Home >> ALL ISSUES >> 2016 Issues

2016 Issues

Procalcitonin passes automation hurdle

December 2016—Matt Damon in Interstellar. Julia Roberts in The Player. Gene Hackman in Young Frankenstein. When movie stars appear in uncredited parts, it’s usually for a cameo, not a leading role. But in diagnostics, an uncredited or off-label use of an assay might be its main use—possibly even its most clinically important use.

Read More »

Highs, lows of immune checkpoint inhibitors

December 2016—Barry Nelson was the first in his cancer patient support group to undergo immunotherapy, which at the time was in a phase one clinical trial at Dana-Farber Cancer Institute. As the therapy became available to others in his group, they would ask for his advice on whether to try it. For the answer, he’d suggest they consult with their doctors and pray. He’d add, “I hope if you decide to go with it that you’ll have the same results that I do.”

Read More »

Lymphoid neoplasms: Steven Swerdlow on classification revisions

December 2016—In his CAP16 talk, “Lymphoma Diagnosis and Classification: My Search for the Holy Grail,” Steven H. Swerdlow, MD, acknowledged that the quest has been long and contentious and the resulting classification complex. Why, he asked, is lymphoma classification so complex? It reflects an explosion of knowledge about the immune system and lymphomas and an increasing number of therapeutic targets requiring increasingly precise diagnoses. In other words, it reflects the complexity of the disease itself. As oncologist Alan C. Aisenberg, MD, PhD, wrote in 1995, “The complexity of non-Hodgkin’s lymphoma reflects the complexity of the lymphoid system.”

Read More »

Is the value of hospital lab outreach underrated?

December 2016—Hospitals across the nation have been selling their laboratory outreach operations to national laboratories, which have been snapping them up from community hospitals and larger enterprises. Take Henry Mayo New-hall Hospital in California (LabCorp) and Hartford HealthCare in Connecticut (Quest Diagnostics) this year, for example, and MemorialCare in California (Quest) in 2015.

Read More »

Medicare revises 2017 discount on add-on codes: Increases professional, cuts technical, pay for prostate biopsies

December 2016—Overall Medicare reimbursement for some professional pathology services will rise in 2017 due to increases sought by the CAP for add-on codes and other services provided by pathologists to Medicare beneficiaries. At the same time, the Medicare program will move forward with cuts affecting the technical component of pathology services, including flow cytometry, due to a targeted revaluation mandated by federal law.

Read More »

New protocols on deck as pathology helps reshape cancer staging

December 2016—It’s a familiar campus lament. New editions of textbooks in some academic fields have become notorious for providing little more than a few extra paragraphs of text or a few more references and altered pagination—mainly, students suspect, to serve as a damper on the textbook resale market. What is happening with a key text in the field of cancer care, however, is in marked contrast. The changes contained in the 8th edition of the AJCC Cancer Staging Manual of the American Joint Committee on Cancer, slated to take effect Jan. 1, 2018, are the opposite of cosmetic.

Read More »

AMP case report: Isolated hepatic neuroendocrine tumor expressing albumin mRNA and arginase-1, December 2016

December 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Pittsburgh Medical Center.

Read More »

What molecular diagnostics laboratory systems offer

December 2016—As personalized and predictive medicine have progressed from not-in-my-lifetime to now available, health care information technology vendors have faced the challenge of how to manage a mass of molecular data and direct molecular testing processes. CAP TODAY asked vendors of molecular diagnostics lab information systems to explain what their products contribute to the flourishing field of molecular testing. Here are their responses.

Read More »

Recent approvals and the pipeline

December 2016—Pembrolizumab (Keytruda) is now FDA approved as monotherapy for patients with untreated metastatic NSCLC, both squamous and nonsquamous histologies, that express PD-L1 at a high level of 50 percent or more, says Dr. Roger Dansey, who headed up Keytruda development at Merck Research Laboratories. “We do not have data at this point that would say whether a cutpoint lower than 50 percent in the first-line setting would be of equal value in terms of response to Keytruda,” he says.

Read More »

Molecular Pathology Selected Abstracts, 12/16

December 2016—ANXA1 as a predictive biomarker for resistance to trastuzumab in breast cancer: Treatment with the HER2-targeting antibody trastuzumab (Herceptin) is a key component of therapy for women with HER2-positive breast cancer. However, a subset of women with advanced disease shows initial or acquired resistance to therapy, although the mechanisms that control this resistance are largely unknown. Some studies have suggested that activation of the PI3K/mTOR signaling pathway may be responsible for trastuzumab resistance.

Read More »

Anatomic Pathology Abstracts, 12/16

December 2016—Reproducibility of NEPTUNE descriptor-based scoring system with various types of images: The multicenter Nephrotic Syndrome Study Network, or NEPTUNE, digital pathology scoring system uses a novel and comprehensive methodology to document pathologic features from whole-slide images, immunofluorescence, and ultrastructural digital images.

Read More »

Clinical Pathology Abstracts, 12/16

December 2016—Process optimization to improve immunosuppressant drug testing turnaround time: The routine use of immunosuppressant medications is critical for patients receiving solid organ transplants. Monitoring immunosuppressant (ISP) drug concentrations helps guide safe and effective dosing. ISP drug monitoring is performed using mass spectrometry or immunoassay methods.

Read More »

Q&A column, 12/16

Q. Are there guidelines on microsatellite instability analysis by immunohistochemistry on colorectal adenocarcinomas? Specifically, should immunohistochemical stains for the mismatch repair enzymes be performed on all colorectal adenocarcinomas regardless of the clinical or pathological findings? A medical group recently requested these studies on all colorectal adenocarcinomas.

Read More »

Newsbytes, 12/16

December 2016—The benefits of building a dedicated LIS support team: Too many cooks in the kitchen may be a problem, for which building more than one “kitchen” may be a solution. That’s the message Kathy Davis, manager of pathology informatics at the University of Michigan Medical Center, conveyed in an LIS management presentation at the 2016 Pathology Informatics Summit.

