Hi,
Grossing is considered by CLIA a high complexity test therefore the testing
personnel must be in compliance with the requirements to perform the test, in
this case grossing . It doesn't matter what kind of tissue.
Reference CLIA
(a)(6) Specimen processing.
Interpretive Guidelines §493.1242(a)(6)
Specimen processing may include receiving the specimen, accessioning the
specimen, preparing the specimen for in-house analysis, preparation to send to
a reference laboratory, preparing slides, and inoculating primary culture
media, etc. Specimen processing also includes: Parasitology: the fixation and
concentration of specimens; Virology: the pretreatment of specimens with
antibiotics, the manipulation of cell culture tubes and inoculation of the cell
cultures prior to incubation; Mycobacteriology: performing
digestion-decontamination and concentration procedures on clinical specimens;
and Histopathology: specimen accession with or without fixation, embedding the
paraffin block, cutting the paraffin block, mounting the embedded cut tissue to
a slide, preparing the slide for staining, staining and cover slipping the
slide, or any other slide preparation procedures that do not involve
examination resulting in diagnostic interpretation.
Note: for histopathology specimens, specimen processing does not constitute a
CLIA test. Only gross examinations (including weighing, measuring, describing
color, specific orientation for diagnostic interpretation, and other
characteristics of the tissue, or performing other mechanical procedures
including dissection, inking, and marking) require a CLIA certificate.
Microscopic examinations of tissue with diagnostic interpretation and reporting
is a Histopathology test and requires CLIA certification.
Personnel:
The laboratory director may delegate the dissection of specimens to
non-pathologist individuals; these individuals must be qualified as high
complexity testing personnel under the CLIA regulations. The minimum
training/experience required of such personnel is:
1. An earned associate degree in a chemical or biological science or
medical laboratory technology, obtained from an accredited institution, OR
2. Education/training equivalent to the above that includes the following:
● 60 semester hours or equivalent from an accredited institution.
This education must include 24 semester hours of medical laboratory technology
courses, OR 24 semester hours of science courses that includes six semester
hours of chemistry, six semester hours of biology, and 12 semester hours of
chemistry, biology or medical laboratory technology in any combination, AND
● Laboratory training including either completion of a clinical
laboratory training program approved or accredited by the ABHES, NAACLS, or
other organization approved by HHS (note that this training may be included in
the 60 semester hours listed above), OR at least three months of recorded
laboratory training in each specialty in which the individual performs high
complexity testing.
Thanks,
Johanna Haddock
QA Manager
-----Original Message-----
From: Terri Braud via Histonet <[email protected]>
Sent: Monday, May 11, 2020 6:57 AM
To: '[email protected]' <[email protected]>
Subject: Re: [Histonet] grossing regulations
[EXTERNAL]
Actually, there is another route for some of us older techs. You can be
grandfathered in without a degree if you have a certain prerequisite number of
hours in specific science courses and prior documented training in grossing.
Of course, I'm so old, I don't remember the details. LOL
Terri L. Braud, HT(ASCP)
Anatomic Pathology Supervisor
Laboratory
Holy Redeemer Hospital
1648 Huntingdon Pike
Meadowbrook, PA 19046
ph: 215-938-3689
fax: 215-938-3874
Care, Comfort, and Heal
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1. Re: Grossing regulations (Mark Pawlowski)
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Message: 1
Date: Fri, 8 May 2020 17:17:14 +0000
From: Mark Pawlowski <[email protected]>
To: "[email protected]"
<[email protected]>
Subject: Re: [Histonet] Grossing regulations
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Hello Kristy,
The regulation say that you must have at least an Associates degree with a
certain amount of credits in the sciences. And yes, it is considered high
complexity.
Sorry I don?t remember the amount of credits.
Mark
> On May 8, 2020, at 1:00 PM, "[email protected]"
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> 1. Regulation for grossing derms (Kristy Castillo)
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> Message: 1
> Date: Fri, 8 May 2020 05:41:23 -0700
> From: Kristy Castillo <[email protected]>
> To: [email protected]
> Subject: [Histonet] Regulation for grossing derms
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> My question is: What would be the regulation (CLIA) to gross
> dermatology specimens? Are they not considered high complexity? Also, don't
> you have
> to have a HT to do this? Someone is telling me they can gross as long as
> they have associates. Is that correct? Sorry, I am a little confused
> with this. Thankful for all who answer this question.
>
> Kristy
> AZDermgroup, Histology Lab
>
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