ARTICLES

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?

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.

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.

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.

January 2015–Review the final pathology-related Medicare relative value units for 2015, as detailed in the Centers for Medicare and Medicaid Services final physician fee schedule, released Dec. 23, 2014.

December 2014—Here it was, the kind of massive postpartum hemorrhage case for which the team at Duke University Medical Center had spent months preparing. The multidisciplinary group had agreed on which laboratory tests would be done in such a case, determined which blood products would be delivered, and decided which members of the OB team would be sent racing to retrieve the potentially life-saving package.

December 2014—Two new analyzers and a new workcell automation solution are in this year’s product guide to hematology analyzers. Sysmex’s newest offering is its XN-1000 R Automated Hematology Analyzer, an entry-level XN system for laboratories that run fewer than 100 CBCs per day.

December 2014—Anemia is in the eye of the classifier. While that’s not as elegant as the “beauty-beholder” saying, it’s much more important. To be able to effectively treat and diagnose anemia, “You have to know what is causing the decrease in red cells,” said Sherrie Perkins, MD, PhD, speaking at an AACC workshop this year. There are plenty of definitions to choose from, said Dr. Perkins, of the University of Utah/ARUP Laboratories, Salt Lake City. At the most basic level, she noted, anemia is a pathologic condition marked by a reduced capacity of blood to transport and deliver adequate oxygen to tissues. In short, anemia is a manifestation of disease, not a disease itself.

December 2014—Elevated vancomycin minimum inhibitory concentrations do not increase the risk of death in patients with Staphylococcus aureus bacteremia, according to the findings of a comprehensive meta-analysis published in the Oct. 9 issue of JAMA. Despite widespread speculation about rising vancomycin resistance, or “MIC creep,” the authors find little evidence to challenge the current CLSI susceptibility breakpoint of ≤ 2 µg/mL for vancomycin.

December 2014—In addition to preparing for Ebola patients, many clinical laboratories and hospitals in recent months faced outbreaks of respiratory illness caused by enterovirus D68 among children. “EV-D68 infections may be associated with severe acute respiratory illness, viral pneumonia, and severe reactive airway disease,” says Susan Novak, PhD, D(ABMM), director of microbiology at Kaiser Permanente Regional Reference Laboratories in Southern California. Focal limb weakness has also been reported as possibly related to EV-D68, she adds.

December 2014—Securing financial support and setting up a quality management program are two of the biggest challenges to creating a successful biospecimen repository, says Nilsa C. Ramirez, MD, director of the Biopathology Center of the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio.

December 2014—A widespread concern in the collection of biospecimens is the degree of variation in the collection procedures. Standardization of biospecimen collection kits is an effective way to ensure greater consistency in biospecimen collection. These kits often contain all the materials necessary to properly collect, preserve, and ship biospecimens to the biorepository.

December 2014—The handling of molecular information bears a certain resemblance to Wall Street’s bundling of mortgages in recent years. You can slice ’em, dice ’em, and repackage them in all sorts of ways. In medicine, however, this is being done—one would hope—without the ensuing meltdown. The goal is to shape personalized medicine, using the results of next-generation sequencing and other technologies to evaluate genetic information ranging from single gene to whole exome or whole genome, with proteomics possibly not too far behind.

December 2014—Like sailing ships, laboratories hope for fair winds as they chart their business plans. But smooth sailing is never a sure bet; rough sea conditions are an ever-present possibility that can make ships hard to steer. Perhaps the tide is with the vessel but the winds are against it. That’s a situation that could aptly describe a health care system facing a growing patient population at the same time that hospital admissions and reimbursement are in decline.

December 2014—Clinical laboratories have made impressive headway in their Ebola preparedness, though their plans are shaping up in different ways. That’s due, in part, to varying opinions about how to manage a dangerous and unpredictable virus. “We are really learning as we go along with this,” says D. Jane Hata, PhD, D(ABMM), director of microbiology and serology at Mayo Clinic in Jacksonville, Fla. For years there has been talk of the possibility of an airplane passenger bringing Ebola into the U.S., she says. “But we are on the ground now and we’re all actively planning to deal with this.”

November 2014—It’s been said that “data” is the plural of “anecdote,” and debate has swirled around whether that is true. Something about data makes most of us feel that it is qualitatively different: more manipulable, more reliable, more helpful in drawing useful conclusions. But is there a new stage that might be considered the plural of data? These days, the health care industry is excited about a concept that promises to catapult the value of laboratory information into a new era. It’s the Enterprise Data Warehouse.

November 2014—So, you have a great idea that will improve laboratory workflow and reduce errors? Chances are the change will depend on automation of some sort, and will involve the LIS. But upgrades to laboratory information systems may not come fast enough, and the middleware may not be available to accomplish what you need. Then the question becomes how to customize the LIS to achieve your aims.

November 2014—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. Here, this month, is case No. 6. (See the February, August, and September 2013 and the May and June 2014 issues for the first five.) AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, treatment, and more. Case report No. 6 comes from UT-MD Anderson Cancer Center in Houston.

November 2014—When Birgit H. Funke, PhD, gave a talk earlier this year on incorporating bioinformatic tools and pipelines into medical NGS, at Molecular Medicine Tri-Con 2014, one of her slides showed the main bioinformatics activities needed to support sequencing. Among them were designing and building pipelines to manage genetic data, writing scripts for data analysis pipelines, and building custom applications.

November 2014—Molecular testing, on a steep growth curve in anatomic pathology, is increasingly providing decisive guidance for treatment of cancer patients. But while guidelines on clinical relevance and performance of common molecular tests are available and widely used in theory, to date there has been limited information on how well requests for molecular testing in AP laboratories are adhering to the guidelines.

November 2014—The Centers for Medicare and Medicaid Services on Oct. 31 published its 2015 Medicare physician fee schedule to set payment rates and policy for the next year, including the relative value units for existing and new Current Procedural Terminology codes. Several of the CAP’s recommendations and proposals were accepted for inclusion, such as three new quality measures designed for pathologists and eliminating G-codes to pay for immunohistochemistry services.