Read More »

From the President’s Desk: Where we direct our gaze

December 2016—I gave a talk for the CAP16 House of Delegates in September that opened with a three-minute video showing how perspective can change along a continuum of distance. The clip depicts a logarithmic journey across space from a grassy field in downtown Chicago to the farthest reaches of outer space, then retraces and extends its path to the deepest interior (“inner space”?) of human cells. That would be mesmerizing even without the stirring—almost danceable—orchestral accompaniment. The overall effect is visually stunning and intellectually provocative. I have watched the video a number of times. It never fails to remind me that where we stand and how we focus our attention really do shape what we see and how we see it.

Read More »

Sequencing goes deep to find rubella in uveitis patient

November 2016—Metagenomic deep sequencing, or MDS, has scored another coup in the diagnosis of an unexplained disease in a patient who had already had extensive workup with all other available tools. MDS had been used in 2014 to detect unsuspected leptospirosis in a critically ill encephalitis patient, enabling appropriate treatment and full recovery. Now some of the same clinical scientists at the University of California San Francisco Medical Center who helped diagnose that patient have identified rubella virus infection in the eyes of a patient with bilateral chronic intraocular uveitis that had been misdiagnosed as idiopathic inflammation for 16 years.

Read More »

Big hopes, bigger questions with PD-L1

November 2016—Progress is a complicated minuet. One popular adage talks of “one step forward, two steps back,” which is not only discouraging but, in an even less-gleaming light, happens to be the title of one of Vladimir Lenin’s books, published in 1904. A more optimistic version (and one less centered on the crisis facing communists in turn-of-the-century Russia) suggests advances occur with two steps forward, mitigated by only one step back.

Read More »

AMP case report: Detection of cnLOH as a sole abnormality in the diagnosis of myelodysplastic syndrome, November 2016

November 2016—Copy neutral loss of heterozygosity (cnLOH) is an acquired abnormality found in patients with cancer and hematologic disorders and can be detected by molecular techniques such as PCR-based analyses and hybridization-based chromosome genomic array testing (CGAT). We report a case in which cnLOH was the sole abnormality detected by CGAT in a patient with myelodysplastic syndrome. This case illuminates the importance of utilizing CGAT results, namely cnLOH findings, as one of the primary diagnostic indicators in order to expedite initial therapies.

Read More »

Anatomic Pathology Abstracts, 11/16

November 2016—Relevance of papillary growth patterns of pulmonary adenocarcinoma, HPV involvement in head and neck cancers: assessment of biomarkers, Distinctive immunoregulatory microenvironment of medullary carcinoma of the colon, Diagnostic challenges caused by endoscopic biopsy of colonic polyps, MicroRNA expression profiling and expression of miR-205 in inflammatory breast cancer

Read More »

Clinical Pathology Abstracts, 11/16

November 2016—Neonatal ICU quality initiative: identifying preanalytical variables that contribute to specimen hemolysis: Hemolysis is a major cause of sample rejection and the need to recollect a specimen from a patient. In the neonatal intensive care unit, this may be of particular concern because of limited venous access and the risk of causing iatrogenic anemia.

Read More »

Molecular Pathology Selected Abstracts, 11/16

November 2016—Misclassification of genetic variants associated with hypertrophic cardiomyopathy: Hypertrophic cardiomyopathy has a variable clinical presentation and may lead to sudden cardiac death. In many cases, it is associated with pathogenic genetic variants, enabling screening of relatives and, possibly, the ability to individualize treatment strategies through lifestyle modification or invasive procedures.

Read More »

In memoriam: Tyra T. Hutchens, MD | 1921–2016

November 2016—Tyra T. Hutchens, MD, who served as CAP president from 1977 to 1979, died Aug. 28 at age 94. Dr. Hutchens was CAP vice president from 1975 to 1977 and a member of the Board of Governors from 1968 to 1974. He was a member of the Executive; Standards; and Budget, Planning and Review committees and of the Council on Government Relations and Liaison and the CAP History Editorial Board.

Read More »

Shorts on Standards, 11/16

November 2016—The Laboratory Working Group of the National Kidney Disease Education Program and the IFCC Working Group for Standardization of Albumin in Urine are collaborating with IVD manufacturers to improve standardization of commercial measurement procedures. Urine albumin is an important biomarker for kidney damage.

Read More »

Q&A column, 11/16

November 2016—As originally described, there are technically five Gleason patterns: 1, 2, 3, 4, 5. However, since patterns 1 and 2 are never used, there are no Gleason scores 1 + 1 = 2, 1 + 2 = 3, 2 + 1 = 3, 2 + 2 = 4, 2 + 3 = 5, and 3 + 2 = 5. Why is this? Isn’t this an alteration of Gleason’s original classification concept? Furthermore, there are cases in which a biopsy may contain a few glands that are diagnostic of carcinoma but insufficient to assign an accurate Gleason score. Would it simply be best to make a descriptive comment to that effect?

Read More »

Newsbytes, 11/16

November 2016—How a pathology website can help build pathology websites: What if one could Google “biopsy orientation processing cassette” and receive detailed methodological instruction in surgical pathology as easily as finding a recipe for pound cake? Izak B. Dimenstein, MD, PhD, HT(ASCP), a grossing technologist retired from Loyola University Chicago Medical Center, believes highly specific information about laboratory methodologies should be easily accessible on the Web.

Read More »

AMP case report: October 2016 test yourself answers

November 2016—In the October 2016 issue was a report, “Laser capture microdissection: Vanishing roles in tissue microdissection revalued in salvaging a melanoma with micrometastasis for BRAF V600E mutation detection,” written by members of the Association for Molecular Pathology. Here are answers (in bold) to the three “test yourself ” questions that followed that case report.

Read More »

Labs enter a MALDI-TOF state of mind

October 2016—When MALDI-TOF mass spectrometry enters the microbiology lab, it’s a little like watching Sir John Falstaff settle his considerable girth onstage. Things happen. Characters fret and flee, scheme, opine, panic, and, in the case of Prince Hal, ascend to greatness. (And, if we’re honest, some just get drunk.) Both, in brief, are an upending presence.

