[Histonet] What is considered Grossing according to CLIA and CAP? Definition?

Wed Mar 1 16:00:55 CST 2023

Per the grossing definition in ANP.11610 below, grossing is defined as a tissue examination requiring judgment and knowledge of anatomy. This includes the dissection of the specimen, selection of tissue, and any level of examination/description of the tissue including color, weight, measurement or other characteristics of the tissue. CLIA Regulation 42 CFR Part 493.1489 would apply for high complexity testing personnel qualifications.

CAP regulations:

ANP.11600 Gross Examination - Qualifications
All macroscopic tissue gross examinations are performed by a qualified pathologist or pathology resident, or another qualified physician (see note), or under the supervision of a qualified pathologist.

ANP.11605 Gross Examination - Non-Pathologist
When individuals other than a pathologist or pathology resident assist in gross examinations, the extent of their activities and the nature of supervision (direct vs. indirect) is defined in a written protocol.

ANP.11610 Gross Examination - High Complexity Testing Qualifications
If individuals other than a pathologist or pathology resident (or an individual who meets the grossing subspecialty qualifications listed under ANP.11600) assist in gross
examinations, such individuals qualify as high complexity testing personnel.

NOTE: Grossing is defined as a tissue examination requiring judgment and knowledge of anatomy. This includes the dissection of the specimen, selection of tissue, and any level
of examination/description of the tissue including color, weight, measurement or other characteristics of the tissue. 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.

Jennifer Wooten, BA, BS, HTL (ASCP)CM
Pronouns: she/her/hers
Technical Quality Assurance Auditor | Quality Systems | Tricore
Mobile: 505.440.0158
www.tricore.org

-----Original Message-----
From: Michelle Bell <mcokertx at gmail.com>
Sent: Monday, February 27, 2023 4:31 PM
To: Donna Emge <djemge11 at gmail.com>; histonet at lists.utsouthwestern.edu
Subject: Re: [Histonet] What is considered Grossing according to CLIA and CAP? Definition?

This is so hard to unpack everything that could be wrong with this situation.  The weights the lab assistants take would lead me to the conclusion that this would be part of grossing, because it is reportable.  It’s such a slippery slope when you start delegating tasks associated with high complexity testing.  If I were the manager, I would reach out to your accrediting agency for guidance and support.
________________________________
From: Donna Emge via Histonet <histonet at lists.utsouthwestern.edu>
Sent: Monday, February 27, 2023 9:39:08 AM
To: histonet at lists.utsouthwestern.edu <histonet at lists.utsouthwestern.edu>
Subject: [Histonet] What is considered Grossing according to CLIA and CAP? Definition?

I hope someone here can help. I recently visited a lab that has the lab assistants weigh placentas and document, cut the membrane off in one piece around the placenta, cut the umbilical cord off 1” from the placenta, then weigh again, document the weight again, and add the formalin for the PAs to gross the next day.  They consider what the lab assistants are doing as processing, not part of grossing. Is this correct? The PAs and Pathologists would like the lab assistants to do this at our lab.

   1. What is the CLIA and CAP actual definition of grossing? Where do I
   find this?
   2. Is what the lab assistants are doing at that lab actually a part of
   grossing, or are they just processing the placentas by the regulatory
   definition?

Thank you in advance,

*Donna Emge, HT (ASCP)*
UChicago Medicine | AdventHealth
GL Regional Laboratory Manager | Histology

Donna.Emge(@)AdventHealth.com
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