December 2020

December 2020—By its very nature, the global pandemic has forced laboratories to look far and wide, to bring binoculars, in essence, to their views of supply chains, testing platforms, personnel, and the like. As COVID-19 churns on, some labs are looking through a tinier lens as well. These labs aren’t trading their binoculars for a jeweler’s loupe, exactly, but they have found small and significant success stories closer to home. Like so many others, Erin Graf, PhD, D(ABMM), has confronted a spinning roulette wheel since the pandemic’s start. In a talk she gave in an AMP webinar in October, Dr. Graf posted a vibrantly colored wheel titled, “Which supply chain issue will impact us this week?” Each segment contained a phrase familiar to everyone in 2020, ranging from “swabs” and “sheep blood agar” to “pipette tips” and “chlamydia and gonorrhea tests.” As she surveys these continuous claims on her attention, Dr. Graf says, “I think none of us could have ever thought that COVID would have an impact on all these arms of the testing that we do.”

December 2020—As ongoing studies reveal the merits of emicizumab for hemophilia A patients—fewer bleeding episodes, longer duration between treatments—laboratories need to be alert to the drug’s effect on coagulation testing.

December 2020—Always think about timing, maintain a log of malfunctions, and make the right decision the easy decision. These are a few of the clinical decision support tips that Ronald Jackups Jr., MD, PhD, and Amanda Blouin, MD, PhD, presented last month in a CAP20 session.

December 2020—In Colorado, Joan Coleman, MBA, MT(ASCP), and her UCHealth colleagues launched an expansive pooled testing program this summer that, after much work, worked well—until it didn’t, thanks to rising positivity rates in October.

December 2020—In an evaluation performed at Washington University in St. Louis and published recently, BioFire’s FilmArray pneumonia panel was found to have strong agreement with standard-of-care methods in identifying viral and bacterial targets in 200 lower respiratory tract specimens (Webber DM, et al. J Clin Microbiol. 2020;58[7]:e00343–20). It was also found to have strong agreement with the BioFire upper respiratory panel for common targets, making it unnecessary to perform both. In comparison to standard-of-care methods, it has the potential to detect more Staphylococcus aureus and Haemophilus influenzae and to detect more antimicrobial resistance, particularly at low organism concentrations or in mixed cultures.

December 2020—Circulating cell-free DNA in the blood of pregnant women is derived from both maternal tissues and the placenta.¹ As a result, cfDNA isolated from maternal plasma can be used for noninvasive prenatal screening (NIPS) to identify fetal autosomal aneuploidies (trisomies 13, 18, and 21) and sex chromosome aneuploidies (SCAs). For fetal autosomal aneuploidies, NIPS offers higher detection rates and lower false-positive rates than traditional screening methods, such as maternal serum screening and nuchal translucency.² NIPS is the only screening option available for SCAs, such as Turner syndrome (45,X) and Klinefelter syndrome (47,XXY), which do not pre­sent with ambiguous genitalia on fetal ultrasound.³

December 2020—The Compass Group reconvenes to share the latest on SARS-CoV-2 testing—this time on Oct. 6 and again by Zoom. What they said about supplies, labor, and flu follows. Serology testing too: “It’s the one test we have loads of and the one test they don’t use a lot of,” said Heather Dawson of Allina Health in Minneapolis. CAP TODAY publisher Bob McGonnagle led the roundtable. With Dawson were Walter Henricks, MD, of Cleveland Clinic; Jennifer Laudadio, MD, of the University of Arkansas for Medical Sciences; Joseph Baker of Baylor Scott & White; Judy Lyzak, MD, MBA, of Alverno; Susan Fuhrman, MD, of OhioHealth; Dan Ingemansen and Rochelle Odenbrett, MT(ASCP), MBA, of Sanford Health; Janet Durham, MD, of ACL Laboratories; Diana Kremitske, MS, MHA, MT(ASCP), of Geisinger; Darlene Cloutier, MSM, MT(ASCP), HP, of Baystate; Stan Schofield of NorDx; Clark Day of Indiana University Health; Tylis Chang, MD, of Northwell; and John Waugh, MS, MT(ASCP), of Henry Ford. The Compass Group is an organization of not-for-profit IDN system lab leaders who collaborate to identify and share best practices and strategies.

December 2020—What could improve urinalysis operations in your laboratory? That’s a question CAP TODAY publisher Bob McGonnagle asked Megan Nakashima, MD, of the Cleveland Clinic when she talked in October with him and two others: Carl Trippiedi of Sysmex and Matt Rhyner, PhD, MBA, of Beckman Coulter. Their conversation took place as CAP TODAY’s 2020 product guide to urinalysis instrumentation was taking shape. What they had to say follows.