Read More »

Blood bank: On guard against daratumumab interference

October 2016—As fans of spycraft know, offensive counterintelligence can include an arsenal of strategies: initiating a diversion, sowing confusion, creating false identities—anything that makes another party believe something that isn’t true. If the cancer treatment drug daratumumab were capable of deceptive intent, it might be accused of all those ploys when it comes to interfering with blood transfusion crossmatching. The reason: For patients receiving daratumumab, marketed as Darzalex by Janssen Pharmaceuticals, antibody testing for transfusion is subject to erratic false-positives, often leaving transfusion services confused, uncertain, and on hold.

Read More »

The President’s Desk: How clarity can bridge our silos, 10/16

October 2016—I had been looking forward to Cancer Biomarkers Conference II at Houston Methodist Hospital, even though early September wasn’t the best time to travel. Work was busy and CAP16 was only two weeks away. During the weekend meeting, I rediscovered the value of stepping back from business as usual. The program was fast-paced and stimulating, and I learned a lot. Even the nonpathologists I met clearly appreciated what I shared about how much pathologists do to facilitate the adoption of these new diagnostic tools.

Read More »

Yale researchers dig for new kidney biomarkers

October 2016—An automated immunoassay has been created for symmetric dimethylarginine, or SDMA, a biomarker that can detect chronic kidney disease between 10 to 17 months earlier than creatinine, with 100 percent sensitivity and 91 percent specificity. And, unlike with creatinine, a patient’s muscle mass does not influence the biomarker’s reliability.

Read More »

AMP case report: Laser capture microdissection: Vanishing roles in tissue microdissection revalued in salvaging a melanoma with micrometastasis for BRAF V600E mutation detection, October 2016

October 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Florida College of Medicine, Jacksonville.

Read More »

CAP16: All-star team presented with CAP and Foundation awards

October 2016—Gene N. Herbek, MD, was presented Sept. 25 with the Pathologist of the Year award during the spotlight event at the CAP16 annual meeting in Las Vegas. At the same event, Cordelia E. Sever, MD, was given the Pathology Advancement award, Sang Wu, MD, the CAP Foundation Gene and Jean Herbek Humanitarian award, Carey Zimmerman August, MD, the Outstanding Communicator award, and Denise K. Driscoll, MS, MT(ASCP)SBB, the CAP Staff Outstanding Achievement award.

Read More »

When pain management testing calls for a consult

October 2016—Surprises might work for birthday parties—and even then they’re not everyone’s cup of tea—but not in drug screening programs. Perhaps the most common reason for doing a toxicology consultation is when a urine drug screen yields an unexpected result, either positive or negative, says Nicholas Heger, PhD, assistant director of clinical chemistry at Tufts Medical Center and assistant professor of anatomic and clinical pathology, Tufts University School of Medicine, Boston.

Read More »

Anatomic Pathology Abstracts, 10/16

October 2016—Features of columnar-lined esophagus in gastroesophageal junction biopsies; Significance of Paneth cells in histologically unremarkable rectal mucosa; MicroRNA expression profile related to lymph node status in endometrial cancer; Plasma cells in melanoma: prognostic significance and possible role of IgA; Human epidermal growth factor receptor 2 testing in invasive breast cancer

Read More »

Clinical Pathology Abstracts, 10/16

October 2016—Risk factors for transfusion in cesarean section deliveries at a tertiary hospital: Obstetrical hemorrhage is a major cause of morbidity and mortality in young women and may be difficult to predict. In some regions of the world, postpartum hemorrhage (PPH) may account for up to 25 percent of maternal deaths. Many studies have focused on the predictors of PPH before delivery.

Read More »

Q&A column, 10/16

October 2016—What are the guidelines for proper handling and processing of blood specimens collected in serum separator tubes? Are there regulations guiding the practice of taking additional blood samples from a patient even though there are no orders for the blood samples? These “just in case” specimens are sent to our laboratory by the emergency department when a port or catheter is placed in the patient. The ED’s reasoning is that it prevents a patient from being stuck twice if there is an order for blood tests later. Our lab has to either store the samples or process them (centrifuge or separate RBCs from serum) so they are ready in case an order is entered later. Should this practice be banned? Should we refuse to accept these samples?

Read More »

Newsbytes, 10/16

October 2016—Process improvement software more than online suggestion box; Viewics launches analytics tool for diabetes management; Hc1.com joins forces with Experian Health; OptraScan introduces whole slide imaging scanner; Contracts and installations

Read More »

Put It on the Board

October 2016—Cancer Moonshot has diagnostic thrust: Vice president Joe Biden’s Cancer Moonshot now has a flight plan, drafted by a blue-ribbon panel and published in September. Coming as it does in the final year of president Obama’s term in office, there are doubts about whether the ambitious $1 billion program—aimed at achieving 10 years’ progress in cancer research and treatment in a five-year period—will ever get off the launching pad.

Read More »

Beauty fad’s ugly downside: test interference

September 2016—It’s the kind of health promotion advice one might pick up casually over lunch with friends, in a quick Google search, or during a visit to the hairdresser. Take megadoses of an over-the-counter vitamin called biotin—a common supplement in multivitamin compounds—and watch your skin improve and your hair and nails thicken and gleam. In recent years, online social networks and health-related websites have begun to teem with ads claiming that people have seen a transformation since they jumped on the biotin bandwagon.

Read More »

From the President’s Desk: In the eye of the brainstorm, 9/16

September 2016—Radiolab is a radio show and podcast about (mostly) scientific curiosities co-hosted by a perpetually interested guy who majored in music. You might describe it as a talk show for science geeks. These are people who know how to ask the right questions and put the answers in context. A recent installment (“Colors”) questions whether color is a concrete characteristic of the physical world or simply a mental overlay we apply to our perception. Early on, you learn that a young Isaac Newton pursued the mechanism of color perception by piercing his own eye with a knife. I was hooked.

Read More »

Mass spec up front for pain management testing: Interest growing in oral fluid testing as alternative to urine testing

September 2016—This fall, Brigham and Women’s Hospital, Boston, is taking the mass spec leap. A plucky PR person might be tempted to refer to it as MassSpec LEAP!™ but Stacy Melanson, MD, PhD, doesn’t have time for such nonsense. As the associate director of clinical laboratories and co-director of chemistry, Dr. Melanson has more important matters to attend to. She and her colleagues are shifting from using a screening immunoassay for pain management drug testing to up-front definitive testing by LC tandem mass spectrometry.

