Do I need a CLIA to read AP slides at home?

[ElementMD]

I have an opportunity to work reading GI slides for a local GI practice.

I understand I will read most slides in the GI office (nights and weekends) but also I will read some at my personal scope at home.

Do I need a CLIA certificate to cover my home office/lab?

Thank you

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[caffeinegirl]

Status of remote pathologist interpretations after PHE: Does it affect your current workflows?

Pathology groups, other physician specialty groups, and laboratories that are involved in performing remote services in any capacity should take time to review all applicable regulations to determine if the delivery of remote services remains compliant in the post-PHE regulatory landscape.

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[Dave CX]

In my opinion you do.

 

[Alteran]

Yes you do. But the situation is all topsy turvy.

If you want to sign out cases remotely through the use of digital pathology, that is allowed. The government has absolutely zero issue with pathologists signing out cases on monitors of questionable quality. If you have a 1990s CRT monitor that your kid rubbed a magnet all over and have more than 10% dead pixels but want to use it to sign out cases remotely, that's A O.K. according to the government - no oversight needed there 👍

However, the government feels that if you have a clinical grade microscope at home, you are trying to have a lab with components that would be associated with a lab and therefore need a CLIA license. Never mind that a good chunk of CLIA certified labs equip their pathologists with microscopes from the Byzantine era which are of suspect optical quality, as long as some biomed engineer comes by and slaps a sticker on it its all kosher.

The good news, if there is any, is that getting a CLIA license is a low bar to clear. You will of course have to put the CLIA number and address on your reports as the site of service, so if you don't want people knowing where you live, I wouldn't work from home.

 

[Med Director New England]

it’s very hard, if not impossible, to tell where you actually did the work. Esp for the web based EMRs typical of in office skin/GU/GI gig (like VitalAxis)

Oops did I say that out loud

 

[ElementMD]

Yes you do. But the situation is all topsy turvy.

If you want to sign out cases remotely through the use of digital pathology, that is allowed. The government has absolutely zero issue with pathologists signing out cases on monitors of questionable quality. If you have a 1990s CRT monitor that your kid rubbed a magnet all over and have more than 10% dead pixels but want to use it to sign out cases remotely, that's A O.K. according to the government - no oversight needed there 👍

However, the government feels that if you have a clinical grade microscope at home, you are trying to have a lab with components that would be associated with a lab and therefore need a CLIA license. Never mind that a good chunk of CLIA certified labs equip their pathologists with microscopes from the Byzantine era which are of suspect optical quality, as long as some biomed engineer comes by and slaps a sticker on it its all kosher.

The good news, if there is any, is that getting a CLIA license is a low bar to clear. You will of course have to put the CLIA number and address on your reports as the site of service, so if you don't want people knowing where you live, I wouldn't work from home.

Thank you

 

[coroner]

This is an answer with shades of grey because not everything is black & white depending on the circumstances. I've never applied for a home CLIA license, so I'm strictly speaking from anecdotal evidence. There are multiple factors involved like quantity/frequency what state you're in and what governing bodies accredits your lab and their potential depth of inquiry.

If you have a microscope at home and you take a few extra slides home, it's usually a don't ask/don't tell situation between you and your lab i.e. if you were inspected/audited by CMS, DOH, JCAHO, etc. you could theoretically get penalized, but as long as the lab/administrators where the slides originate from doesn't squeal on you, nothing will happen. And, as the previous poster said, it's very hard to prove where you actually did the work. I personally know of pathologists who have done this, but it is a fraction of their work i.e. they don't just stay at home all day and a courier delivers a whole weeks' worth of trays to their home address.

If you wanted to push it and work multiple days or a week from home and you were not present at the lab at all, then a CLIA license would be a safe bet...YMMV. But as another prior poster mentioned, it's a low bar to clear to get one.

 

[ElementMD]

it’s very hard, if not impossible, to tell where you actually did the work. Esp for the web based EMRs typical of in office skin/GU/GI gig (like VitalAxis)

Oops did I say that out loud

I will be using a similar if not same EMR (Vital Axis). Seems like if it came down to it, it would be easy to tell where the case was signed out based on IP address or some other location tracking metadata within Vital Axis.

 

[Guest8]

I will be using a similar if not same EMR (Vital Axis). Seems like if it came down to it, it would be easy to tell where the case was signed out based on IP address or some other location tracking metadata within Vital Axis.

Yes, I would think that it would be very easy in today's world for them to digitally know where you are signing out cases. There's no real pretending you're physically somewhere else in the digital world, even with VPNs. I doubt secure hospital software would allow you to VPN a fake IP address.

 

[Med Director New England]

I will be using a similar if not same EMR (Vital Axis). Seems like if it came down to it, it would be easy to tell where the case was signed out based on IP address or some other location tracking metadata within Vital Axis.

A lot of wiggle room for the pathologist here

Who’s realistically going to dig so hard to try and find the IP address of the computer you were at when you hit release on the case ? It would take a pretty savy forensic audit of the EMR.

plausible also to do all the work at actual clia site
& log on and release it later.

 

[imanurse]

Also might VPN to RDP or other virtual desktop so ip inside would be the same for everyone