November 2014—Pathology resident Beth Ellen Frost, DO, has at times taken an uncommon step to put family members at ease when they are asked to consent, or have consented, to an autopsy for a loved one: She’s providing her cell phone number. Simple but purposeful, and it’s one part of a new initiative to improve the University of Kentucky HealthCare system’s autopsy process, which has other pathology staff handing out numbers too.

October 2014—Last month the molecular and genomic pathology laboratory of the University of Pittsburgh Medical Center posted on the AMP listserv its requirements for a bioinformatics scientist to support next-generation sequencing for clinical testing. The requirements consisted of, but were not limited to:

October 2014—From a focus on donor screening to inroads with inventory and tweaks to transfusion functionality, marketers of blood bank information systems and ancillary solutions continue to make their products faster, safer, smarter, greener. Here’s what CAP TODAY heard about what’s new and soon to come.

October 2014—Like many cytopathology trainees, Charanjeet Singh, MD, who recently completed a cytopathology fellowship at MD Anderson Cancer Center in Houston, found it challenging at times to find classic examples of entities to learn from and to study for exams. Most texts he consulted contained just one or two images of a particular diagnosis. And the material in training programs from all specialties varies. Even though there is a large volume of cytology cases at MD Anderson, for example, it wasn’t enough to learn gynecologic cytology, which is why he pursued an elective rotation at Houston Methodist Hospital.

October 2014—The debut of the CMS’ new quality control option, IQCP, has sharpened the focus on QC in the laboratory and raised hopes that risk management concepts can make QC more robust. But one of the most highly regarded quality control experts in the U.S. voices skepticism about the impact of IQCP—and indeed, about U.S. quality control standards in general.

October 2014—When it comes to the blood supply, the tradeoffs between safety and availability are a tightrope that blood centers walk with extreme care. For several years now, TRALI (transfusion-related acute lung injury) has topped the list of causes of transfusion-related mortality in the U.S. Defined as acute lung injury that occurs during or within six hours of transfusion of a blood product, TRALI is fatal to six to 10 percent of the patients it strikes.

October 2014—Along with everything else the genomics revolution has wrought, there’s this: Molecular testing is threatening to turn medicine into an ongoing episode of “Hoarders.” So much information and so many possible uses for it—including, in some cases, none at all. The expansion of molecular testing is also upending the role of the traditional tumor board.

October 2014—Stanley J. Robboy, MD, was presented Sept. 7 with the Pathologist of the Year award during an evening event at the CAP ’14 annual meeting in Chicago. At the same event, at the Hyatt Regency Chicago, Seema Sethi, MD, was honored as Resident of the Year, and Samir Sami Amr, MD, received the Pathology Advancement award. The CAP Foundation Gene and Jean Herbek Humanitarian award went to Barbarajean Magnani, PhD, MD, who was given a second award: the Distinguished Patient Care award.

October 2014—Whether exotic influenza viruses will surface this winter remains to be seen, but one thing is clear: The coming season will pack a punch in terms of promising diagnostics and forecasting models.

September 2014—Newly reported survey data that show widely varying international practices on managing critical values may demonstrate the need for a new guideline—already in development—to help laboratories formulate evidence-based policies. The new data from European labs were presented during a session at the American Association for Clinical Chemistry’s Annual Meeting and Clinical Expo in Chicago (“Critical Result Management Practices: Global Perspectives and Recommendations for Best Practices”). The session also provided a preview of a forthcoming draft guideline from the Clinical and Laboratory Standards Institute that represents the organization’s first formal attempt to advise laboratories around the world on critical values reporting.

September 2014—With nearly two dozen manufacturers of immunoassay analyzers represented in CAP TODAY’s product guide this month, the market is rich with options. At least three of those companies have enhanced, or are about to enhance, their existing analyzers with new functions or assays.

September 2014—It would be a nightmare for any laboratory professional: a misdiagnosed and mistreated patient owing to an aberrant test result. Julia C. Drees, PhD, a scientific director for chemistry at TPMG Regional Reference Laboratory, Kaiser Permanente Northern California, found herself facing that situation two years ago. She and colleague Judy Stone, PhD, then a Kaiser scientific director who is now at UCSD, discovered that faulty TSH results from their laboratory had led to multiple patients being misdiagnosed, and some even treated inappropriately.

September 2014—Medical practice is no stranger to good things coming from bad, but lest anyone be in doubt, Children’s Hospital and Medical Center in Omaha provides a striking example. The bad, in this case, was an exorbitant bill for genetic testing delivered several years ago to the parents of a sick child. The family had no idea such an expensive test had been ordered or that their insurance company would not pay for it.

September 2014—With the FDA having approved use of the Roche Cobas assay for human papillomavirus as a primary standalone screen for cervical cancer in women 25 and older, expert panels are faced with the challenge of working the algorithm into current best practice recommendations for cervical cancer screening.

September 2014—Industrial risk management. It may not seem all that sexy as a concept, but in the field of laboratory quality control, risk management has become about as buzzworthy as is possible. One of the key reasons: The Centers for Medicare and Medicaid Services has embraced risk management as the foundation of a new option for meeting CLIA quality control standards called IQCP, or Individualized Quality Control Plan.

September 2014—At the 30th Annual Clinical Virology Symposium this spring, Gregory Storch, MD, related a typical case of a febrile child seen in the emergency department. Dr. Storch, a professor of pediatrics at Washington University School of Medicine, described a 20-month-old boy with a fever of 40°C, rash, cough, and nasal congestion but no gastrointestinal symptoms. White blood cell count was 7,800/µL. Blood culture was negative and a chest x-ray showed mild peribranchial thickening. Diagnosis, Dr. Storch says, was “viral syndrome.” The patient got a dose of ceftriaxone, which was “reasonable,” in Dr. Storch’s view, in light of the patient’s fever and the presence of bands on the peripheral blood smear.

August 2014—This year’s guide to chemistry analyzers for low-volume laboratories consists of information supplied by 17 companies on 33 analyzers, three of which are new to this guide. Vital Diagnostics, an ElitechGroup Company, launched the Eon 300 Clinical Chemistry system. The system is sold exclusively by McKesson Medical Surgical to small to midsize physician offices and satellite and hospital laboratories.