Read More »

Laboratory accreditation program 2016 checklists: Less legwork, more clarity seen in personnel changes

September 2016—For the CAP Laboratory Accreditation Program, inspection checklist requirements covering personnel are a perennial concern. They are the leading source of disparities between the findings of the program’s inspectors and inspection audits done by the Centers for Medicare and Medicaid Services. Personnel is also high on the list of questions asked of Laboratory Accreditation Program staff. “Personnel is a hot topic for the College,” says CAP Checklists Committee chair William W. West, MD.

Read More »

New from CAP Press: Inspired by pathology, connected through art

September 2016—When Ray Paul was diagnosed with sarcoma in 2011, he wanted to understand his disease. His neighbor was a resident in the radiation department at Moffitt Cancer Center, Tampa, Fla., where Paul was being treated, and that neighbor was happy to introduce him to the pathologist on Paul’s case. An artist and biologist, Paul told the pathologist: “‘I want to see what my tumor looks like. I want to stare my devil in the eye,’” recalls Marilyn M. Bui, MD, PhD, a senior member of the Departments of Anatomic Pathology and Sarcoma, section head of bone and soft tissue pathology, and scientific director of the analytic microscopy core, Moffitt Cancer Center, and a professor and cytopathology fellowship director, University of South Florida Morsani College of Medicine.

Read More »

Quizzed in Ansbach, then key to a drug trial for mast cell disease

September 2016—In December 2007, American hematopathologist Tracy I. George, MD, spent a weekend in the small town of Ansbach in central Bavaria in the laboratory of Hans-Peter Horny, MD, whom she calls “the father of mast cell pathology.” Dr. Horny was at that time a privately practicing hematopathologist after having spent most of his career in academia. Plans for an international clinical trial were underway to evaluate the investigational drug midostaurin in advanced systemic mastocytosis, a rare group of diseases for which there was no effective therapy, and Dr. Horny would be the study pathologist. Dr. George, who had been diagnosing mast cell diseases for several years, wanted to take part as well.

Read More »

Method or test? Providing clarity to clinicians on NGS

September 2016—Whether it was “This is your brain on drugs,” “Take a bite out of crime,” or “Friends don’t let friends drive drunk” popping up onscreen, few of us watching TV in the 1970s and ’80s enjoyed having our programs interrupted by those public service announcements. Yet those important messages stuck in viewers’ brains—and stuck hard, if homages such as the Washington Post’s “10 Best PSAs of All Time” are anything to go by.

Read More »

Anatomic Pathology Abstracts, 9/16

September 2016—Digital image analysis versus manual biomarker assessment in breast cancer; Clinical and cost impact of EGFR and ALK testing in early stage NSCLC; Switch/sucrose nonfermenting complex protein expression in an aggressive endometrial cancer; Immune microenvironment of breast ductal carcinoma in situ; Adverse histological features in malignant colorectal polyps; Use of ancillary molecular analysis for diagnosis of soft tissue tumors

Read More »

Molecular Pathology Selected Abstracts, 9/16

September 2016—Mutations causing acquired resistance to PD-1 blockade in melanoma: Immunotherapy in metastatic cancer has achieved durable responses in a wide variety of cancer types. Antibodies that block programmed cell death protein-1 (PD-1) are particularly effective in metastatic melanoma, but a recent study showed that approximately 25 percent of patients that achieved a durable response ultimately had disease progression at a median follow-up of 21 months.

Read More »

Q&A column, 9/16

September 2016—We know we can count fewer than 100 cells for a manual differential if there is a very low white cell count. But if the white cell count is very high, should we count more than 100 cells? Some references state that >30,000 WBC/µL require a 200 cell differential, others >50,000 WBC/µL, and many do not mention at all the need to increase above 100 cells counted.

Read More »

Newsbytes, 9/16

September 2016—Graph database technology: what it can do given the chance; Group seeks participants to help foreign labs meet needs; ONC tool grades C-CDA documents for interoperability; BBCS releases new version of ABO Express; Prototype device provides fast bacterial infection diagnosis; Voicebrook announces software installation

Read More »

Put It on the Board, 9/16

September 2016—AMP lays out clinical utility standard for molecular Dx: The Association for Molecular Pathology has published a 14-page report its leaders hope will reset the conversation payers, policymakers, and medical guideline panels have when assessing the clinical utility of molecular diagnostics in oncology and inherited diseases. The key to AMP’s approach is to broaden the standard for what is considered a clinically useful molecular diagnostic test.

Read More »

Add-ons, consults spared cuts in proposed fee schedule: Dip in revenue, many technical component codes in for a hit

August 2016—The proposed Medicare physician fee schedule for 2017 features a slight dip in overall revenue for pathology groups and independent laboratories, but payment for flow cytometry and the technical components of prostate biopsy and surgical pathology work could fall by double-digit percentages if the Centers for Medicare and Medicaid Services stands pat with its final rule later this year.

Read More »

Painstaking process of drug monitoring

August 2016—As optimists like to point out (in their annoying way), showing up is half the battle. But it’s still only half, as other, equally clear-eyed folks might point out. That leaves plenty to do. And in drug testing for chronic pain management, the work facing laboratories may seem like even more than 50 percent.

Read More »

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

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

Read More »

Cytopathology in Focus—Endoscopic ultrasound-guided FNA and core biopsy: Are we progressing to a best practice?

August 2016—Endoscopic ultrasound (EUS) is a safe and effective procedure for visualizing and screening for lesions within and in the vicinity of the upper gastrointestinal tract, liver, pancreas and peri-pancreatic lymph nodes, and soft tissues. In addition to the detection and imaging of these lesions, endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) allows for concomitant sampling of visualized lesions for tissue diagnosis.