December 2020—As we reach the end of December, I am taking a look back at this year and wondering: How long was 2020 anyway? My calendar says 12 months, but if you’re like me, 2020 seems like it has already had about 24 in it and I’m still counting. I’ve even taken to using “2020” as an expletive. When I think of the key themes of the past year, most are quite negative. The pandemic, virtual meetings, and extremely challenging legislation just to name a few. In the spirit of hoping the worst is behind us—and to remind ourselves how much we worked to make the best of a bad situation—let’s take a quick tour of the major difficulties we faced in 2020.

December 2020—The National Academy of Medicine estimated that approximately 30 percent of U.S. health care spending constitutes nonvalue-added waste. This waste may be generated through unnecessary laboratory tests and services, inefficiency of care delivery, ex­cessive administrative costs, and high prices. A goal of medical educators is to inform undergraduate medical students about health care management and health care delivery to make them better stewards of cost-effective, high-value care (HVC). The authors described the results of a needs analysis to inform the design of an online case-based educational tool for teaching laboratory stewardship to medical students. To this end, they conducted a needs assessment that included semi-structured interviews of core clerkship directors and residency program directors, a national survey of the Undergraduate Medical Educators Section of the Association of Pathology Chairs, and a review of existing online resources for teaching HVC. Their results showed that all of the core clerkship directors and residency program directors thought that teaching laboratory stewardship as part of the undergraduate medical education (UME) curriculum was important. The two major themes that emerged from the analysis to enhance laboratory stewardship education were appropriate test ordering and interpretation. The authors also found several organizations that provide HVC education through online modules or clinical cases.

December 2020—It can be difficult to distinguish metastatic melanoma from melanocytic nevi in lymph nodes. Because diffuse IHC PRAME (preferentially expressed antigen in melanoma) expression is detected in the majority of primary and metastatic melanomas, but rarely in nevi, the authors conducted a study in which they hypothesized that PRAME could be a useful adjunct marker for the diagnosis of melanocytes in lymph nodes. They examined 45 nodal melanocytic deposits comprising 30 nodal nevi and 15 melanoma metastases. The latter were not straightforward from a diagnostic perspective because they coexisted with nodal nevi or were present in perinodal fibrous tissue. All nodal nevi were negative for PRAME and all melanoma metastases were diffusely positive for PRAME IHC.

December 2020—Next-generation sequencing-based mutation testing of various cancer types is clinically indicated and widely used to diagnose disease, inform potential therapeutic targets, prognosticate disease course, and monitor responses to targeted and nontargeted therapies. The genetic variants discovered by tumor-based next-generation sequencing (NGS) can be somatically acquired by the neoplastic cells or a fixed inherited component of the patient’s germline genome. Distinguishing the germline versus somatic status of tumor NGS-defined variants is of significant clinical importance not only for patient care but possibly for patients’ families. Because many cancers have a substantial inherited component, the discovery of a pathogenic germline mutation by tumor-based NGS may have substantial familial implications. For example, being aware of a cancer risk allele, such as BRCA1, can lead to the use of highly effective interventions to prevent or treat the related cancer in family members. Consensus guidelines recommend germline genetic testing only for those cancer patients who have a clinical presentation or family history suggestive of hereditary disease.

Q. Can a heel stick for a basic metabolic panel with magnesium and phosphorus be performed on a two-month-old baby? Read answer. Q. Due to nationwide supply shortages affecting COVID-19 and other testing in the laboratory, we are concerned about using up critical supplies when assessing competency. Do you have suggestions or strategies we can use? Read answer. Q. When a patient is admitted to our hospital, we collect MRSA nares PCR, MRSA axilla by culture, MRSA groin by culture, and vancomycin-resistant Enterococcus by PCR for infection control purposes. Many surrounding facilities have told us they have removed the axilla and groin cultures, but no references were cited to support removing these procedures. Our facility would like to follow the practices of other hospitals, but our providers would like a reference to cite. Are there best practices or benchmarks from an infection control and microbiology point of view that would allow us to remove the axilla and groin MRSA screen cultures? Read answer.

New NovoPath CEO settled in and taking questions December 2020—CAP TODAY publisher Bob McGonnagle recently spoke with Promise Okeke, who took the helm as CEO of NovoPath last summer. Here’s what Okeke had to say about NovoPath’s case distribution module, customer service, and the advantages of offering a best-of-breed system, among other topics.

December 2020—Antimicrobial Susceptibility Testing: Monitoring and Trend Analysis is a new CAP program that is beginning to roll out to laboratories this month. The CDC guidance for antibiotic stewardship consists of seven core elements to address resistance-associated risks, one of which points to the importance of laboratory collaboration, communication, and AST reporting practices to the success of stewardship programs. According to this core element, the laboratory must provide information to guide discussions on the potential implementation of test interpretive criteria, such as changes in antibiotic breakpoints, that might affect antibiotic use.