Professional component location

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DPath2000

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Hello, I have been an admirer of this forum for many years and I have a question.

Is there some sort of definition of what action constitutes the professional component - in reference to the location where it is performed? This is for histopathology.

I know that wasn't very clear so let me elaborate:

We have a histopathology lab with attached offices for pathologists to read and sign cases. We only bill globally. Most of the time the pathologists read (with the microscope) and sign the cases out at the lab.

Occasionally, a pathologist may read the cases at the lab and sign them out from home or one of our other offices (not CLIA certified). In this scenario is the PC done at the lab (where the slides were read) or at home (where the cases were signed)?

We sometimes have a situation where the pathologist may have the slides sent either to their home or one of our other (non CLIA certified) offices where it may be more temporarily convenient for them to read the work. These cases are then transmitted back to the lab for transcription and coding. The pathologists usually sign the cases out the next day or the next time they are back at the lab. In this case, is the PC taking place where the reading is performed or is it taking place back at the lab where the cases are signed?

The LIS system can only be accessed by VPN which involves a direct connection from the pathologist's computer to the lab.

I guess the question really is - is the PC performed where the cases is read under the microscope or where the cases is electronically signedout from?

The last follow up question is: We have an older pathologist who wants to read and sign work out Friday and Monday from his lake house (in an adjacent state). If we prepare the work at the lab and FedEx to the pathologist's home for him to read and sign, does the house need a CLIA certification? Can the cases still be billed globally? If the case was prepared in one state and read in another state does the pathologist need to be licensed in both states?


thanks!
 
There are clearly defined rules of this game. The majority of cases should be signed from the designated place. If it done otherwise due to logistic issues there are provisions and explanations depending on the size of the operation. Of course major issues like QA, licensing requirements, Who signs cases, etc are red flags to avoid.
 
There are clearly defined rules of this game. The majority of cases should be signed from the designated place. If it done otherwise due to logistic issues there are provisions and explanations depending on the size of the operation. Of course major issues like QA, licensing requirements, Who signs cases, etc are red flags to avoid.

Can you point us in the direction of these clearly defined rules? Our goal is to do this the right way.
 
Hello, I have been an admirer of this forum for many years and I have a question.

Is there some sort of definition of what action constitutes the professional component - in reference to the location where it is performed? This is for histopathology.

I know that wasn't very clear so let me elaborate:

We have a histopathology lab with attached offices for pathologists to read and sign cases. We only bill globally. Most of the time the pathologists read (with the microscope) and sign the cases out at the lab.

Occasionally, a pathologist may read the cases at the lab and sign them out from home or one of our other offices (not CLIA certified). In this scenario is the PC done at the lab (where the slides were read) or at home (where the cases were signed)?

We sometimes have a situation where the pathologist may have the slides sent either to their home or one of our other (non CLIA certified) offices where it may be more temporarily convenient for them to read the work. These cases are then transmitted back to the lab for transcription and coding. The pathologists usually sign the cases out the next day or the next time they are back at the lab. In this case, is the PC taking place where the reading is performed or is it taking place back at the lab where the cases are signed?

The LIS system can only be accessed by VPN which involves a direct connection from the pathologist's computer to the lab.

I guess the question really is - is the PC performed where the cases is read under the microscope or where the cases is electronically signedout from?

The last follow up question is: We have an older pathologist who wants to read and sign work out Friday and Monday from his lake house (in an adjacent state). If we prepare the work at the lab and FedEx to the pathologist's home for him to read and sign, does the house need a CLIA certification? Can the cases still be billed globally? If the case was prepared in one state and read in another state does the pathologist need to be licensed in both states?


thanks!
To bill out the site where slides are read needs to be CLIA certified. It gets more complicated if you are dividing the technical and professional component. Get a lawyer to walk you through Stark etc and CLIA requirements. Forum is not a great place to get this information. Also different states have different requirements..... get a lawyer.
 
To bill out the site where slides are read needs to be CLIA certified. It gets more complicated if you are dividing the technical and professional component. Get a lawyer to walk you through Stark etc and CLIA requirements. Forum is not a great place to get this information. Also different states have different requirements..... get a lawyer.