Read More »

Cytopathology in Focus: The evolving management of LSIL in Pap tests

August 2016—The Bethesda System for Reporting Cervical/Vaginal Cytologic Diagnoses was developed to establish standardized terminology among pathologists for communicating to clinicians the findings of a Pap test.1 The Bethesda System has also facilitated the examination of the epidemiology and pathogenesis of cervical disease, with a focus on low-grade and high-grade squamous intraepithelial lesions (LSIL and HSIL, respectively) and their relationships to human papillomavirus infection and progression to invasive cervical carcinoma.

Read More »

ABP seeks volunteers to help shape next-generation MOC

August 2016—The American Board of Pathology has been selected to participate in the American Board of Medical Specialties’ Maintenance of Certification Assessment Initiative pilot. Currently, MOC Part III assesses a diplomate’s knowledge, judgment, and skills with a secure examination. The aim of the new initiative is to develop and test a new model for assessment that will be formative and summative.

Read More »

In situ hybridization: more harmony across checklists

August 2016—As the use of in situ hybridization (ISH) expands, laboratories employing this form of testing increasingly rely on the CAP Laboratory Accreditation Program checklist for guidance. That is one reason members from three CAP committees started meeting to revise the ISH checklist, says CAP Surgical Pathology Committee member Aleodor Andea, MD, MBA. Another reason: to harmonize and streamline the ISH checklist requirements across three different disciplines.

Read More »

A new case of severe hemophilia and Moyamoya (SHAM) syndrome

August 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Columbia University Medical Center. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

Read More »

Clinical Pathology Abstracts, 8/16

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

Read More »

Anatomic Pathology Abstracts, 8/16

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

Read More »

Molecular Pathology Selected Abstracts, 8/16

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

Read More »

Q&A column, 8/16

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

Read More »

Put It on the Board, 8/16

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

Read More »

For certain thyroid lesions, the shift is on

July 2016—Time was running out for Yuri Nikiforov, MD, PhD, vice chair for molecular pathology and division director of molecular and genomic pathology, University of Pittsburgh Medical Center. For nearly a year he had been working to assemble an international group of experts—pathologists, endocrinologists, a surgeon, and, unusually, a psychiatrist and a patient advocate—to discuss that most vexing of thyroid tumors, encapsulated follicular variant of papillary thyroid carcinoma, or EFVPTC.

Read More »

Laboratory 2.0: Changing the conversation

July 2016—Bundled payments, physician employment, and unconventional competitors are cannibalizing the volume-based business model that for decades has defined laboratory medicine. And labs have little room within their customary confines—the three percent of health system spending they directly account for—to play a central role in American medicine’s transformation.

Read More »

In C. diff and cardiac care, lab steps up decision support

July 2016—What’s the one way to win friends and influence people? If you’re Eugenio H. Zabaleta, PhD, the answer is simple: Reduce the number of stool samples nurses have to collect. A few years ago, Dr. Zabaleta, clinical chemist at OhioHealth Mans-field Hospital, introduced a clinical testing algorithm for C. difficile that cut the number of stool samples by almost 50 percent. “And the nurses are loooving me for it,” he says happily. “The joke is, when nursing and lab work together, there is literally less crap for everybody.”

Read More »

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

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

Read More »

A rare case of Diamond Blackfan anemia: identifying the causative mutation using NGS

July 2016—Diamond Blackfan anemia is a rare, inherited bone marrow failure syndrome manifesting as marked red cell aplasia and variable congenital anomalies. We report here a case of Diamond Blackfan anemia, which underscores the role of an integrated diagnostic workflow including hematopathologic evaluation and next-generation sequencing for establishing the diagnosis and potential management of rare, inherited bone marrow failure syndromes.

Read More »

In praise of the path less traveled: public health labs

July 2016—For those who crave variety in their work and have a penchant for the unusual, Paul Bachner, MD, has a career message: Don’t overlook public health. As medical director of the Division of Laboratory Services for Kentucky’s public health department from 2013 to July 2015, Dr. Bachner expected the unexpected, whether it was an outbreak of food contamination, a suspected case of Ebola, or a newborn with a life-threatening metabolic disorder.

Read More »

Poisoning, overdose: Better technology, workflow improve patient odds

July 2016—As pronouncements by fictional detectives go, one of the most famous is Sherlock Holmes’ declaration to Dr. Watson: “When you have excluded the impossible, whatever remains, however improbable, must be the truth.” Unfortunately, Holmes’ advice is no practical rule of thumb for solving the real-world mysteries of patient poisoning or overdose, because the possibilities are often so vast.

Read More »

Clinical Pathology Abstracts, 7/16

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

Read More »

Molecular Pathology Selected Abstracts, 7/16

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

Read More »

Newsbytes, 7/16

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

Read More »

Q&A column, 7/16

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

Read More »

Put It on the Board, 7/16

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

Read More »

Clampdowns on out-of-network billing climb

June 2016—To the average reader, “out-of-network billing” might seem like a technical concept that should mainly concern hyperaware insurance wonks. Media outlets from NBC News to Time to the Huffington Post have found that phrases like “surprise medical bill,” “angry patients,” and sometimes “sticker shock” in recent stories are much more likely to grab attention.

Read More »

Glucose PT criteria reset stirs standards debate

June 2016—It may not be an exact science, but resetting standards is a long-established means of improving quality of testing, and it can also be a way of adapting to improvements in quality that have already been realized. In the case of the CAP’s recent tightening of proficiency testing criteria for hospital glucose testing, both purposes are at work.

Read More »

All for one, one for all? Laboratory consolidation

June 2016—Consolidation among hospitals and laboratories can sometimes seem like too massive a tide for independent and hospital-based laboratories to effectively resist. What are the advantages that large size provides to a hospital system or national lab in a competitive marketplace? And will there be any space left in which smaller laboratories can survive?

Read More »

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

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

Read More »

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

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

Read More »

More clarity over time for heart failure biomarkers

June 2016—Robert Christenson, PhD, a professor of pathology and of medical and research technology at the University of Maryland School of Medicine, likens the U.S. mortality rate for myocardial infarction to three or four jumbo jets crashing daily. For heart failure, it’s about half that many deaths, “so maybe one and one-half jumbo jets,” Dr. Christenson said in a session on cardiac biomarkers at the CAP annual meeting last year.

