Review: Thousands of coronavirus tests are going unused in US labs

Review: Thousands of coronavirus tests are going unused in US labs

A report in Nature finds that many university laboratories that have been certified to test for the virus that causes COVID-19 are not being used to capacity by hospitals/clinics due to incompatible electronic health record software (EHR) or lack of contracting/billing mechanisms.

The Broad Institute of MIT and Harvard has been approved to do 2000 tests a day but are only doing 1000 a day, even though they, like many other university laboratories have spent thousands of dollars to transform their laboratory into testing centers who can process tests using the PCR technique. Even though these laboratories can often give results much faster than clinical laboratories, they are not being used to capacity.  The report notes that many hospitals are using the diagnostic companies they are used to dealing with, even though their results may take up to seven times as long as the academic laboratories. The US Food and Drug Administration allowed academic laboratories to start coronavirus testing as long as they had a Clinical Laboratory Improvement Amendments (CLIA) certification. Because many of these laboratories did not have CLIA certification, they often partnered with other entities with such certification. However, even after going through this process, there were issues of lack of compatibility of EHRs and difficulty in billing for such tests. As a result, clinics and hospitals are often not utilizing these types of academic laboratories, and some laboratories are offering their tests in the community to first responders in order to get more people tested. There is also a concern about which tests to use. The World Health Organization testing protocol has been adopted by some laboratories who are concerned about the efficacy of the Center for Disease Control’s tests, but they are running into issues of missing needed components of testing due to worldwide shortages.

|2020-04-09T16:50:34-04:00April 9th, 2020|COVID-19 Literature|Comments Off on Review: Thousands of coronavirus tests are going unused in US labs

About the Author: Seema Mohapatra

Seema Mohapatra
Seema Mohapatra is an Associate Professor of Law and Dean's Fellow at the Indiana University Robert H. McKinney School of Law, She teaches Introduction to Health Care Law and Policy, Genetics and the Law, Torts, and Bioethics and the Law. Seema Mohapatra is an expert in the areas of health care law, public health law, bioethics, torts, and international health and family law. Her research interests include the intersection of biosciences and the law, assisted reproduction and surrogacy, international family and health law, health care disparities in the United States, and informed consent. Her work has been published in several journals, including the Wake Forest Law Review, Colorado Law Review, Brooklyn Law Review, and the Harvard Journal of Law & Policy. Professor Mohapatra currently teaches Torts, Introduction to Health Care Law, Bioethics, and Genetics and the Law. She has authored articles and book chapters on topics such as insurance coverage of infertility and assisted reproduction, genetics and health privacy, international surrogacy laws, and equity in healthcare coverage. Professor Mohapatra regularly presents her research nationally and internationally at legal and medical conferences and symposia. Prior to teaching, Professor Mohapatra practiced health law in Chicago at Sidley & Austin and Foley & Lardner. She earned a J.D. degree from Northwestern University School of Law and has a master’s degree in Public Health with a concentration in Chronic Disease Epidemiology from Yale University. She earned a bachelor of arts in Natural Sciences (with a minor in Women's Studies) from Johns Hopkins University.

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