Top News Stories for the Week of October 12

Help Wanted at COVID-19 Testing Labs

Wall Street Journal

The United States processed more than 1 million daily COVID-19 tests four times in the past week. Such high testing demand is worsening staffing shortages and employee burnout at laboratories, which are investing in automation, hiring more traveling laboratory scientists, and sometimes raising salaries and making schedules more flexible, according to lab specialists. David Grenache, PhD, chief scientific officer at TriCore Reference Laboratories in New Mexico and president of the American Association for Clinical Chemistry, says: "I can replace hardware and I can manage not having enough reagents, but I can't easily replace a qualified technologist." Laboratories that lack sufficient staff tend to restrict the volume and types of testing they do, says Brandy Gunsolus, DCLS, a laboratory manager at Augusta University Medical Center in Georgia. The shortages can also prolong turnaround times for test results. There are roughly 337,000 clinical laboratory technologists and technicians working in hospital, public-health, and commercial labs nationwide, the U.S. Bureau of Labor Statistics estimates. In August, 58 percent of labs surveyed by the American Association for Clinical Chemistry cited staffing as a problem, up from 35 percent in May. Certain states including New York and California require technologists to obtain a state-specific license; however, both states waived that requirement at the beginning of the pandemic.

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A 25-Year-Old Man Becomes First in the U.S. to Contract Coronavirus Twice


A new report details the case of a young man from Nevada who contracted SARS-CoV-2 on two different occasions, the first confirmed case of a U.S. patient becoming reinfected with the virus and the fifth case reported worldwide. The man, aged 25 years, had no known immune disorders or history of significant underlying conditions but required hospital treatment on testing positive for the virus the second time. According to the report, detailed in The Lancet Infectious Diseases, the man has since recovered, but the case raises questions about the idea of developing protective immunity against the virus. The young man first tested positive in April of this year, and his symptoms fully resolved during isolation by the end of the month. He then tested negative for the coronavirus twice in May. He began to experience symptoms again from May 28, and on June 5 tested positive again, with doctors saying his condition was symptomatically "more severe" than the first infection. A comparison of the genetic codes indicated there were "significant differences" between each variant related to each instance of SARS-CoV-2 infection. "These findings suggest that the patient was infected by SARS-CoV-2 on two separate occasions by a genetically distinct virus. Thus, previous exposure to SARS-CoV-2 might not guarantee total immunity in all cases," the study authors said. "All individuals, whether previously diagnosed with COVID-19 or not, should take identical precautions to avoid infection with SARS-CoV-2," they noted.

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CMS Takes Action to Protect Integrity of COVID-19 Testing

CMS Press Release

Since August 12, 2020, the Centers for Medicare & Medicaid Services (CMS) has issued 171 cease-and-desist letters to facilities that did not have proper Clinical Laboratory Improvement Amendments of 1988 (CLIA) certifications. Every facility that conducts COVID-19 testing is deemed a "laboratory" that must be certified under CLIA. Soon after the onset of the pandemic, CMS launched an expedited review process to assist laboratories with the application process, in addition to a newly released quick-start guide. Of CMS' 171 letters, a third went to facilities conducting laboratory testing without a CLIA certificate and two-thirds were issued to laboratories performing COVID-19 testing outside of the scope of the existing CLIA certification. The letters ordered these laboratories to immediately halt operations to protect the integrity of COVID-19 testing and safeguard patients from potentially inaccurate or unreliable test results. Laboratories that receive cease-and-desist letters must furnish CMS with an attestation certifying they have stopped testing. CMS' letters also give non-certified laboratories information on how to become CLIA certified so they can resume testing.

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