Read More »

On a quest for the eureka moment in Zika virus testing

June 2016—The Zika virus testing challenges facing laboratories are many, including the virus’ low and short-term viremia and its resemblance to other flaviviruses, especially dengue and chikungunya. “These viruses present extremely similarly, and it’s very difficult to tell them apart based on clinical characteristics alone,” said Benjamin Pinsky, MD, PhD, who presented the details of diagnostic tests for Zika in an Association for Molecular Pathology webinar in April.

Read More »

Antiphospholipid Antibodies

June 2016—CAP Press has released the second edition of its 2008 book, An Algorithmic Approach to Hemostasis Testing, edited by Kandice Kottke-Marchant, MD, PhD. She is chair of the Robert J. Tomsich Pathology and Laboratory Medicine Institute and section head of hemostasis and thrombosis, Cleveland Clinic Foundation.

Read More »

SS18-SSX2 fusion transcript in the diagnosis of a poorly differentiated synovial sarcoma

June 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from Penn State Milton S. Hershey Medical Center and Penn State College of Medicine. If you would like to submit a case report, please send an email to the AMP at amp@amp.org. For more information about the AMP and all previously published case reports, visit www.amp.org.

Read More »

Clinical Pathology Abstracts, 6/16

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

Read More »

Q&A column, 6/16

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

Read More »

Put It on the Board, 6/16

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

Read More »

Making a smooth pivot to point-of-care IQCP

May 2016—Practically speaking, there’s a limit to the number of balls a human can juggle. And there’s probably a limit to how complex a quality control plan a point-of-care testing coordinator can handle. Last year, many POC coordinators felt that the Centers for Medicare and Medicaid Services would be pushing that limit pretty hard with its new Individualized Quality Control Plan.

Read More »

Early days, early detection, early treatment for HIV

May 2016—In 1985, when the first test for HIV—then called human T-cell lymphotropic virus type III—became available, it was approved for screening blood products but not for diagnostic use. A diagnostic test for antibody to HIV-1 was soon approved. Over the subsequent 30-plus years, further iterations of HIV screening tests have been made, with increasing sensitivity and specificity and a shorter window to detection. Fifth-generation tests are now under review. CAP TODAY asked Eileen Burd, PhD, D(ABMM), to discuss the evolution of HIV diagnostics and algorithms for using them and to give a qualitative evaluation of the pending fifth-generation assay.

Read More »

Metastatic cancer of unknown primary: diagnostic challenges

May 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. Case report No. 11, which begins here, comes from Cooper Medical School at Rowan University and Cooper University Hospital, Camden, NJ.

Read More »

Heart biopsy the first step on a complex path

May 2016—The stories are haunting: a young, seemingly healthy athlete collapses on the playing field and dies. For Joseph Maleszewski, MD, section head of cardiovascular pathology, Mayo Clinic, Rochester, Minn., these deaths also seem sadly familiar, especially given his work with the NCAA on such cases. “Every community, it seems, has a story,” says Dr. Maleszewski, who is also associate professor, laboratory medicine and pathology, and associate professor, medicine. “A child died on the basketball court, on the football field, while running track. These young athlete deaths are not uncommon at all—or even young nonathlete deaths.”

Read More »

With high-sensitivity troponins, watching and waiting continue

May 2016—Laboratories and hospitals in the U.S. continue to look forward to high-sensitivity troponin assays. Judd E. Hollander, MD, says all he’s heard for the past five years is that an assay will be out at the end of the year. “And once you get halfway through the year, it will be out next year,” says Dr. Hollander, chair of the Department of Emergency Medicine and associate dean of strategic health initiatives at Sidney Kimmel Medical College of Thomas Jefferson University.

Read More »

FilmArray ME panel—clinical trial to 1st clinical test

May 2016—The BioFire FilmArray meningitis/encephalitis (ME) panel received FDA clearance last October, and in November Jennifer Dien Bard, PhD, D(ABMM), of Children’s Hospital Los Angeles, presented the results of the multicenter clinical evaluation of the panel, in a webinar produced by CAP TODAY in collaboration with BioFire. The panel’s use in the clinical setting will reduce turnaround time and may, pending further studies, have a positive impact on patient care and outcomes, said Dr. Dien Bard, director of the clinical microbiology and virology laboratories at Children’s Hospital LA.

Read More »

Cytopathology in Focus: Paris System: a new paradigm for urinary cytology

May 2016—The Paris System Working Group has proposed and published a standardized reporting system that redefines the primary purpose of urinary cytology: the detection of high-grade urothelial carcinoma (HGUC).1 A program to address standardization of urine cytology reporting was conceived at the 18th International Congress of Cytology in Paris in May 2013 where a number of people of like interest assembled and formed the Paris System Working Group.

Read More »

Cytopathology in Focus: Managing adults with thyroid nodules and cancer—2015 guideline highlights

May 2016—In January of this year, the American Thyroid Association published the 2015 update to its guidelines for the management of adults with thyroid nodules and differentiated thyroid cancer.1 Separate guidelines were published for the pediatric population in July 2015.2 Although the guidelines for adult patients were published as a “Special Article” in Thyroid, they run the length of a small book—133 pages in total.

Read More »

Cytopathology + More | Assessing needle core biopsy adequacy—survey of practices

May 2016—In the era of personalized medicine1 it is paramount to collect samples that will have sufficient material not only for an accurate diagnosis but also in many cases for prognostication or eligibility for targeted therapy or both. This may involve use of immunohistochemistry, flow cytometry, microbiological culture studies, and molecular studies. Fine needle aspiration and needle core biopsies (NCB) are used routinely for diagnosis of mass lesions from various sites in the body, and both FNA and/or cell blocks and NCB have been used successfully for these purposes.

Read More »

Clinical Pathology Abstracts, 5/16

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

Read More »

Anatomic Pathology Abstracts, 5/16

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

Read More »

Q&A column, 5/16

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

Read More »

Newsbytes, 5/16

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

Read More »

FilmArray GI: findings from first months of clinical use

April 2016—Treating Clostridium difficile can be dreadfully difficult, even when a clinician doesn’t have to navigate ordering restrictions based on testing frequency. So when Julie A. Ribes, MD, PhD, director of clinical microbiology at UK HealthCare in Lexington, Ky., received a phone call last year from a clinician who asked for repeat C. difficile testing, she was more than sympathetic.