August 2014—Payment rates declining. Bad debt rising. Test orders falling. Diagnostic equipment manufacturers checking in on test-volume commitments. A wrenching transition from fee-for-service care to population-based medicine. These are a few of the trends that laboratories across the country are seeing and that keep lab directors up at night, heavy lidded, checking their email, illuminated by the glow of their smartphones.

August 2014—A slow leak in a tire may not be all that interesting— until one is cruising down the highway at 75 m.p.h. Suddenly, that same leak becomes much more compelling. Joseph Misdraji, MD, recalls a conversation he had at a meeting about pseudomyxoma peritonei that skirted a similar curve in the road. Approached by a pathologist who expressed a desire to collaborate with him, Dr. Misdraji suggested a study he was working on, looking at the significance of proximal margin involvement in low-grade appendiceal mucinous neoplasms, or LAMN.

August 2014—A familiar optical illusion uses a drawing of a vase that makes your eyes play tricks. First you see the vase, then two faces gazing at each other, then again, the vase…two faces…ad infinitum. It’s a concept that comes to mind when thinking about “tracking” in the anatomic pathology laboratory. Does it refer to a physical track—a conveyor belt to automatically transport and sort specimens—or to a system for “tracking”—that is, electronically keeping tabs on specimens?

August 2014—Are children equivalent to miniature adults? Common sense and years of research on age-related differences in microbiota, immune system development, and infectious disease susceptibility point to a resounding no. But in clinical microbiology practice, if not in theory, pediatric patients are too often worked up as miniature adults, says Jennifer Dien Bard, PhD, D(ABMM), FCCM, director of the clinical microbiology laboratory and acting director of the clinical virology laboratory at Children’s Hospital Los Angeles, and an assistant professor of clinical pathology at the University of Southern California’s Keck School of Medicine.

August 2014—How the Medicare program reimburses pathologists for prostate biopsy specimen services could change in 2015 under proposed rules for physician payment from the Centers for Medicare and Medicaid Services. The CMS detailed its proposed plans for prostate biopsy reimbursement, in addition to other payment policy changes concerning pathologists, in the proposed 2015 Medicare physician fee schedule released July 3. The proposal includes adding three new pathology measures, sponsored by the CAP, to the Medicare Physician Quality Reporting System and the expansion of CMS’ value-based modifier program. After a 60-day comment period, the CMS will finalize the 2015 fee schedule later this year.

August 2014—Change takes time. Ask anyone who’s ever joined a gym, coached an underperforming sports team, or felt themselves growing older—cell by graying, wrinkling cell—in the change-of-address line at the DMV. Or just ask Donald Karcher, MD. Since 2008, when the Joint Commission began mandating that health care organizations rigorously evaluate physician performance when granting or renewing practice privileges, Dr. Karcher has watched laboratories gradually move from noncompliance to curiosity to comprehension and finally to compliance.

August 2014—The humble Pap test is perhaps one of the most lauded and disdained laboratory tests, lauded because it is the lab test with the best track record of preventing cancer and disdained because the test is labor-intensive, the results are operator dependent, and the regulations are burdensome. Recently the Pap test has come under fire, threatened to be replaced with HPV tests and maligned by patients and physicians for its sometimes unexpected high cost.

August 2014—It has been almost 10 years since gynecologic cytology proficiency testing, or Pap PT, was implemented in the United States. The CAP is one of three organizations with a Pap proficiency testing program. Pap PT is unique in medicine. In no other situation are licensed physicians or certified technologists required to pass a federally mandated, annual proficiency test before they can practice a skill for which they were trained. Individuals who do not pass Pap PT after two tests cannot practice the interpretation of gynecologic cytopathology until they pass the test.

August 2014—The Food and Drug Administration Microbiology Devices Panel of the Medical Devices Advisory Committee held a hearing March 12 on a proposal by Roche Molecular Systems for a new application of human papillomavirus first-line primary cervical cancer screening for women age 25 and older. The 13-member panel unanimously approved the test as safe and effective with benefits to women’s health. The FDA formally approved the additional testing indication on April 24.

August 2014—A race for prevention may lack the drama of a race for the cure. But to fight methicillin-resistant Staphylococcus aureus and other multidrug- resistant organisms, hospitals really have no choice. A disease with a higher number of annual U.S. deaths than for salmonella, tuberculosis, influenza, and HIV put together, MRSA can only be tamed with prevention.

August 2014—In the days after my “Perspective” piece on the thousand-dollar Pap smear was published,1 I was profoundly moved by the number of physicians from diverse specialties and practice settings who reached out to tell me how important they believe issues of cost and cost transparency are to our ability to practice in the best interest of our patients. Barbara Crothers, DO, of the CAP Cytopathology Committee, was among those who reached out. I learned from Dr. Crothers and her colleagues that pathologists share the sense of frustration and loss of control that I often have as a primary care provider confronted by opaque ordering systems and skyrocketing costs for a simple, potentially life-saving test.

July 2014—When it comes to molecular testing for acute myeloid leukemia, the approach seems more Montessori than military school. There are some basic steps physicians should take, to be sure. Cytogenetics still shepherds patients into three prognostic groups: favorable, intermediate, and unfavorable. And several gene mutations—NPM1, CEBPA, FLT3, and KIT—alone or in combination, and with various cytogenetic associations, provide additional prognostic and therapeutic guidance.

July 2014—Before the Affordable Care Act was passed, and before the notion of an ACO became a Medicare reality, Richard J. Cote, MD, was among those in medicine who saw the writing on the wall regarding health care payment. Dr. Cote recalls his thinking as he joined the University of Miami Miller School of Medicine in 2009 to become chair of its Department of Pathology.

July 2014—A glance at most hospital laboratory spreadsheet makes it clear: Where laboratories could reduce high-cost reference testing for inpatients and unreimbursed send-out testing for outpatients, the savings would be striking. But voluntary education programs geared to improving test ordering practices are known to have their limits. Could a mild form of, well, coercion be helpful?

July 2014—Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations.

July 2014—Missouri is no country for old men. Clinical, laboratory, and epidemiologic investigations conducted during the past five years have identified a new virus that can cause considerable illness and perhaps even death. All eight patients definitively proven to be ill with this virus have been over age 50; seven lived in Missouri.

