Tag Archives: Lab test utilization management

January 2024—Sometimes even superb ideas can also turn out to be quite, well, bothersome. Zoom meetings. Bridal showers. Bike lanes. Parking apps. QR menu codes. And—if laboratories aren’t careful—the same can be true of pharmacogenomic testing. Just ask Ann Moyer, MD, PhD, associate professor, laboratory medicine and pathology, Mayo Clinic. When it comes to pharmacogenomic testing, laboratory medicine brings significant expertise to the table. But in clinical settings, physicians who prescribe the medications need to be familiar with how to use the test results. They also need to work with the lab to decide which tests, for which genes or gene-drug pairs, will be most helpful for their patients, she says. “Especially if you’re going to start incorporating clinical support alerts into the EHR,” adds Dr. Moyer, who was chair of (until Dec. 31; she is now advisor to) the CAP/ACMG Biochemical and Molecular Genetics Committee. “If the practice doesn’t actually want them, then you’re just going to end up annoying them.”

January 2024—Thrombophilia testing has been shown to be performed far more often than indicated in thromboembolic events, at significant cost to the patient and hospital.

December 2023—The recent CAP proficiency testing questionnaire was meant to be the coup de grâce. Hematology PT participants were asked about their band neutrophil reporting practices and, given that these manually generated counts were supposedly on their way out decades ago, the authors of the survey questionnaire expected to see very little activity. The survey, they hoped, would be a way to pound the final, data-driven nail in the coffin. Or, as lead author Maria (Ria) Vergara-Lluri, MD, puts it, “We thought this had all been laid to rest 30 years ago.” It wasn’t. Says Dr. Vergara-Lluri: “Surprise: 86 percent of labs that participated still report bands.” The results of the survey upended many of the assumptions, if not hopes, the authors might have had. Among laboratories that reported manual differentials, they found that most reported bands (4,554 of 5,268). Moreover, only 73 percent reported band reference ranges. On the morphologic challenge, bands classified as “easy” were indeed easy—participants classified them well.

December 2023—The third and latest edition of recommendations for laboratory analysis in diagnosing and managing diabetes mellitus, released this summer, provide guidance on, among other things, ketone testing, glycolysis, and point-of-care testing. The last such recommendations were published in 2011.

November 2023—At the point of care, there are testing wins, some losses, and plenty of pitfalls. “Point-of-care coordinators all have the same problems,” says Meaghan Gladstone, applications consultant at Werfen.

October 2023—With respiratory virus season near, those with a close eye on it in August gave the lay of the land for test algorithms, technologies, and forecasts, even as SARS-CoV-2 and RSV cases were rising in parts of the country.

September 2023—For the tickborne and mosquito-borne arboviruses, which are frequently more transient in blood and tissue than other pathogens, both molecular and serologic testing have a place in the diagnostic toolkit.

May 2023—Of the five methods used to measure HbA1c—immunoassay, boronate affinity, enzymatic, capillary electrophoresis, and ion-exchange HPLC—only the latter two can alert the laboratory and physician to the presence of a suspected hemoglobin variant. Even so, there are reasons to be cautious.

April 2023—Celiac disease incidence is up and the diagnostic rate is low, and it can be years from onset of symptoms to diagnosis. “It’s a long diagnostic odyssey, and so in the laboratory business, we’re all in to help,” says Annette Taylor, MS, PhD, associate vice president at Labcorp where she is strategic director of pharmacogenomics and scientific director of molecular genetics.

February 2023—Like a thriving expat, Deborah Dillon, MD, is comfortable moving within worlds both old and new. Specifically, as a breast and molecular pathologist at Brigham and Women’s Hospital, she appreciates the biomarkers she and her colleagues grew up with, so to speak, as well as those that are part of a more recently arrived-at scenery. Not everyone finds both worlds equally riveting. “A lot of people are much more interested in, and excited by, new markers,” she says. “When I talk to people from pharma, this is what they want to hear about.” So do many pathologists, oncologists, and patients—new markers and new therapies have a way of updating hopes. Dr. Dillon understands the persistent thrill of the new, why people want her to talk the language of PIK3CA, PARP inhibitors, MMR, NTRK fusions, ESR1, and the like. But as an in-demand speaker as well as in a recent interview with CAP TODAY, she also advocates for making the old—the longstanding trinity of ER, PR, and HER2—seem new again.

February 2023—Traditional algorithm? Or reverse? Elitza Theel, PhD, D(ABMM), of Mayo Clinic, in an AACC session last year walked through the two primary diagnostic algorithms for syphilis, explaining where the complexities lie and how her laboratory uncovered inappropriate testing for neurosyphilis.

February 2023—Consensus on the best ways to stem unnecessary laboratory testing, and spare health care systems and patients its negative effects, is still elusive.

January 2023—Laura Esserman, MD, MBA, can still recall her Eureka moment. She had just seen a talk on residual cancer burden by pathologist W. Fraser Symmans, MB.ChB, a pioneer in the field. “When I saw Fraser present this,” says Dr. Esserman, director, University of California San Francisco Breast Care Center, “I knew immediately that MRI would work and that residual cancer burden would complement it. MRI was basically a snapshot of RCB over time. I realized that we had to institute RCB—we had to standardize our approach.” Until then, she and her colleagues across the I-SPY trial sites relied on individual pathologist assessment for each case. The pathologic complete response rate, or pCR, hovered at about 34 percent. That insight was soon followed by another. Intrigued by what she heard, Dr. Esserman and her pathologist colleagues from all the I-SPY sites traveled to MD Anderson, where Dr. Symmans helped develop the residual cancer burden system, for training.

January 2023—Guidelines for the diagnosis of von Willebrand disease, published in 2021, have raised questions about which von Willebrand factor activity assay laboratories should use.

January 2023—For the central microbiology laboratory serving Barnes-Jewish and four other hospitals in the St. Louis area, validating and implementing a new blood culture system and moving to a shorter incubation time came at a perfect time: right before the pandemic.

December 2022—The Centers for Medicare and Medicaid Services published on Nov. 1 its final 2023 Medicare physician fee schedule with payment rates and new policies set to take effect next year.

October 2022—HER2-low breast cancers are now of greater clinical interest, given Enhertu’s recent approval for use in treating such cancers. How to achieve accurate and reproducible results in scoring HER2-low tumors was at the center of a CAP TODAY webinar on new perspectives on the full spectrum of HER2 expression in breast cancer.

July 2022—Variability in testing for monoclonal immunoglobulin proteins was in part what led to the new guideline on laboratory detection and initial diagnosis of monoclonal gammopathies, published in May.

June 2022—The latest advance in breast cancer treatment is a big one—the promising antibody drug conjugate fam-trastuzumab deruxtecan-nxki, or T-DXd (Enhertu). The drug was granted break­through therapy designation this spring for patients with HER2-low metastatic breast cancer, and the drug and trial on which the decision was based were the focus of the plenary session at the ASCO annual meeting in early June. “This drug in particular is a variant of a drug we are all very familiar with—Herceptin, or trastuzumab,” says David Rimm, MD, PhD, the Anthony N. Brady professor of pathology, professor of medicine (oncology), director of the translational pathology and Yale pathology tissue services, and director of the physician scientist training program in pathology, Department of Pathology, Yale University School of Medicine. Also familiar: the IHC test to determine eligibility for the drug, a companion diagnostic developed decades ago. But that’s where easy familiarity ends.

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.

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.”

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.