CMS/CLIA Allowing Temporary Remote Signout During COVID-19 Pandemic (Regulatory Flexibilities)
Prior and original outline (April 2020):
CMS/CLIA Allowing Temporary Remote Signout During COVID-19 Pandemic
Organized by the Alliance Practical Use Cases Working Group
Lead: Joe Sirintrapun (MSKCC), Joe Lennerz (MGH), Matthew Hanna (MSKCC), Richard Huang (MGH)
The group is working to clarify the regulatory framework currently prohibiting remote/digital signout. After the emergency declaration by President Trump (3/13/2020) several strategies have been identified to enable more telemedicine and telepathology solutions. The group aims to provide a repository of related information.
Many members of the Alliance helped draft multiple pathology society letters to engage CMS to temporarily relax CLIA regulations to enable pathologist to signout remotely.
Pathology remote signout during this pandemic is needed to both continue providing high quality patient care during the COVID-19 pandemic where social distancing and remote-work-from-home is highly encourage to contain the spread of the infection, but also to protect the majority of the pathologist workforce many of whom are at an age that make them more susceptible to the infection. You can find below a list of letters sent to CMS. If any member of the Alliance contributed to drafting other letters not listed here, please e-mail the Alliance with a link to the letter and we will add it to the list below.
CMS exercises enforcement discretion to ensure pathologists may review pathology slides remotely if certain defined conditions are met during COVID-19 public health emergency
On March 26, 2020, CMS released Memo #QSO-20-21-CLIA, titled “CMS Clinical Laboratory Improvement Amendments (CLIA) Laboratory Guidance During COVID-19 Public Health Emergency”.
Link: https://www.cms.gov/files/document/qso-20-21-clia.pdf-0
Details of the enforcement discretion related to remote signout can be found under “Remote Review of Clinical Laboratory Data, Results and Pathology Slides”.
Part 1: The Alliance’s analysis of the details of CMS’ memorandum temporarily allowing remote signout
There is some confusion interpreting CMS’ memorandum, especially with regards the need for a separate CMS Form 116/CLIA certificate for the remote site (eg. the pathologist’s home). Dr. Richard Huang has given his analysis below, which helps clarify the meaning of the memorandum.
From Dr. Richard Huang:
My high level summary of the CLIA Memorandum from today:
The primary site is a regular CLIA certified lab.
The primary site already has established digital pathology signout, as in it has a written procedure manual for this.
The remote temporary site can be the pathologist’s home.
The remote site, as long as it is temporary, can do the same procedure that is established at the primary site, in this case digital pathology signout, without the need for a separate CLIA certificate at the remote site.
So if an institution/primary site lab already has a established on-site digital pathology signout setup in place, then that primary site can have remote temporary sites (i.e. a pathologist’s home) perform the same procedure (i.e. digital pathology signout), without the need for the remote temporary site to file for a separate CMS Form 116 to obtain its own CLIA certificate.
The details…
From the Memorandum: https://www.cms.gov/files/document/qso-20-21-clia.pdf-0
“...as we have done in previous public health emergencies, we are exercising our enforcement discretion and we will not enforce the requirement to have a separate 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. (§493.35(b)(1). 43(b)(1), 55(b)(1)) A temporary testing site is 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.”
“Laboratories that choose to utilize temporary testing sites (e.g., for remote review and reporting of slides/images), may do so if the following criteria are met:
The temporary site complies with other applicable Federal law, including HIPAA.
As per §493.1251 The 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.”
My reading here is that the “Laboratories” refers to the primary site, so as long as the primary site is CLIA certified, then the temporary site (eg. pathologist’s home) should be able to perform the same procedures established at the primary site without the need for a separate CMS Form 116/CLIA certificate for the temporary site.
Also, the CLIA State Operations Manual specifically talks about Temporary Testing Sites: https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107c06.pdf
6010.1 - Mobile Laboratory Units and Temporary Testing Sites
(Rev. 199, Issued: 01-17-20, Effective: 01-17-20, Implementation: 01-17-20)
Exception (b)(1): Laboratories that are not at a fixed location, that is, laboratories that move from testing site to testing site, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations may be covered under the CLIA certificate and address of the designated primary site or home base. (42 CFR 493.35(b)(1), 493.43(b)(1), or 493.55(b)(1)).
This makes it pretty clear that temporary testing locations (in this case the pathologist’s home), can be covered under the primary site’s CLIA certificate.
Part 2: The Alliance’s analysis of the details of CMS’ memorandum temporarily allowing remote signout
Some additional questions were asked by the pathologist community about CMS’ memorandum, especially with regards to the need of having a “written procedure manual” for digital pathology in place as a precondition to being able to do remote signout.
One comment, from Dr. JP, was very insightful in illustrating this: “I thought the whole point of this emergent process [with regards to CMS temporarily allowing remote signout] was that those…using digital path, but not in normal terms for primary signout, could use this system for remote (home) primary signout. Thus how would we have a written procedure in place? Only few places like OSU and others that have FDA [authorized] scanners in place would have written procedures in place for DP signout, no?”
Dr. Richard Huang has given his additional analysis below.
From Dr. Richard Huang:
If there is an established procedure (i.e. written procedure manual) at the primary site, then the temporary site can perform the same procedure without needing a separate CLIA certificate to cover the temporary site.