July 2014—When Rosemary Frederick learned last year that her employer, North Shore-LIJ Health System of New York state, would be switching from the Roche Accu-Chek Inform I point-of-care glucose meter to the Inform II due to a maltose interference issue, she knew she and her colleagues were facing a heck of a lot of work.

July 2014—Hospitals are under fire to cut costs, and more often than not that means layoffs, forgoing new equipment, and watching from the sidelines as the medical literature touts advances that could help patients now—if only institutions could afford to implement them.

July 2014—G-G-G-E♭. Also known as da-da-da-DUM. Also known as the opening to Beethoven’s Fifth Symphony. It’s a simple motif, heard repeatedly in the piece (not to mention across the centuries), yet no less thrilling for that fact. Maria M. Picken, MD, PhD, finds herself repeating an equally straightforward motif when she speaks about amyloidosis, and it, too, is worth hearing again: The disease is not being diagnosed early enough, and sometimes not at all. That theme has been a steady refrain of hers over the years, and it runs throughout a recent interview with CAP TODAY, so much so that she worries readers will respond with, Oh no, here she goes again.

June 2014—When Mark Stoler, MD, stood up to speak at the 30th annual Clinical Virology Symposium on April 29, his topic was timely. Dr. Stoler was presenting three-year followup data from the ATHENA trial, in which a primary human papillomavirus screening algorithm based on the Roche Cobas HPV assay was compared with traditional cytology and a hybrid cotesting algorithm for their ability to prevent cervical cancer.

June 2014—Cleared in April by the FDA is Nova’s newest—the Stat Profile Prime, which features Zero maintenance cartridges and MicroSensor technology. The Zero maintenance cartridge technology consists of individual cartridges for biosensors, calibrators, and liquid QC. The design optimizes the life of each cartridge, improves analyzer uptime, and eliminates the waste, downtime, and higher costs associated with older systems, says Rick Rollins, Nova marketing specialist. Stat Profile Prime analyzers deliver a 10-test profile—pH, PCO2 , PO2 , Na, K, iCa, Cl, Hct, glucose, and lactate—in 60 seconds.

June 2014—If they made disaster movies about the laboratory industry, you could cue the voice talent right now, because all the plot elements seem ready at hand. In a world where an economy haltingly recovers from the blows of recession, a series of double-digit reimbursement cuts for laboratory services looms. New financial accounting standards lurk in the background, threatening to roil traditional equipment rental arrangements. A mammoth national health insurance program rolls out, generating fears of one set of dictates to rule them all.

June 2014—Despite an explosion of research into cancer biomarkers and professional guidelines that urge testing for certain genetic mutations that help detect disease, anticipate its course, or predict response to treatment, many cancer centers are out of sync with oncology testing recommendations. Payment policies, regulatory oversight, clinician preferences, and varying access to testing technology are among the factors that contribute to discrepancies in cancer care.

June 2014—The CAP’s leaders say they will keep pushing for favorable pathology payment policies as federal regulators implement new legislation that could lead to steep cuts in Medicare rates. Six weeks before the May 5–7 CAP Policy Meeting in Washington, DC, Congress enacted the Protecting Access to Medicare Act of 2014. The bill, signed into law April 1, stopped cuts to physician services under the flawed Medicare sustainable growth rate formula used to calculate Medicare pay.

June 2014—Scientific wonders always abound at the Advances in Genome Biology and Technology conference, and this year’s meeting in February was no exception. Attendees had their first opportunity at a scientific meeting to learn about the newly announced Illumina HiSeq X Ten, a combination of 10 HiSeq X systems, which, Illumina says, can sequence 16 whole human genomes per three-day run at a read depth of 30× and a cost of $1,000 per genome. At the other end of the scale, attendees saw the unveiling of Oxford Nanopore’s MinION, a sequencer the size of a pack of chewing gum.

June 2014—Post-transplantation lymphoprolif-erative disorders (PTLD) encompass a spectrum of neoplasms, ranging from benign hyperplasia to non-Hodgkin lymphoma and Hodgkin lymphoma. Epstein-Barr virus is postulated to play a key role in the pathogenesis of PTLD in patients who were previously EBV negative. This is a case report of a 52-year-old female, status post unrelated bone marrow transplant for myelofibrosis, who developed primary central nervous system diffuse large B-cell lymphoma, post-transplantation.

June 2014—In research and development of diagnostics based on the small, non-coding RNAs known as microRNA, the potential clinical applications in cancer were the first to be explored and have hogged the spotlight. But the more light that is shed on micro­RNAs’ mysteries, the more promise microRNA shows as a diagnostic and therapeutic tool in an array of diseases beyond cancer.

May 2014—Recently I received the 2014 CAP PAPM-A (gynecologic pathology) slide set and was surprised to see case No. 5: a Pap test from an 82-year-old woman with a clinical history of “routine exam.” The cervical cancer screening recommendations from the U.S. Preventive Services Task Force recommend against screening women over the age of 65 who have had adequate prior screening and are not at high risk for cervical cancer, while the American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology guidelines recommend no screening for women over age 65 with evidence of adequate negative prior screening and no history of CIN2+ within the past 20 years.

May 2014—A tipping point implies a point of no return, a monumental change in the status quo, a transformation that leads to a new paradigm. Malcolm Gladwell, in The Tipping Point: How Little Things Can Make a Big Difference, popularized the term and defined it as “the moment of critical mass, the threshold, the boiling point.” Tipping points bring both positive and negative consequences; they are a time of change and opportunity. Such is the position that cytopathology finds itself in today.

May 2014—Gerald Hoeltge, MD, chair of the CAP Checklists Committee, is pretty sure he knows exactly the way many laboratories will react to a particular change in the latest edition of the Laboratory Accreditation Program checklists, which launch this month.

May 2014—If one were to map out a “family tree” of tumors, breast and gastric cancers might end up looking like second cousins. One is common, the other is not, but it’s rapidly becoming known that they share a kinship of sorts with HER2 testing and the targeted therapy trastuzumab.

