Question about PAs

[pathstudent]

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Are there legal or CAP or CLIA requirements to be able to gross specimens? I met someone who told me she was originally a histotech that was trained on the job to gross and never studied for it. Is that kosher?

 

[KCShaw]

http://forums.studentdoctor.net/showthread.php?t=716292

I also started looking at the CLIA regulations on the CDC website, but got very tired very quickly of the font and poor writing style. From what I gather from briefly scanning it, and some other website comments, one needs to be qualified to perform high-complexity testing (with defined education requirements) in order to gross any specimen which isn't submitted in toto (basically, just biopsies), but there are some clauses to grandfather in people who got started back in the early to mid 90's and apparently some clause that the decision is ultimately up to the laboratory director.

 

[Pingu]

The 2010 CAP Checklist that was released in June made some drastic changes with regard to grossing.

From CAP:

In preparation for the release of the 2010 CAP Checklist Edition in June of this year, CAP is notifying all accredited anatomic pathology laboratories of a revised checklist requirement that may have an impact on your laboratory’s staffing.

The revisions will require that all non-pathologist individuals who perform macroscopic tissue examinations meet the personnel requirements for high complexity testing in accordance with CLIA. This interpretation of the CLIA requirement was recently provided to CAP from CMS. As a service to CAP Accredited laboratories, the CAP offers compliance alerts to help your laboratory maintain continuous compliance.

Previously, the Anatomic Pathology checklist differentiated two levels of macroscopic examination, “processing” and “grossing.” In this context, “processing” means macroscopic examination of small specimens not requiring knowledge of anatomy, which are entirely submitted for microscopic examination, while “grossing” means macroscopic examination of more complex specimens. Unlike individuals who performed grossing, individuals who performed “processing” were not required to be qualified as high complexity testing personnel. In the 2010 checklist edition, the concept of macroscopic tissue “processing” will no longer be recognized. All macroscopic tissue examinations will be considered to be “grossing.”

Therefore, any individual who performs macroscopic tissue examinations must be a pathologist, pathology resident, or an individual qualified to perform high complexity testing under the supervision of a pathologist (refer to ANP.11610).

In a nutshell, if you are CAP accredited, you have to be qualified to perform high complexity testing to do any form of grossing, including entirely submitted specimens (GIs, etc).

CLIA requirements for high complexity testing are fairly stringent with regard to education and experience. Grandfathering applies in a number of ways, but essentially you have to have a HS diploma and have been trained prior to September 1st, 1997. Even then, if you weren't performing high complexity testing before 1993, you have to work under the direct supervision of a general supervisor.

So while CLIA currently makes exceptions, there will be a time in the future where grandfathering won't apply because of age. CAP has made this a Phase II deficiency.

CAP also states "It is the responsibility of the laboratory director to determine whether an individual’s education, training and experience satisfies the requirements of this checklist question."

I don't think this statement gives the leeway people think it does, because you have to meet CLIA requirements no matter what. My interpretation is CAP is placing the burden of verifying employee qualifications on the lab director.

 

[pathstudent]

The 2010 CAP Checklist that was released in June made some drastic changes with regard to grossing.

From CAP:

In preparation for the release of the 2010 CAP Checklist Edition in June of this year, CAP is notifying all accredited anatomic pathology laboratories of a revised checklist requirement that may have an impact on your laboratory’s staffing.

The revisions will require that all non-pathologist individuals who perform macroscopic tissue examinations meet the personnel requirements for high complexity testing in accordance with CLIA. This interpretation of the CLIA requirement was recently provided to CAP from CMS. As a service to CAP Accredited laboratories, the CAP offers compliance alerts to help your laboratory maintain continuous compliance.

Previously, the Anatomic Pathology checklist differentiated two levels of macroscopic examination, “processing” and “grossing.” In this context, “processing” means macroscopic examination of small specimens not requiring knowledge of anatomy, which are entirely submitted for microscopic examination, while “grossing” means macroscopic examination of more complex specimens. Unlike individuals who performed grossing, individuals who performed “processing” were not required to be qualified as high complexity testing personnel. In the 2010 checklist edition, the concept of macroscopic tissue “processing” will no longer be recognized. All macroscopic tissue examinations will be considered to be “grossing.”

Therefore, any individual who performs macroscopic tissue examinations must be a pathologist, pathology resident, or an individual qualified to perform high complexity testing under the supervision of a pathologist (refer to ANP.11610).

In a nutshell, if you are CAP accredited, you have to be qualified to perform high complexity testing to do any form of grossing, including entirely submitted specimens (GIs, etc).

CLIA requirements for high complexity testing are fairly stringent with regard to education and experience. Grandfathering applies in a number of ways, but essentially you have to have a HS diploma and have been trained prior to September 1st, 1997. Even then, if you weren't performing high complexity testing before 1993, you have to work under the direct supervision of a general supervisor.

So while CLIA currently makes exceptions, there will be a time in the future where grandfathering won't apply because of age. CAP has made this a Phase II deficiency.

CAP also states "It is the responsibility of the laboratory director to determine whether an individual’s education, training and experience satisfies the requirements of this checklist question."

I don't think this statement gives the leeway people think it does, because you have to meet CLIA requirements no matter what. My interpretation is CAP is placing the burden of verifying employee qualifications on the lab director.

hmmmmm....this makes it seem likely to affect gi path labs and GU path labs. Surely they are just paying some guy off the street minimum wage to accession the specimens, cassette them and load the machine. But I don't imagine those labs get CAP inspected. Hopefully CLIA will enforce these regulations.

 

[zao275]

So what about the histotechs who embed biopsies? I assume they don't have to have higher levels of education to be able to do this. To me, it seems that grossing a biopsy and embedding one are on a pretty similar level of complexity. Large complex specimens are an entirely different story, of course.

 

[KCShaw]

Makes one at least wonder if this is related to the higher TC component -- if yer gonna get paid for it, better have to dump more salary onto someone with a certificate to do it. Maybe that's just my suspicious side.

There's little reason any reliable schmoe who can count, has decent eyesight/glasses, and speaka the adequate Engrish can't repeat "..received in formalin in a container labeled with the patient's name and case number are X tan brown soft tissues ranging in size from 0.2 cm to 0.4 cm, and are submitted entirely in Y cassettes.." or similar 100 times a day. Particularly if they're also allowed to pull the same biopsy material back out, poke it around a bit, and embed it. Frankly, embedding is more "technically" difficult, particularly with a bunch of tiny fragments that want to float. (Of course, I say all this assuming histotechs are still only required to handle moderate complexity tasks/testing such as "processing" -- I do see a bunch of histo titled jobs advertised for moderate and high complexity testing though.)