February 2019

February 2019—Digital pathology is many things. One thing it’s not is a one-night stand. As laboratories contemplate using digital pathology for primary diagnosis in the wake of the FDA’s approval nearly two years ago, it’s become abundantly clear that while digital pathology might seem to promise easy pleasure, it’s actually as complicated as keeping multiple spouses happy. Think Jacob, Rachel, and Leah. Think “Big Love.”

February 2019—A forgotten creditor. A poor relation. An envious rival. In the theater, one of these characters often emerges from the woodwork, ready to supply a plot twist just when the protagonist is riding highest.

February 2019—Two breast cases—one of apocrine carcinoma and androgen receptor overexpression and another of metastatic ER-positive cancer and an ESR1 mutation—were the focus of a molecular oncology tumor board session at CAP18.

February 2019—Mass spectrometry has been proved to be an essential and powerful platform for clinical diagnostics. The value it adds to health care has increased steadily in the past decade.

February 2019—In one case, Dr. Ribes found herself intrigued by structures in a patient’s urine cytology specimen. A 36-year-old man from the Republic of Congo had developed dysuria, increased urinary frequency, and terminal hematuria. What they found in the Pap stain in cytology, she said, were large purple structures with the knob at the end.

February 2019—Lung cancer is the second most commonly diagnosed malignancy and results in the most cancer-related deaths each year in the United States, but actionable aberrations in EGFR, ALK, ROS1, and other oncogenes are improving outcomes for a subset of patients.

February 2019—When Tania Hong, BS, MT, joined the University of Vermont Medical Center five years ago, as network director of operations for pathology and laboratory medicine, she interviewed all of the supervisors in her laboratory. She asked what they saw as their biggest challenges.

February 2019—Practice consolidation and complexity, Web-based and cloud computing, and artificial intelligence. That and more is what writer Valerie Neff Newitt asked six AP-LIS companies about recently. Here is what they had to say. The profiles of their AP information systems are in the Anatomic pathology product guide, along with those of 16 other companies.

February 2019—Logical Observation Identifiers Names and Codes, or LOINC, is a universal code system for identifying laboratory and clinical observations. LOINC provides unique numeric codes that identify the type of in vitro diagnostic test with defined attributes including component, property, time, system, scale, and method.

February 2017—In a context where the lack of drugs against resistant bacterial pathogens will continue and antimicrobial prescriptions are highly complex, effective antibiotic stewardship programs are strongly needed. In the U.S., the CDC and Centers for Medicare and Medicaid Services highly recommend, while the Joint Commission requires, that all hospitals and nursing care centers have antimicrobial stewardship programs, effective January 2017.

Hologic assay is first FDA-cleared test to detect M. genitalium
February 2019—The Food and Drug Administration granted clearance for Hologic’s Aptima Mycoplasma genitalium assay. This is the first test the FDA has authorized for M. genitalium detection. The FDA reviewed data from a clinical study that included testing of 11,774 samples. The FDA says the study showed that the Aptima assay correctly identified M. genitalium in approximately 90 percent of vaginal, male urethral, male urine, and penile samples. It correctly identified M. genitalium in female urine and endocervical samples 77.8 percent of the time and 81.5 percent of the time, respectively. Vaginal swabs are the preferred sample type owing to better clinical performance. Alternative sample types, such as urine, can be used if vaginal swabs are not available. In addition, the study showed that the test correctly identified samples that did not have M. genitalium present 97.8 to 99.6 percent of the time. The FDA reviewed the Aptima M. genitalium assay through the de novo premarket pathway.

Q. When performing a manual differential that contains immature cells, such as metamyelocytes and myelocytes, do you report an absolute count on all of the individual cells in the myelocytic line, or do you group them together and calculate one ANC? What about lymphocytes and reactive lymphocytes? Read answer. Q. Why and in what employment screening settings is the two-step skin test for Mycobacterium tuberculosis recommended? Read answer.

February 2019—In last month’s column, we talked about practice engagement as an umbrella term for laboratory medical direction and practice management that builds strong relationships within and beyond the laboratory. The CAP Practice Management Committee has been taking the lead on this, but it cuts across multiple domains; the conundrum, as always, is the complexity of what we do. Practice management tools designed for other settings cannot meet our needs because we must address economy, efficiency, effectiveness, and collegiality concerns specific to pathology. But then, affinity for complexity is how we landed here in the first place, so that plays to our strengths.

February 2019—Impact of commercial laboratory testing on a care delivery system: Care delivery systems have become increasingly fragmented and complex, which impacts patient care. The amount of health care data generated has also created a problem by reducing the time devoted to direct patient care.

February 2019—Diagnostic algorithmic proposal based on IHC evaluation of invasive endocervical adenocarcinomas: The International Endocervical Adenocarcinoma Criteria and Classification was developed to separate endocervical adenocarcinomas into two main categories based on morphology: human papilloma virus-associated (HPVA) and nonhuman papilloma virus-associated adenocarcinomas.

February 2019—Evaluation of mutational processes and somatic driver mutations in cancer exomes: As next-generation sequencing-based tumor profiling gains popularity, multiple informative variables other than single-gene alterations will continue to be added to clinical reports.

February 2019—Digital pathology RFPs: from the questions to selections: To those who request the information and those who supply the information, requests for proposal, better known as RFPs, can be groanworthy. Yet laboratories planning to purchase a digital pathology system for clinical use should seriously consider going through the painstaking process, even if their institutions don’t require it, says Liron Pantanowitz, MD, vice chair of pathology informatics at the University of Pittsburgh Medical Center.