May 2019

May 2019—When Monica Rocheford and colleagues at Allina Health Laboratory first began digging into rising turnover rates at various locales within the system, the effort carried a whiff of concern, if not urgency. One hospital site had jumped from a 10.8 percent turnover rate in 2016 to 44.9 percent two years later. At another site, turnover reached 49 percent in 2018, from 24 percent the year before. The culprit appeared to be a three-letter word: pay. “That was the main reason they were giving us for their resignation,” says Rocheford, system director, laboratory operations, recalling the exit interviews with departing staff. So in 2018, Allina, with nearly 1,000 lab employees (spread across 12 hospitals, a core lab, and roughly 60 clinics in Minnesota and western Wisconsin), awarded a technical increase across the board.

May 2019—If a futurist had forecast 10 years ago that, in 2019, a compound of the cannabis plant would be sold over the counter and online and consumed for health reasons by an estimated quarter of the U.S. adult population, most people would have scoffed at the suggestion.

May 2019—Chronic lymphocytic leukemia is a neoplasm of small mature B-cells and the most common leukemia diagnosed in adults. Median age of diagnosis is 70 years, but there is a surprisingly large percentage of patients, about 10 percent, who are younger than 55, and it’s not uncommon now to occasionally see CLL patients, about two percent, in their 40s.

May 2019—Never go it alone without the input of the ordering clinician, and the diagnostic yield is better than expected. Those are two of the five lessons UCLA learned in its first seven years of clinical whole exome sequencing.

May 2019—If a mass casualty event brings patients to Le Bonheur Children’s Hospital in Memphis, Tenn., clinical laboratory staff will head straight to the bedside. Le Bonheur Children’s Hospital is a level-one trauma center. Its new mass casualty response plan, two years in the making, has laboratory staff in the emergency department and triage areas, where they will perform point-of-care testing for frontline providers.

May 2019—CAP Press released this month its second edition of Laboratory Administration for Pathologists, first published in 2011. It covers management of personnel, laboratory space, pathology information systems, and quality in laboratory medicine and in the anatomic pathology lab. That’s just to start. Among its other chapters: patient safety, the pathology position, lab laws and regulations, legal affairs, ethics, and financial management of the lab and of the pathology practice. And there is more in the 296-page book edited by Elizabeth A. Wagar, MD, Michael B. Cohen, MD, Donald S. Karcher, MD, and Gene P. Siegal, MD, PhD. CAP TODAY recently asked Dr. Wagar about the latest edition; what she told us appears here, along with an excerpt (at right). Dr. Wagar is professor and chair, Department of Laboratory Medicine, University of Texas MD Anderson Cancer Center.

May 2019—A new CAP Q-Probes benchmarking study on expression rates in invasive breast carcinoma will be available beginning in June.

May 2019—Non-small cell lung cancer patients with epidermal growth factor receptor activating mutations have excellent response to oral therapy with EGFR tyrosine kinase inhibitors. However, development of resistance to first- and second-generation TKIs is a well-recognized phenomenon with acquired p.T790M mutation and accounts for most TKI drug resistance. Resistance to EGFR TKI therapy has been described in tumors with coexistent primary p.T790M mutation and an EGFR activating mutation in a small number of patients.

May 2019—Workflow, data interpretation, communication, and community—that and more came up when CAP TODAY publisher Bob McGonnagle spoke with five NGS experts in April: Boaz Kurtis, MD; Zhiyv (Neal) Niu, PhD; David Eberhard, MD, PhD; Luca Quagliata, PhD; and Arnaud Papin, MSc, MBA. What they said follows.

May 2019—The genomic landscape of non-small cell lung carcinoma is evolving constantly with the discovery of a growing number of molecular alterations and associated targeted therapies that have an impact on patient care. The CAP, International Association for the Study of Lung Cancer, and Association for Molecular Pathology issued a guideline in 2013 to provide a road map for molecular testing to select patients for treatment with targeted tyrosine kinase inhibitors.