May 2014—Modern health care is more advanced than ever, but institutions continue to battle one problem that refuses to go away: hospital-acquired infections. They should be preventable, yet a recent CDC report estimates that one in 25 U.S. patients acquired at least one infection during a hospital stay in 2011. The most pervasive nosocomial pathogens, by far, are Clostridium difficile and Staphylococcus aureus.

May 2014—From federal requirements to voluntary standards to back-office activities and business tools, vendors of billing/AR/RCM systems share how they are helping their clients. Beginning on page 16 is CAP TODAY’s 2014 guide to lab billing/accounts receivable/revenue cycle management systems.

May 2014—“There are known knowns; there are things that we know that we know,” then-defense secretary Donald Rumsfeld famously said in response to a question at a 2002 news briefing. “We also know there are known unknowns. . . .” he added. “But there are also unknown unknowns, the ones we don’t know we don’t know.”

May 2014—Some diseases have clear origins and unfold in predictable ways, but cancer isn’t one of them. Despite legions of studies over the decades, cancer tumorigenesis and its deadly sequel, metastasis, essentially remain a riddle, wrapped in a mystery, inside an enigma, as Winston Churchill once described Russia.

May 2014—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. Here, this month, is the fourth such case. (See the February, August, and September 2013 issues for the first three.) AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, treatment, and more. Case report No. 4 comes from the Department of Pathology and Laboratory Medicine, Hospital of the University of Pennsylvania.

May 2014—Rapid on-site evaluation, or ROSE, is a service that pathologists and cytotechnologists commonly perform to check the cellular content and adequacy of fine-needle aspiration smears and biopsy touch imprints. ROSE can inform the operator of the need to obtain additional samples and, in this cost-conscious age, make it possible to avoid having to repeat the procedure. ROSE allows for preliminary diagnosis so that additional material can be requested for ancillary studies such as flow cytometry, microbiology cultures, or molecular studies.

April 2014—It can be hard to remember a time when GPS was not available in cars, the Web didn’t exist, and only eight diagnostic tests were classified as waived and able to be performed at the point of care. But after CLIA’s enactment in 1988, those were some basic realities of location and speed.

April 2014—The Department of Laboratory Medicine and Pathology is one of the largest departments at Mayo Clinic, with approximately 3,250 employees who work in 61 specialty labs at seven locations across Rochester, Minn. Throughout this large department, about 300 employees are designated to order supplies for their work units, which consist of laboratory and support staff. Before 2008, there was no standard process for ordering office supplies, which led to inefficient practices and escalating costs over time.

April 2014—As reimbursement models change, achieving better test utilization will become a survival strategy. And in the hard work to improve test use, the computerized physician order-entry system appears to be the work tool with the winning record. Inpatient laboratory tests at Massachusetts General Hospital fell by 21 percent between 2002 and 2007, despite a seven percent increase in the number of discharges. Per discharge, inpatient tests dropped by 26 percent (Kim JY, et al. Am J Clin Pathol. 2011;135:108–118). Kent B. Lewandrowski, MD, associate chief of pathology and director of laboratory and molecular medicine at MGH and professor of pathology at Harvard Medical School, calls the number of inpatient tests per discharge “a global benchmark,” saying, “It rolls up all of our individual utilization initiatives.”

April 2014—Talk to a few microbiology laboratories about why they feel the need to automate and you hear common themes: people, space, quality, and, most of all, time to detection. Microbiology may be late to join the bandwagon, but whether laboratories are making partial or full-scale moves to automate, they are dramatically making up for lost time, in all senses of the phrase. That’s because turnaround time savings are no longer measured in minutes. “Our goal is to be able to give some of these answers out in one to four hours rather than 24 hours, or much longer for some culture-based methods,” says Randall T. Hayden, MD, director of clinical and molecular microbiology at St. Jude Children’s Hospital in Memphis.

April 2014—Despite warfarin’s continued presence near the top of the FDA’s list of adverse drug events and the availability of competing agents, the drug continues to be a mainstay of anticoagulant therapy, particularly among general practitioners. Its narrow therapeutic window and intra- and interpatient variability require regular measurement of the international normalized ratio. This, along with the large genetic component to warfarin response, principally contributed by variants in the genes VKORC1 (–1639G ➞ A) and CYP2C9 (*2 and *3), led many to hypothesize that pharmacogenetics could improve warfarin safety.

April 2014—In what may be a first for the burgeoning field of next-generation sequencing, this powerful new technology was used to identify the cause of encephalitis in a teenage boy who had been critically ill in the intensive care unit for several weeks. Diagnosis suggested a specific treatment. Within two weeks of initiating therapy, the boy had recovered and was discharged. It is becoming common practice to use NGS to detect mutations that can help select drug therapy in cancer cases and to find genetic variations responsible for inherited diseases. However, NGS has not previously been considered a useful tool in critical care situations, where a short turnaround time is crucial.

April 2014—Most pathologists are trained to think of hypotensive transfusion reactions as rare events, and for the most part they are. But one pathologist’s experience suggests these reactions may be underreported, and perhaps on the rise. Greater recognition of these events could provide valuable information and help improve patient outcomes. “People often report these reactions as possibly related to transfusions, but the challenge to the pathologist is that the transfusion reaction workups are negative, for the most part. So they’re in a quandary as to whether the drop in blood pressure was because of the transfusion or other causes,” says Richard M. Scanlan, MD, clinical professor, vice chair of laboratory medicine, and director of the transfusion medicine service at Oregon Health and Science University (OHSU).

April 2014—It’s not a race, but you gotta keep pace or risk losing face (and customers and revenue). While this rhyme isn’t an axiom, for vendors of laboratory-provider linking software, it might as well be. “It seems like a new health care initiative, best practice, or regulation is announced every year,” says Tim Kowalski, president and CEO of Halfpenny Technologies. “That makes it crucial to choose laboratory vendor partnerships and solutions that are designed to withstand this ever-changing industry.”

March 2014—Tracks, modules, rules, consolidations, connections. Marketers of lab automation systems and workcells are busy turning out and fine-tuning what labs of all sizes need in the face of staff shortages, belt-tightening, growing workloads, and the need to implement a new set of best practices as payment shifts from volume-based to value-based. “Automation systems that provide answers to these challenges will help fulfill the original promise of laboratory automation and become the new standards of automation innovation,” says Jeremy Kiger, marketing manager for lab automation and IT, Roche Diagnostics.