Read More »

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

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

Read More »

IQCP without agony at the point of care

April 2016—For many point-of-care testing coordinators, the prospect of developing Individualized Quality Control Plans is far from enticing. But there has never been much chance that laboratories could opt out of the Centers for Medicare and Medicaid Services’ new quality control framework for much of their nonwaived testing.

Read More »

Next-gen sequencing workflow in full spate

April 2016—With next-generation sequencing’s clear benefits—for diagnosis, prognosis, treatment, and trials—come its new challenges, and clinical laboratories are doing what it takes and sharing how. Two plenary speakers at last year’s meeting of the Association for Molecular Pathology spoke of variant calling in the bioinformatic pipeline and validation, and of clinical reporting. Colin Pritchard, MD, PhD, of the University of Washington and one of the speakers, sees reporting a genomic sequencing assay as more like making a histologic diagnosis, which he calls craftwork, than reporting a sodium value. “That’s an idea that hasn’t really permeated yet,” he said.

Read More »

Diagnosing polycythemia vera: conventional tools amid molecular options—case report and brief review

April 2016—Case. The patient presented in May 2013 at age 42 with a two-year history of fatigue and pruritus of his legs. He smoked one pack of cigarettes per day as he had for 25 years and had about five to six alcoholic drinks daily. Physical exam was unremarkable with no rash or palpable splenomegaly. Height was 74 inches and weight 189 pounds.

Read More »

Prostate pointers—PIN, ASAP, mimics, and markers

April 2016—Presenting on prostate cancer diagnosis at CAP ’15 last fall, David G. Bostwick, MD, MBA, recalled how he and Kenneth A. Iczkowski, MD, came up with the term “atypical small acinar proliferation suspicious for but not diagnostic of malignancy,” or ASAP, when they were at Mayo Clinic in 1997. They had scoured the Mayo files trying to spot the right term because they didn’t know what to call it, said Dr. Bostwick, who is medical director of Granger Diagnostics in Richmond, Va. “Should we call it suspicious but not diagnostic? Should we call it worrisome? Problematic?” Dr. Bostwick joked that his favorite expression seen in the files as a prostate biopsy finding in the 1980s was “semi-malignant,” saying, “I still don’t know what that means.”

Read More »

The challenge of intraductal carcinoma of prostate

April 2016—In his CAP ’15 presentation last fall, David Bostwick, MD, MBA, referred to intraductal carcinoma of the prostate as “sort of the rage right now in the urologic pathology field.” “The problem is that it has multiple different definitions, and interobserver agreement with it is moderate at best,” said Dr. Bostwick, medical director of Granger Diagnostics in Richmond, Va. Even when pathologists can agree on an IDC diagnosis, he said, they aren’t on the same page about treatment.

Read More »

Anatomic Pathology Abstracts, 4/16

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

Read More »

Q&A column, 4/16

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

Read More »

Newsbytes, 4/16

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

Read More »

In memoriam: Thomas P. Wood, MD | 1929–2016

April 2016—Thomas P. Wood, MD, the 25th president of the CAP, died Feb. 15 at age 87. Dr. Wood was speaker of the House of Delegates from 1992 to 1995, president-elect from 1995 to 1997, and president from 1997 to 1999. He was a longtime member of the Professional Affairs Committee (which he also chaired) and the Council on Government and Professional Affairs, and he was a board director of the CAP Foundation for six years. In 2000, the CAP recognized him as Pathologist of the Year.

Read More »

Put It on the Board, 4/16

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

Read More »

Immunotherapy steers focus to microenvironment

March 2016—It’s not every day that a monoclonal antibody leads the news. But when former president Jimmy Carter was successfully treated for metastasized melanoma last year with the new drug pembrolizumab (Keytruda), the story made headlines. Carter’s recovery—surprising to many when it was announced in December—may have been helped by traditional radiation and chemotherapy. However, the role played by pembrolizumab spotlighted immunotherapy as an exciting advance in the evolution of cancer treatment.

Read More »

Cutting cultures: the move to all molecular in virology

March 2016—For laboratories performing virology testing, taking advantage of molecular testing’s superiority to traditional testing methods is a no-brainer. But leaders in the University of Michigan’s clinical microbiology laboratory have found that the push to go all molecular for virology testing must be tempered by attentiveness to clinician preferences and a collaborative approach that’s likelier to make the journey a success.

Read More »

Lab shoots for better phlebotomy service, satisfied patients

March 2016—Try running a race and tying your shoes at the same time. That is the kind of challenge laboratories face when they endeavor to refine their processes while providing all the usual services clinicians and patients expect. When laboratory leaders at Brigham and Women’s Hospital in Boston surveyed the landscape of their phlebotomy operations, they spotted many opportunities for improvement through Lean Kaizen events as well as technology that reduces the risk of human error.

Read More »

Anatomic Pathology Abstracts, 3/16

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

Read More »

Molecular Pathology Selected Abstracts, 3/16

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

Read More »

Clinical Pathology Abstracts, 3/16

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

Read More »

Q&A column, 3/16

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

Read More »

Liquid biopsy—much to do about something

March 2016—Lynette Sholl, MD, isn’t fully sold on that hottest of feverishly hot topics, liquid biopsy. “It’s kind of a sexy colloquialism, I suppose,” says Dr. Sholl, associate director, Center for Advanced Molecular Diagnostics, and associate pathologist, Brigham and Women’s Hospital, Boston. “Is there an official definition?”

Read More »

Broadening the productivity spectrum with middleware

March 2016—As James Beck, MT(ASCP), remembers it, middleware was introduced at his institution about the same time that the nursing department decided connectivity should be the province of the laboratory. When the concept of docking and interfacing glucose testing devices came on the scene around the turn of the millennium, that was a turning point, says Beck, who is point-of-care testing coordinator for the University of Pittsburgh Medical Center–St. Margaret, which uses the Telcor middleware solution QML.