May 2019—The CAP regularly surveys the practices of the laboratories participating in the CAP Nongynecologic Cytopathology Education Program, or NGC. Members and staff of the CAP Cytopathology Committee developed a supplemental questionnaire eliciting feedback on pathologist competency activities. The Survey was mailed to 2,142 participants in the NGC-B 2018 education program. The pathologist competencies queried were as follows:

May 2019—In the November-December 2018 issue of the Journal of the American Society of Cytopathology is a fascinating analysis of human papillomavirus screening policies in Australia by researchers from New Zealand, a rebuttal by members of an Australian Cervical Cancer Screening Guidelines Working Party, and a thoughtful editorial by cervical cancer screening experts from the United States and England.

Early Sepsis Indicator receives 510(k) clearance
May 2019—Beckman Coulter’s Early Sepsis Indicator received 510(k) clearance from the Food and Drug Administration. Beckman Coulter says clinical trial findings showed that its monocyte distribution width biomarker best discriminated sepsis from all other conditions when combined with the current standard of care. The Early Sepsis Indicator is automatically reported as part of a routine complete blood count with differential for adult emergency department patients. A positive Early Sepsis Indicator result signals a higher probability of sepsis. Compared with reviewing WBC count alone, Beckman Coulter says the Early Sepsis Indicator strengthens a clinician’s suspicion of sepsis by 43 percent and, together with clinical signs and symptoms, improves confidence in helping to rule out sepsis by 63 percent. The indicator can be used in conjunction with the company’s Multidiscipline Reflex Rules in Remisol Advance middleware.

Q. Are there any FDA-approved laboratory-developed assays or point-of-care assays for detecting oxycodone or fentanyl in urine or blood? Read answer. Q. What was the cause of a sudden shift in values in the triglyceride assay at one clinical laboratory? Read answer.

May 2019—Excel tool color codes persistent  problems in lab test ordering: Variety may be the spice of life, but in the pathology lab, it may present a conundrum. Case in point: The LIS is a rich source of data about lab test utilization, but managing millions of disparate pieces of data to assess test utilization can be difficult. But not to Tylis Y. Chang, MD, of Northwell Health.

May 2019—The CAP Center for Pathology and Laboratory Quality for Evidence-Based Guidelines has partnered or collaborated with more than 20 societies to produce 15 published laboratory practice guidelines—with 10 more underway. The Center is one of the best things we do and one of the things we do best.One thing about the CAP: We make no small plans. It was that way when we decided to inspect and then accredit laboratories. It was that way when we decided to hold an independent annual meeting. And it was that way when the CAP Center had its first official guidelines published in Archives of Pathology & Laboratory Medicine.

May 2019—Optimization of laboratory ordering practices for CBC with differential: Over 5 billion laboratory tests are performed in the United States each year, and more than 20 percent are considered unnecessary. The American Board of Internal Medicine Foundation initiated the Choosing Wisely campaign in 2012 to increase awareness of wasteful or unnecessary medical tests, procedures, and treatments. Studies have shown that tests ordered without a clear rationale not only waste resources but are also a source of iatrogenic anemia, which has been associated with increased blood transfusions, lengths of stay, and mortality.

May 2019—ALK-rearranged tumors in the STUMP subcategory of uterine tumors: Smooth muscle tumor of uncertain malignant potential is a rare diagnosis rendered when there is uncertainty concerning the biological potential of a smooth muscle tumor. The initial differential diagnosis is often broad, as tumors in this subgroup are morphologically heterogeneous. Recent data suggest that uterine inflammatory myofibroblastic tumors (IMTs) with anaplastic lymphoma kinase (ALK) rearrangement may be misclassified as smooth muscle tumor of uncertain malignant potential (STUMP), but the extent to which this occurs has not been examined.

May 2019—Diagnosing and targeting pancreatic cancer at the single-cell level: Pancreatic ductal adenocarcinoma is a highly aggressive cancer that is often unresectable at the time of diagnosis. It also is frequently metastatic and associated with a high mortality rate. One approach to reduce the poor outcomes associated with this disease could involve early detection and treatment of the cancer before it develops the ability to invade and spread to other organs.