March 2014—Like Gypsy Rose Lee, tests and their true nature reveal themselves bit by bit. For immunohistochemistry, this unhurried disclosure has meant evolving ideas of whether these tests must indeed be validated and, if so, then how, exactly. The discussion recently culminated in a new CAP guideline for laboratories.

March 2014—Maryland may be one of the smallest states in the nation, but its new effort to reduce spending on hospital services could have a big impact on patient care and health care costs. In January, after a three-year, 10-site pilot program, most of the state’s hospitals decided to move to a system under which “the hospitals are given a fixed budget and asked to manage the care of the patients they serve within that budget,” says Maryland Hospital Association president and CEO Carmela Coyle.

March 2014—Not many components of human cell biology have been discovered and immediately dubbed “junk.” But micro-RNAs, small noncoding RNA molecules first identified in 1993, fall into that category. Like Hans Christian Andersen’s Ugly Duckling, microRNAs began their life after discovery with people scoffing at them. People even laughed at researchers who thought microRNAs held promise in diagnosing cancer.

March 2014—A wide-ranging set of recommended health information technology safety practices recently issued by the Department of Health and Human Services is likely to accentuate the essential role that pathologists and laboratory leaders play in minimizing the adverse consequences of health IT.

March 2014—Boosters of so-called virtual autopsy say it has the potential to revolutionize the practice of forensic pathology and could help increase the share of U.S. deaths subject to medical autopsy. The technique involves the use of computed tomography, magnetic resonance imaging, and three-dimensional surface scanning technology to help resolve tricky forensic questions such as whether a woman was killed with a hammer or a bicycle wrench.

March 2014—Traditional urinalysis is messy. It’s tedious. It’s prone to variability. It’s nicknamed the “ugly stepchild” of the laboratory. Many are quick to note that it’s just a screening tool—with an emphasis on “just.” But in recent years, urinalysis has been quietly tiptoeing into a new era.

March 2014—If you had a colleague who was brilliant, experienced, and insightful, but who for some reason didn’t volunteer helpful information, you might agree with the assessment of Michael Laposata, MD, PhD: “If you only wait for people to ask you a question, that’s crazy.”

February 2014—All primary and subspecialty certificates that the American Board of Pathology issues are now time limited, and diplomates must successfully participate in the ABP’s Maintenance of Certification, or MOC, program to maintain certification. Part three of the four-part MOC program is the evaluation of cognitive expertise, which consists of a secure examination that assesses a diplomate’s pathology-specific knowledge, judgment, and skills.

February 2014—When it comes to breast cancer, medical oncologists have two “wish lists” for their pathologist colleagues. Here’s the short list of test results they need when they sit down with a patient, courtesy of Melody Cobleigh, MD. “ER, PR, HER2,” says Dr. Cobleigh, professor of medicine and the Brian Piccolo Chair for Cancer Research, Rush University Medical Center, Chicago. It’s a direct, unassailable answer. But so, too, is saying that the assassination of the Archduke Ferdinand caused World War I.

February 2014—If it were a boxing match, the debate over whether hemoglobin should be used to diagnose diabetes would place the odds-on favorite in the “Yes” corner. In the “No” corner would be the underdog. At least based on the mainstream consensus since 2010, HbA1c for diagnosis is well established as an alternative to measuring glucose.

February 2014—Utility companies can generate electricity in many ways—fossil fuel, nuclear reaction, solar panel, wind turbine. Which power source is preferable depends on the circumstances and the work that needs to be done. Generating optimal laboratory utilization is much the same. Providing an efficient and effective combination of tests for diagnosing hematologic neoplasms requires a different approach from achieving appropriate repeat ordering of chemistry tests in ICU patients. Delivering only the necessary blood components to cardiovascular surgery patients may take different tactics from curbing orders of expensive molecular genetic send-out tests.

February 2014—Recalling a reagent is about more than just removing a product from laboratory shelves. It’s about retracting test results and thus affecting diagnoses and treatment plans. It’s about questioning patient outcomes and revisiting past decisions. “So much of what laboratories do is central to making a diagnosis and determining treatment,” says John Harbour, MD, regional medical director of HealthPartners Laboratories, medical director of the Bon Secours St. Mary’s Hospital Laboratory, and president of Monument Pathologists Inc., Richmond, Va.

February 2014—For “quants”—people who love all things numeric or algorithmic—information technology is its own reason for being. But for those with responsibility for clinical outcomes and the bottom line in the clinical laboratory, IT is much, much more. Innovative uses of IT are providing myriad new solutions with measurable paybacks in quality improvement and cost reduction.

February 2014—Pathologists and laboratories have found new administrative challenges following deep payment cuts and policy changes in the 2014 Medicare physician fee schedule. By the time the fee schedule was finalized Nov. 27, 2013, pathologists were left with little time to sort through the impact of the changes before they became effective Jan. 1.

February 2014—What would you give for a little more time? Take a vital task that you do every day, every week, or every month, and do it about three times faster—with no effect on the quality of the outcome. No, this is not another comfort-food recipe from Rachael Ray’s best-selling series of 30-Minute Meals cookbooks.

February 2014—The Cytopathology Education and Technology Consortium in 2009 issued a statement on human papillomavirus DNA test utilization that was published in multiple journals. This statement was a concise summary of the clinical indications for high-risk or oncogenic HPV testing based on guidelines of the American Society for Colposcopy and Cervical Pathology and the American Cancer Society published from 2002 through 2007. These organizations have since published newer consensus guidelines addressing HPV testing, and the previous summary no longer reflects current screening and management guidelines.

February 2014—Call it the “Huh?” heard ’round the world: Just last month, Google spent $3.2 billion to acquire Nest Labs, a manufacturer of thermostats and smoke and carbon monoxide detectors. As Brandon Willis, director of technology at Pathagility, puts it, “Who knew Google would want a company that makes home thermostats?”

