Abstracts, 10/15

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

Read More »

For now, first still last in primary HPV testing

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

Read More »

At the AACC Show 2015

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

Read More »

Q&A column, 9/15

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

Read More »

Molecular Pathology Selected Abstracts, 9/15

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

Read More »

Clinical Pathology Abstracts, 9/15

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

Read More »

Newsbytes, 9/15

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

Read More »

Put It on the Board, 9/15

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

Read More »

Anatomic Pathology Abstracts, 9/15

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

Read More »

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

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

Read More »

In vivo microscopy checklist ready when labs are

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

Read More »

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

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

Read More »

Trials show no benefit from fresher red cells

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

Read More »

From the President’s Desk: Partnerships for patients

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

Read More »

Integrating AP and radiology, inch by inch

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

Read More »

Q&A, 8/15

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

Read More »

Pay is up in Medicare proposal, but final picture unknown

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

Read More »

What’s new in next-gen sequencing checklist requirements

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

Read More »

Checklists 2015: signposts are clarity, consistency

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

Read More »

Letters, 08/15

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

Read More »

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

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

Read More »

Laboratory automation: more than moving from here to there

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

Read More »

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

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

Read More »

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

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

Read More »

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

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

Read More »

Lab studies new steps in urine and anemia screening

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

Read More »

IOM report on diagnostic errors expected this fall

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

Read More »

Clinical Pathology Abstracts, 8/15

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

Read More »

Anatomic Pathology Selected Abstracts, 8/15

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

Read More »

Molecular Pathology Selected Abstracts, 8/15

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

Read More »

Put It on the Board, 8/15

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

Read More »

Newsbytes, 8/15

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

Read More »

Put it on the Board, 7/15

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

Read More »

Anatomic Pathology Selected Abstracts, 7/15

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

Read More »

Newsbytes, 7/15

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

Read More »

Paths to validating next-gen sequencing assays

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

Read More »

For CKD, work is on to refine and find biomarkers

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

Read More »

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

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

Read More »

Business analytics insight within easy reach

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

Read More »

In genetics, stay open to the unexpected

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

Read More »

Evidence drives guideline on reducing interpretive error

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

Read More »

New lab, new efficiencies: doors open at Geisinger

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

Read More »

Q&A column, 7/15

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

Read More »

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

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

Read More »

Anatomic Pathology Selected Abstracts, 6/15

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

Read More »

Clinical Pathology Selected Abstracts, 6/15

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

Read More »

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

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

Read More »

Newsbytes, 6/15

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

Read More »

For viral diagnosis, metagenomic NGS

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

Read More »

New guideline spells out IPMN essentials

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

Read More »

Pharma strives to aid companion diagnostics

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

Read More »

MALDI in microbiology: Set to stun?

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

Read More »

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

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

Read More »

Letters, 5/15

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

Read More »

Labs solve price, space squeeze to welcome TLA

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

Read More »

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

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

Read More »

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

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

Read More »

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

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

Read More »

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

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

Read More »

Q&A column, 5/15

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

Read More »

Anatomic Pathology Selected Abstracts, 5/15

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

Read More »

Clinical Pathology Selected Abstracts, 5/15

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

Read More »

Molecular Pathology Selected Abstracts, 5/15

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

Read More »

Newsbytes, 5/15

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

Read More »

Pressing questions in POC glucose testing

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

Read More »

Put It on the Board, 4/15

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

Read More »

Anatomic Pathology Selected Abstracts, 4/15

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

Read More »

Molecular Pathology Selected Abstracts, 4/15

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

Read More »

Newsbytes, 4/15

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

Read More »

Q&A column, 4/15

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

Read More »

Nothing peripheral about assessing the ‘other’ cytopenias

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

Read More »

Workflow, regulatory unknowns tax molecular IT

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

Read More »

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

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

Read More »

At St. Jude, preemptive PGx tests guide prescribing

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

Read More »

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

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

Read More »

Groups closing the gap in reference materials for sequencing assays

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

Read More »

Genetic profiling vies with IHC in retune of CUP testing

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

Read More »

With molecular MPN testing, think positive

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

Read More »

Paths to validating, using urine sediment analyzers

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

Read More »

Hear me now? Another audition for speech recognition

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

Read More »

Q&A column, 3/15

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

Read More »

Newsbytes, 3/15

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

Read More »

Clinical Pathology Selected Abstracts, 3/15

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

Read More »

Anatomic Pathology Selected Abstracts, 3/15

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

Read More »

Put It on the Board, 3/15

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

Read More »

Put It on the Board

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

Read More »

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

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

Read More »

Trials for errors: how one lab fixed reporting flaws

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

Read More »

Anatomic Pathology Selected Abstracts, 2/15

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

Read More »

Q&A column, 2/15

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

Read More »

Newsbytes, 2/15

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

Read More »

Interface validation: abort, retry, succeed

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

Read More »

Clinical Pathology Selected Abstracts, 2/15

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

Read More »

Makeovers smarten core labs’ quality control

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

Read More »

The inside track in AP automation: new product guide

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

Read More »

Diagnostic perils of hematologic illness

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

Read More »

Liver donor organ evaluation

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

Read More »

Cytopathology and More | Automated screening workload limits are too high

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

Read More »

Anatomic pathology ‘practitioner’? Emerging roles for the cytotechnologist

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

Read More »

Medical genetics labs shine in 10-year proficiency test data

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

Read More »

Coagulation analyzers: Recently released and soon to be seen

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

Read More »

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

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

Read More »

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

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

Read More »

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

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

Read More »

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

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

Read More »

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

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

Read More »

Molecular Pathology Selected Abstracts, 1/15

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

Read More »

Anatomic Pathology Selected Abstracts, 1/15

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

Read More »

Put It on the Board, 1/15

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

Read More »

Labs entering risky payment game in the new year

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

Read More »

Transplant pathology atlas practical and to the point

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

Read More »

Newsbytes, 1/15

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

Read More »
CAP TODAY
X