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March 30, 2020

CMS Guidance for Laboratories During COVID-19 : Remote Review of Laboratory Data, Results, and Slides/Images

The Centers for Medicare and Medicaid Services has issued Guidance for Laboratories during the current public health emergency. This guidance includes CMS exercising its enforcement discretion with regard to remote review of laboratory data, results, and slides.  

For purposes of the current COVID-19 public health emergency, CMS is exercising enforcement discretion in order to allow pathologists to review pathology slides remotely. For example, cytology slide preparations are generally required to be evaluated on a certified laboratory premises that is certified specifically in the subspecialty of cytology. CMS however is exercising its enforcement discretion with regard to the requirements to have separate certificates for laboratories located at temporary testing sites. This requirement will not be enforced during the public health emergency and it will only be required that the primary site or home base of such laboratory has a certificate and the testing that the temporary site is conducting falls within the scope of the primary sites’ certificate. CMS also provides specific criteria that must be met in order for a laboratory to utilize a temporary testing site for remote review and reporting.

Such criteria for the utilization of temporary testing sites for remote review and reporting of slides/images includes having

[a] current, unrevoked, or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation issued by HHS applicable to the category of examinations or procedures performed by the laboratory; or

per the regulations at 42 CFR § 493.1105(a)(7)…Cytology slide preparations must be retained for at least 5 years from the date of examination; Histopathology slides must be retained for at least 10 years from the date of examination; Pathology specimen blocks must be retained for at least 2 years from the date of examination; and Remnants of tissue for pathology examination must be preserved until a diagnosis is made on the specimen.

[e]quipment, supplies, and reagents, and other similar items needed at the temporary site are not kept at the temporary site on a permanent basis,

[t]he temporary site complies with other applicable Federal law, including HIPAA, and  

[a]s per § 493.1251 [t]he primary site must have a written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory’s written procedures for testing or examining specimens. The Laboratory Director is not required to send but CMS may ask to inspect it in the future.   

https://www.cms.gov/files/document/qso-20-21-clia.pdf-0

CMS also notes that such guidance will not apply to pathologists who already have CLIA certificates for their homes or other testing sites.

For more information you can contact Danielle Holley Tangorre or Samantha Femia at 518-462-5601 or dtangorre@oalaw.com or sfemia@oalaw.com. You can also refer to the guidance which  can be found at https://www.cms.gov/files/document/qso-20-21-clia.pdf-0