Read More »

Roads cross in clonal hematopoiesis and stem cell studies

March 2016—At the annual meeting of the Association for Molecular Pathology in November 2015, one plenary session was called “Exciting Times for Translational Research in Molecular Hematology.” In accord with the title, Margaret Goodell, PhD, gave an exciting talk about how hematopoietic stem cells are regulated in mice. While Dr. Goodell’s basic research was impressive, what was most remarkable was how it meshed with and anticipated research in human hematopoietic malignancies from other laboratories.

Read More »

Newsbytes, 3/16

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

Read More »

Put It on the Board, 3/16

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

Read More »

PD-L1, other targeted therapies await more standardized IHC

February 2016—Immunohistochemistry is heading down a path toward more standardization, and that’s essential as it plays an increasing role in rapidly expanding immunotherapy, says David L. Rimm, MD, PhD, professor of pathology and of medicine (oncology) and director of translational pathology at Yale University School of Medicine. As a co-presenter of a webinar produced by CAP TODAY in collaboration with Horizon Diagnostics, titled “Immunohistochemistry Through the Lens of Companion Diagnostics” (http://j.mp/ihclens_webinar), he analyzes the core challenges of IHC’s adaptation to the needs of precision medicine: binary versus continuous IHC, measuring as opposed to counting or viewing by the pathologist, automation, and assay performance versus protein measurement.

Read More »

Bladder cancer preps for its star turn

February 2016—A streak of sibling rivalry emerges when experts ponder progress in the field of bladder cancer. Whether it’s new markers or therapies, funding or advocacy, advances have come slowly, and the disease has long labored in the shadow of others. “Urologic malignancies in general lag behind, compared to breast cancer and other tumor types, like colon and lung, where we’ve been envious for a while,” says George Netto, MD, professor of pathology, urology, and oncology and director of surgical pathology molecular diagnostics, Johns Hopkins University School of Medicine.

Read More »

Community hospitals keep time on tissue handling

February 2016—The great promise of genomics and actionable cancer biomarkers relies on cancer tissues being handled in the right way so they are suitable for study. Reducing cold ischemia time and the total time that biospecimens spend in formalin is key to the process, say guidelines from the CAP and the American Society of Clinical Oncology on HER2 and on estrogen receptor and progesterone receptor testing in breast cancer specimens.

Read More »

Non-melanocytic lesions—preventing pitfalls in diagnosis

February 2016—Musician Lauryn Hill has been quoted as saying, “Reality is easy. It’s deception that’s the hard work.” That viewpoint just might resonate with pathologists who sometimes have to diagnose deceiving-looking skin lesions. In a talk at CAP ’15, Deborah L. Cook, MD, professor of pathology and director of dermatopathology at the University of Vermont, shared several case examples that illustrate that investigative effort. All of them involve non-melanocytic malignancies known to mimic benign entities and the converse—“the proverbial wolf in sheep’s clothing” and “sheep in wolf’s clothing,” as she puts it.

Read More »

Clinical Pathology Abstracts, 2/16

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

Read More »

Anatomic Pathology Abstracts, 2/16

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

Read More »

Newsbytes, 2/16

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

Read More »

Q&A column, 2/16

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

Read More »

Put It on the Board, 1/16

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

Read More »

Rebooting IHC for companion diagnostics

January 2016—Immunotherapy has taken cancer treatment by storm. And given the number of proteins that are targets for immunotherapy and other targeted therapies, immunohistochemistry should theoretically be the ideal method for classifying patients as responders versus non-responders. But there are several reasons why IHC hasn’t reached this status within personalized medicine, says Clive R. Taylor, MD, DPhil, professor of pathology in the Keck School of Medicine of the University of Southern California.

Read More »

In next-gen sequencing, panel versus exome

January 2016—As next-generation sequencing takes its place in clinical laboratory medicine, a difference is developing between its use when there is a defined phenotype, as with hereditary oncology syndromes or hereditary cardiovascular disorders, and its use in diagnosing hereditary developmental disorders. In oncology, targeted panels remain the optimal mode of application.

Read More »

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

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

Read More »

Nanotechnology in the clinical laboratory

January 2016—The CAP has 30 official liaisons to various organizations who attend scientific meetings or designate others to do so. They report to the Standards Committee, which reports to the Council on Scientific Affairs. We periodically publish bits of what the CAP’s outbound liaisons hear and see in their liaison roles.

Read More »

For infection control, PCR and culture compared
Plus, an in-house PCR test for HSV in CSF

January 2016—There is a reason why rigorous studies are done to prove even the seemingly apparent benefits of advanced techniques. Sometimes comparisons turn up unexpected findings, as demonstrated by two selected infectious disease abstracts about real-time PCR presented at the Nov. 5–7, 2015 meeting of the Association for Molecular Pathology. Even so, both abstracts show the value of PCR testing.

Read More »

Cytopathology + More | Anal cytology: life-saving potential at low cost

January 2016—Anal cancer incidence is on the rise in North America with rates of both invasive and in situ squamous carcinomas of the anus increasing sharply over the past several decades. While women have the highest overall likelihood of developing anal carcinomas, certain male subpopulations (namely men who have sex with men and those who are HIV positive) are at a dramatically increased risk of developing squamous precursors and carcinomas of the anal canal.

Read More »

Molecular Pathology Selected Abstracts, 1/16

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

Read More »

Newsbytes, 1/16

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

Read More »

Anatomic Pathology Abstracts, 1/16

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

Read More »

Clinical Pathology Abstracts, 1/16

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

Read More »

Q&A column, 1/16

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

Read More »

Open house: CMS welcomes lab input in fee talks

October 2002—Laboratory specialty groups praised the Centers for Medicare and Medicaid Services for how it handled its recent meeting on payments for new clinical laboratory tests. CMS went so far as to say it would reconsider previous pricing decisions, a surprising and welcome change from its traditional “black box”approach.

Read More »

Quick on the draw—coagulation tube response

October 2002—As the sensitivity of coagulation testing has increased, the preanalytical phase has been getting more attention as a potential source of error. Variables that have long been known to affect the accuracy of activated partial thromboplastin times are the reagents and instruments used in testing and the delays between acquiring and processing a blood sample.

Read More »
CAP TODAY
X