By Jed Morrison
In light of the shortage of COVID-19 laboratory testing services, and the overall pressures on the healthcare industry created by responding to the crisis, the Centers for Medicare & Medicaid Services (CMS) have issued temporary instructions regarding laboratory testing services, which are governed by the Clinical Laboratory Improvement Amendments (CLIA). In addition to minor laboratory operational procedures, the CMS notice made the following significant changes, to help ensure wider availability of COVID-19 laboratory testing.
Remote Slide Review
CLIA regulations for cytology testing (tissue) state that cytology slide preparations must be evaluated on the premises of a laboratory certified to conduct testing in the subspecialty of cytology (42 C.F.R. 493.1274(a). In other words, both the slide preparation and the professional analysis must occur on the lab premises. Thus, for hospital based laboratories, unless the pathologist has a separate CLIA certificate in her home, the pathologist must review the slides on the hospital lab premises.
As it has done in previous public health emergencies, CMS is exercising its enforcement discretion and will not enforce the requirement to have a separate CLIA certificate for laboratories that are located at a temporary testing site, provided that the designated primary site or home base has such a certificate (using the address of the primary site) and the work being performed in the temporary testing site falls within the parameters of the primary site’s certificate. A temporary testing site is one where, at various intervals of time, an entity that is not at a fixed or permanent location performs laboratory testing. Such a temporary testing site may be the pathologist’s home.
Expedited Review of New CLIA Applications
Laboratories need a CLIA certificate to perform any services, including COVID-19 testing. Thus, any person that wishes to operate a laboratory must apply for a CLIA certificate. The temporary CMS policy doesn’t waive any CLIA requirements, but it does state that once the laboratory has identified a qualified laboratory director and has provided all required information on the CLIA application, a CLIA number will immediately be assigned. The new lab may conduct testing once a CLIA number has been assigned, as opposed to waiting for a hard copy paper certificate to come in the mail.
Ordinarily, each separate laboratory location must have its own CLIA certificate. Under the new policy, Laboratories within a hospital/University Hospital Campus that are located at contiguous buildings on the same campus and under common direction (meaning that all testing sites are under one designated director) may hold a single certificate for the laboratory sites within the same physical location or street address. This policy will be useful for large hospitals and academic medical centers wishing to temporarily expand laboratory services.
Edgar “Jed” C. Morrison, Jr. has practiced healthcare law for almost 40 years and is one of the founding members of Jackson Walker’s Healthcare section. With a board certification in Health Law by the Texas Board of Legal Specialization, Jed exclusively represents healthcare providers and other industry participants related to the regulatory and transactional aspects of healthcare law. In recognition of his practice, Jed has been named among Chambers USA for Healthcare in Texas since 2006, among The Best Lawyers in America for Healthcare Law since 2007, as a “Super Lawyer” by Thomson Reuters (2007-2016, 2018-2019), and as a “Best S.A. Lawyer” in the Healthcare area by San Antonio Scene since 2010.
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