January 2014—A school-based quadrivalent human papillomavirus vaccine program was introduced in Australia in April 2007 for 12- to 13-year-old girls. This program was also extended to 14- to 17-year-old girls in schools and to 18- to 26-year-old women in the community. The vaccination program has been highly successful, with uptake rates of 86 percent, 82 percent, and 75 percent for doses one, two, and three, respectively. Australia also has an established National Cervical Screening Program. Screening is recommended at age 18, or two years after the onset of sexual activity.

January 2014—With the new year come fresh offerings from coagulation analyzer manufacturers, of which at least two have launched entirely new testing systems. Instrumentation Laboratory’s ACL AcuStar hemostasis system has been “met with great enthusiasm for its speed, accuracy, and comprehensive line of high performance chemiluminescent assays,” says Venita C. Shirley, director of marketing for commercial operations in North America.

January 2014—Meaningful use standards are fostering increasing patient access to medical records, including pathology reports. Yet pathology reports can be challenging even for clinicians, much less for patients, to understand. Nonetheless, it is typically left to the treating non-pathologist clinician to explain the findings to the patient, even when the clinician lacks detailed knowledge of pathologic features.

January 2014—A child born recently at Broward Health Medical Center was definitively diagnosed, without testing, as having a significant genetic abnormality. A medical resident eager to put his education into practice ordered genetic testing for the newborn, two normal siblings, and the child’s parents.

January 2014—A grassroots effort that mobilized pathologists around the country, and subsequent pressure from pathologists’ congressional representatives, beat back plans to limit non-hospital Medicare payments. But other pay changes instituted by the Centers for Medicare and Medicaid Services have created significant concerns for physicians and laboratories.

January 2014—Some studies indicate that nearly all cervical cancers are high-risk human papillomavirus (hrHPV)-related. Recent studies suggested hrHPV testing had a very high sensitivity; therefore, the American Society for Colposcopy and Cervical Pathology recommended Pap cytology and hrHPV co-testing as the preferred screening method in women 30 or older.

January 2014—When it comes to sexually transmitted infections, most clinicians and laboratories are well versed in diagnosing those caused by chlamydia, gonorrhea, HIV, and syphilis. But a host of lesser-known STIs often go undiagnosed, despite their surprising prevalence. Many of these STIs receive little publicity because they’re not considered reportable by the Centers for Disease Control and Prevention and the Council of State and Territorial Epidemiologists—a requirement that depends on a variety of factors, including whether an intervention is available and a public health response is indicated, and whether the disease or condition represents a threat to public health.

January 2014—Fewer children with respiratory disease symptoms hospitalized from the ED without a diagnosis, less antibiotic use, and a favorable ratio of reimbursement to expense. That’s what the laboratory at Children’s Healthcare of Atlanta is seeing, said Beverly B. Rogers, MD, chief of pathology, in a Nov. 5 webinar, “Focus on FilmArray: One New Technology Applied to Classic Clinical Problems.” Presented by CAP TODAY and made possible by an educational grant from BioFire Diagnostics, the webinar centered on the multiplex PCR system from BioFire that tests for viruses, bacteria, yeast, and antimicrobial resistance genes.

January 2014—Sleek specimen processing instruments, often with sophisticated robotics, are features of many larger microbiology laboratories, despite the longstanding belief that microbiology is too complex to automate. But total laboratory automation (TLA) has not yet gained a foothold in the U.S., even though there are several installations in microbiology laboratories in Europe. Could 2014 be the year that total microbiology laboratory automation comes into its own?

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

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

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

November 2013—When Richard J. Zarbo, MD, reflects on the strategy that helped his Detroit-based Henry Ford Health System achieve CAP accreditation to the ISO 15189 standard this summer, he likes to quote the system’s famously methodical founder: “Nothing is particularly hard if you divide it into small jobs.”

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

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

November 2013—When it comes to home improvement projects, we all have our own comfort level. Some of us order a load of lumber and build a new addition to our home; others limit themselves to assembling a bookcase from Ikea. And there are those who leave everything to professionals.

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

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

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

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

October 2013—Culturing organisms is not always easy. Some microbes are fastidious. Others are below the limits of detection. And still others are just difficult to culture, for no discernible reason.

October 2013—This is my first column, and it’s only good manners to introduce myself.

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

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

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

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

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

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

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

September 2013—If Mark Brecher, MD, were compiling a greatest hits list of medical successes of the 20th century, there’s one advance he’d be sure to include: the introduction of Rh immune globulin in the late 1960s to prevent the Rh sensitization of Rh-negative mothers who deliver an Rh-positive baby.

September 2013—For good or bad, Matthew Hiznay seems to be an odds beater. First, a minority of lung cancer patients have never smoked. He’s one of them, having been diagnosed with late-stage non-small-cell lung cancer in August 2011. Obviously, that’s the bad.

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

September 2013—With the 2013 edition of the Laboratory Accreditation Program checklist, the College moves to a new level in its effort to ensure the highest-quality practices in clinical laboratories’ use of next-generation DNA sequencing.

September 2013—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. Here, this month, is the third such case. (See the February 2013 issue for the first, on multilocus sequencing for rapid identification of molds, and last month’s issue for the second, on the importance of screening for Lynch syndrome in patients with endometrial cancer.) 

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

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

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

September 2013—From future innovations to tighter regulations, seven users and marketers of blood bank software shared their perspectives on the blood bank systems marketplace with CAP TODAY. Here and on the following pages is what they told us. Beginning on page 20 is the 2013 guide to blood bank information systems.

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

August 2013—Robert L. Michel doesn’t claim to have all the answers to all the problems laboratory medicine now faces. But as editor-in-chief of The Dark Report, the industry intelligence publication, he knows what those problems are chapter and verse. He also sees where future problems lie.

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

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

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

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

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

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

Busy as they were preparing for the annual American Association for Clinical Chemistry meeting last month, several vendors of in vitro blood gas analyzers found time to tell CAP TODAY about some of the features they’re planning to unveil in the next year or so.

July 2013—In his 25-year practice career, Texas obstetrician James Maher, MD, has performed several thousand amniocenteses, using a long needle to draw amniotic fluid from the uterus of higher-risk pregnant women to rule out certain fetal chromosomal abnormalities—trisomy 21, or Down syndrome, in particular.

