Clinical Laboratories in Hospitals Continue to Experience Reductions in Test Orders as Emergency Department Visits for Common Conditions Slowly Climb Back to Pre-Pandemic Levels

Multiple recent studies reveal a substantial number of patients continue to delay needed healthcare in the months since the onset of the SARS-CoV-2 outbreak Based on an analysis of hospital emergency department (ED) usage, federal researchers concluded that patients continue to be cautious when visiting healthcare providers, including clinical laboratories, and that people are altering how they seek and utilize emergency care due to the COVID-19 pandemic. This not only reduces the number of...

CMS Proposes a New Rule That Would Shift Many Procedures from High-Cost Inpatient Healthcare Settings to Lower-Cost Outpatient Ambulatory Surgical Centers

If the proposed rule becomes final, it may shift some inpatient medical laboratory testing away from hospital labs and to independent clinical laboratories Medical laboratories in hospitals and health systems already feel the pinch of less test orders originating from their own emergency departments (ED). Now, more tests associated with inpatient care might also shift away from hospital labs due to a new proposed rule from the federal Centers for Medicaid and Medicare Services (CMS) that would...

UCSF and Stanford Researchers Investigate Why Some Infected with COVID-19 Are Asymptomatic, While Others Become Severely Ill or Die

Might clinical laboratories soon be called on to conduct mass testing to find people who show little or no symptoms even though they are infected with the coronavirus?     Clinical laboratory managers understand that as demand for COVID-19 testing exceeds supplies, what testing is done is generally performed on symptomatic patients. And yet, it is the asymptomatic individuals—those who are shown to be infected with the SARS-CoV-2 coronavirus, but who experience no symptoms of the illness—who...

New Research Suggests Clinical Laboratory Blood Tests Could Fill A Void in Alzheimer’s Disease Diagnoses

Studies presented at the Alzheimer’s Association International Conference point to the p-tau217 protein as an especially useful biomarker Researchers disclosed a potentially useful biomarker for Alzheimer’s Disease at a major conference this summer. The good news for clinical laboratories is that the biomarker is found in blood. If further research confirms these early findings, medical laboratories could one day have a diagnostic test for this condition. That possibility emerged from the...

Though Two Analyst Reports Show Depressed Operating Margins for Healthcare, Providers and Clinical Laboratories May See Patient Volumes Rise for the Rest of 2020

  July data shows some volume gains for providers since June; however, analysts say current predictions depends on progress of the COVID-19 pandemic Clinical laboratory managers preparing strategic plans for 2020 and 2021 face a basic and key question: when and if they can expect patient volumes and associated lab test referrals to return to pre-COVID-19 pandemic levels. Some insights into how to answer that question can be found in two separate reports. Separately, healthcare analysts...

Individual EUAs for Molecular Diagnostic Tests for SARS-CoV-2

This table includes information about authorized SARS-CoV-2 molecular diagnostic tests. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. (Source: FDA.gov) Visit our Lab Resource Center. Date EUA IssuedManufacturerDiagnostic (Letter of Authorization)TechnologyAuthorized Setting(s)Authorization Documents: EUA Summary 9/9/2020Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.Wantai...