Here is an example:
Cytology Diff Quik staining is established at the primary site (i.e. there is a written procedure manual for this) that has a CLIA certificate.
When a pathologist puts the Diff Quik jars on a cart and rolls it across the street to an outpatient clinic where FNAs are performed, and the pathologist does the same Diff Quik staining procedure as established at the primary site, the pathologist is now performing a primary-site-established procedure at a temporary/remote site. The temporary/remote site is covered by the primary site’s CLIA certificate. CLIA allows this so that the Diff Quik cart/FNA clinic does not need its own CLIA certificate.
Prior to the Memorandum today, even if a CLIA certified lab has an established (i.e. written procedure manual) digital pathology system for primary diagnosis, pathologists can only signout cases using that digital system at the same primary site as where that CLIA certificate is held. The pathologist cannot go off-site (eg. home) to signout digitally even if the primary site has an established digital pathology system, without having to first request a separate CLIA certificate for the off-site location. In fact, the Memorandum explicitly states “It is important to note that this guidance does not apply to pathologists who have already obtained CLIA certificates for their home or other sites separate from the primary testing site.” This means that there are pathologists who did go through the trouble of getting a separate CLIA certificate for their homes so they could signout at home.
What the Memorandum did today was to allow pathologists to signout at home, with the assumption that the home is a temporary site because the public health national emergency due to the pandemic is only going to be temporary. This is only allowed if the primary site has an established digital pathology system, since you would simply be doing a procedure established at a primary site at a temporary off-site location. Just like the Diff Quik example above.
Answer to the question above “how would we have a written procedure in place?”
If a pathology lab did not make the initial investment of establishing an on-site (i.e. at the primary site) digital pathology signout system, then they definitely would not have a written procedure in place.
If a pathology lab wants to take advantage of the reprieve that CLIA gave us with remote sign out, then that lab needs to start developing an on-site digital pathology signout system right away. Once the on-site digital pathology signout system is established (i.e. written procedure manual in place), then pathologists can start doing remote signout using the same digital pathology system.
Answer to the question above “Only few places like OSU and others that have FDA [authorized] scanners in place would have written procedures in place for DP signout, no?”
Yes, it may be true that only a few labs/institutions have an established on-site (i.e. primary site) digital pathology system for signout. However, there is no regulation at all saying that on-site digital pathology primary sign out has to be done with FDA authorized scanners/systems. That is a limitation that pathologists/lab directors/institutions put on themselves. There are private labs that use internally validated/established digital pathology systems that are not FDA authorized for their primary signout, and they have absolutely no problems. Those lab directors decided to bear the burden of being bold and innovative, and they get to reap the rewards.
Remember, digital pathology is not mentioned at all in CLIA. Therefore, digital pathology specifically is not explicitly regulated by CLIA. The only reason that we wanted this CLIA enforcement discretion is because we did not want to have to get a separate CLIA certificate for reach of the remote sites (i.e. pathologists’ homes), not because CLIA does not allow us to use digital pathology. In fact, the Memorandum does not even use the word “digital” at all. The Memorandum only talks about “remote review and reporting of slides/images”.
We waited so long and fought so hard to get CLIA “let us” do digital pathology, but we never actually needed CLIA’s permission at all. CAP guideline for digital pathology outlines pretty clearly what they consider to be an established digital pathology system for clinical diagnostic purposes (https://webapps.cap.org/apps/docs/membership/wsi_validation_summary.pdf). The guideline was published in 2013. Any pathology lab/institution could have established an on-site digital pathology system for primary sign out since then. People did not do that for various reasons. CLIA holding pathologists back is not one of those reasons.
Fortune favors the prepared. For those institutions that invested early into establishing an on-site digital pathology signout system now gets to reap all the rewards of their proactive decisions. Their pathologists can fully take advantage of CLIA’s enforcement discretion and start signing out remotely from home. For those institutions that did not make that early investment into establishing an on-site digital pathology signout system, they are now spending precious time of the temporary reprieve trying to build out such a system. By the time that the validation is completed, it is possible that the national emergency would be over and the temporary reprieve would be gone. The bright side is we would now have more labs/institutions with on-site digital pathology signout systems, even if the primary diagnosis has to be done only at the primary site and not remotely at home.
How to validate digital pathology to enable remote signout
Now that CMS is temporarily allowing pathologists to signout remotely without the need for additional site licenses, many pathology labs are trying to validate their digital pathology systems for primary diagnosis on-site, with the understanding that once validated the digital pathology system can be used at a temporary off-site location (i.e. pathologist’s home) for primary signout. There are many ways to validate your digital pathology system, and ultimately it is at the discretion of the lab’s medical director to decide what is the best way to accomplish this. However, CMS’s Memo provided some guidance on what validation standard could be used.
From CMS’s Memo QSO-20-21-CLIA: “Laboratories that are accredited must follow their accrediting organization (AO) requirements and must follow applicable State laws, which may be more stringent than the CLIA requirements.”
For example, if a lab is CAP accredited, they can follow CAP’s Validating Whole Slide Imaging (WSI) for Diagnostic Purposes in Pathology Guideline: https://webapps.cap.org/apps/docs/membership/wsi_validation_summary.pdf
If a lab is not CAP accredited, they can still follow CAP’s guideline as a starting point to develop their own internal validation process to ultimately produce the “written procedure manual” needed as stated in the CMS Memorandum.