July 2013—After weeks of bewilderment, W. Frank Peacock, MD, finally solved the mystery of one of his so-called frequent fliers in the Emergency Department.

July 2013—When it comes to fighting sepsis, the ingenuity of the laboratory is indispensable.

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

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

Fingerprint and palm scanners, smartphones, Android-based and Apple-based handhelds, multi-use devices. CAP TODAY heard about those and more when it asked lab administrative directors and managers and a few companies about positive patient identification. They told us what they’re doing, what they’re hoping and aiming for, and what’s most in demand. Our questions and their answers follow. On pages 24–30 is our roundup of the positive patient ID, or PPID, market.

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

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

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

June 2013—Lance Peterson, MD, wasn’t expecting to be surprised. But the numbers were dramatic enough to startle even him.

June 2013—When David Scamurra, MD, needed a better, more cost-effective platform for C. difficile testing, he did the only thing he could do: He asked hospital administration to purchase it. And he waited. And waited. “And two years later, they bought the equipment,” he says.

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

June 2013—While pathologists in the U.S. wait—and wait—for the Food and Drug Administration to move toward approving whole slide imaging for primary diagnosis in U.S. laboratories, their neighbors to the north are already celebrating.

They’ve added tests to their menus, tools to their instruments, functionality to their software. Two companies—Alere and Corgenix—introduced new systems. In short, the companies whose immunoassay analyzers are profiled in CAP TODAY’s product guide on pages 18–50 are doing what they can to help labs do what they must.

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

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

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

May 2013—For the past four years, a group of pathologists has been diligently considering one question—Exactly how should whole slide imaging be validated?—all the while knowing that some laboratories consider WSI validation an unnecessary undertaking.

May 2013—Most jobs in the kitchen or the home workshop can be done with a basic set of tools. But every once in a while you need something special—a zester, say, or a dremel—and in those situations it’s nice to have that special tool on hand. Even more important, it’s nice to know how to use it.

May 2013—During the flu season of 2012, patients crowded the emergency room at the University of North Carolina (UNC) Health Care’s Memorial Hospital. They presented with a cough. Congestion. Low-grade fever. In some cases, a sneeze. But in a matter of hours, their clinical pictures diverged: Some patients deteriorated, requiring hospitalization; others remained congested but stable.

“As we move into a health care system driven by more integrated health networks and accountable care organizations, we will see customers wanting to standardize across a test platform to gain economies of scale,” says Jill Downey, Roche Diagnostics’ CoaguChek product marketing manager, professional diagnostics—physician office lab.

May 2013—It seems as though reality TV is taking over the visual airwaves. The shows range from PBS’ traditional and staid “This Old House” to Logo’s “RuPaul’s Drag Race,” in which drag queens are judged by a panel of experts and challenged to “lip-sync for your life.” Who views these shows?

Productivity, collection, analytics, and ACOs are what CAP TODAY asked six marketers and users of lab billing software about in interviews in recent weeks. Here is what they told us.

April 2013—During his six years overseeing fungal proficiency testing and assembling a library of fungal images on behalf of the CAP’s Microbiology Resource Committee, Gordon L. Love, MD, D(ABMM), noticed some-thing: Molds are surprisingly lovely.  

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

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

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

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

April 2013—When 19th-century Hungarian obstetrician Ignaz Semmelweis found that doctors could dramatically decrease puerperal infections by washing their hands with a chlorinated lime solution before delivering babies, his colleagues thought he was nuts. Why, everyone knew that infections were caused by noxious air!

As hospitals and eligible providers work to meet the government’s 2015 deadline for implementing electronic health record systems to comply with the HITECH Act of 2009, are laboratory-provider links (LPL) software companies being left out in the cold?

The newer oral anticoagulants are top of mind not only inside coagulation labs but also for the companies committed to creating coagulation testing solutions. “The rapid introduction of the new oral anticoagulant drugs and expanded indications for existing drugs are driving an urgent need for laboratory testing in cases of unexplained bleeding and surgery,” says Diagnostica Stago’s director of marketing, Hamid Erfanian, who reports that Stago is responding with research-use-only calibrators and controls for several of these drugs to enable rapid, automated testing.

March 2013—In patients with diabetes mellitus, hemoglobin A1c testing frequency is largely in line with recommended guidelines. In those same patients, LDL testing is not performed frequently enough, and urine protein testing frequency falls far short of recommendations.

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

March 2013—For pathologists and clinicians alike, molecular testing can carry shades of a Pinter play: a seemingly straightforward situation with a whiff of discomfort, if not outright menace, and bedeviled by shifting characters and layers of meaning that defy snap interpretations.

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

March 2013—First identified in an HIV patient in 1998, HPV 90 is a genotype of the human papillomavirus that, until now, has received little attention. It is not counted as one of the few well-defined high-risk genotypes, like HPV 16 and HPV 18, that are known to cause the majority of cervical cancer cases.

New to the CAP TODAY lineup of point-of-care blood glucose systems is the Roche Accu-Chek Inform II, which the FDA cleared last fall. It offers meter-level wireless technology, conducts extensive integrity checks with each test, has an advanced laser bar-code scanner, and provides up to three unique patient identifiers. An Other Test Entry feature makes it possible to capture and store results for multiple POC tests.

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

February 2013—Lee VanBremen, PhD, 74, executive vice president of the CAP from 1989 to 2001, died on Nov. 15, 2012 of aspiration pneumonia, a complication of Parkinson’s disease.

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

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

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

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

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

Steve Jobs’ words resonate in all markets: You can’t just ask customers what they want and try to give it to them; by the time you build it, they’ll want something else. That logic is one reason why makers of laboratory automation systems and workcells, the focus of CAP TODAY’s product guide on pages 69–87, strive to offer solutions that meet customers’ needs today while being lithe enough to tackle the challenges of tomorrow.

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

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

January 2013—When James Musser, MD, PhD, and colleagues at Houston’s The Methodist Hospital submitted a study for publication this fall (to “one of the prestigious weeklies based in a northeastern part of the country,” says Dr. Musser), they were prepared to answer questions from reviewers.

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

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

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

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