Thanks for your response, probably good advice. I was just really curious about the first question: what constitutes the PC - is it where you read the slide and make the diagnosis? Or sign the transcribed report? It seems like what you’re all saying is that no one really knows and both constitute the PC.

I wasn’t talking about telemedicine though I appreciate the similarity and the example. It seems like what people are saying is that even if you read the case at your lab, make the diagnosis, write the diagnosis and send it in to be typed (all in the lab)- if you wanted to sign it from your house in the same county, you would need to have a clia certification for your home where you sign the report.
 
Thanks for your response, probably good advice. I was just really curious about the first question: what constitutes the PC - is it where you read the slide and make the diagnosis? Or sign the transcribed report? It seems like what you’re all saying is that no one really knows and both constitute the PC.

I wasn’t talking about telemedicine though I appreciate the similarity and the example. It seems like what people are saying is that even if you read the case at your lab, make the diagnosis, write the diagnosis and send it in to be typed (all in the lab)- if you wanted to sign it from your house in the same county, you would need to have a clia certification for your home where you sign the report.
You have to read and interpret the slides at the site with the CLIA. The slides should remain at the site with the CLIA. Have no idea about digital slides or if you can interpret at a CLIA site then sign it out later as long as you did the interpretation at the site with CLIA and can prove that this is the case.... not sure if you can then sign out already interpreted slides in your cue off somewhere else. I know that the interpretation has to be done at a CLIA site
 
You have to go back to why we ended up with CLIA in the first place. There was a big scandal with paps. In some cases cytotechs were taking home 100s of pap slides to read.
There was essentially little over-site for these labs.
They made the rule that physical location were the diagnosis or test result is rendered needs to get a CLIA certificate. This is true of all lab tests.

That may change now that we have digital images. So far CLIA has not changed
 
Just get a CLIA certificate for your home office? That being said I have never known a situation where someone reviewed slides at home and government had a real problem with it.

Honestly to most bureaucrats it wouldnt be different than doing their work on a laptop at home in the evening, which they would read as a sign of dedication not attempting to skirt the rules.

I know pathologists who work themselves into a total fit over this and I can guarantee they dont really understand the laws in their locality that govern this.

This really isnt true: "You have to read and interpret the slides at the site with the CLIA. The slides should remain at the site with the CLIA."

I would try not to give legal advice on SDN and more importantly dont give incorrect legal advice. I have done this in the past here sparingly and only when I have expert legal opinion to back up my own reading of the actual law.
 
Well maybe I break the law occasionally. I do a small amount of pod lab dermpath every few weeks and often I dictate in the cases on site but then sign them out back in my office later, as the transcription isn't done when I'm done reviewing the cases at the derm office. I always figured because I was reading the cases on site I was following the letter of the law. But maybe by physically signing them out over the internet back at my office I'm not. (shrugs)
 
Well maybe I break the law occasionally. I do a small amount of pod lab dermpath every few weeks and often I dictate in the cases on site but then sign them out back in my office later, as the transcription isn't done when I'm done reviewing the cases at the derm office. I always figured because I was reading the cases on site I was following the letter of the law. But maybe by physically signing them out over the internet back at my office I'm not. (shrugs)

You are not "breaking the law"...DO NOT listen to pathologists of all people about the law, you can get better quality legal advice from a churro stand at a soccer game in Fresno.

This is actually WORSE than someone throwing out faux medical advice on SDN, dont do it. Just dont.
 
It is a public forum and every situation has different details. I used to take cases home every Tuesday so I could tee off at 11.30 a.m on Wednesday. If someone comes asking, I can explain!
 
The legal advice I worked under allowed me to electronically
“sign/release” my cases from anywhere. The location
of my scope had to have a CLIA cert. Neither I nor the many,
pathologists I’ve worked with ever had a problem with
this system.

Do y’all have to have a DEA cert for those of you with medical
staff privileges? Now THAT is stupid (with limited exceptions).
 
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