Here are the CAP Regulations:

ANP.11605 Gross Examination - Non-Pathologist Phase II



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.



NOTE: This protocol must list the specific types of specimens for which 
non-pathologists are permitted to assist in the gross examination. The nature 
of the supervision must be established individually, for each non-pathologist. 
The laboratory director is responsible for this protocol. For Mohs surgery a 
dermatologist is also qualified to perform the gross examination and to 
supervise non-pathologists.



REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid 
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed 
Register. 1992(Feb 28):7183 [42CFR493.1489(b)(7)]
2) Cibull ML. Q&A. Northfield, IL: College of American Pathologists CAP Today. 
1997;11(7):112
3) Grzybicki DM, et al. National practice characteristics and utilization of 
pathologists' assistants. Arch Pathol Lab Med. 2001;125:905-912



ANP.11610 Gross Examination Qualifications Phase II



If individuals other than a pathologist or pathology resident assist in gross 
examinations, such individuals qualify as high complexity testing personnel 
under CLIA regulations.


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, NAACLA, 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. It is the responsibility of the laboratory director to determine 
whether an individual's education,training and  experience satisfy the 
requirements of this checklist requirement. This checklist requirement applies 
only to laboratories subject to US regulations.



Evidence of Compliance:
✓ Records of qualifications including degree or transcript and work history in 
related field



REFERENCES
1) Department of Health and Human Services, Centers for Medicare and Medicaid 
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed 
Register. 2003(Oct 1):1070-1071 [42CFR493.1489], 1071-1072 [42CFR493.1491] 


ANP.11640 Competency Assessment of Non-Pathologists Phase II



The competency of non-pathologist(s) who assist in the performance of gross 
tissue examinations is assessed by the pathologist at least annually.



NOTE: Please refer to GEN.55500, Competency Assessment, in the Laboratory 
General checklist for a list of criteria and frequency for competency 
assessment. Not all six elements may apply in all cases. For Mohs surgery a 
dermatologist is also qualified to perform the gross examination and evaluate 
non-pathologists.



Evidence of Compliance:
✓ Written procedure and schedule for assessing competency of non-pathologists 
AND
✓ Records of competency assessment performed at a defined frequency



REFERENCES
1) Cibull ML. Q&A. Northfield, IL: College of American Pathologists CAP Today. 
1997;11(7):112
2) Grzybicki DM, et al. The usefulness of pathologists' assistants. Am J Clin 
Pathol. 1999;112:619-626
3) Galvis CO, et al. Pathologists' assistants practice. A measurement of 
performance. Am J Clin Pathol. 2001;116:816-822






Jason McGough, HT(ASCP)

Operations Manager

Clinical Laboratory of the Black Hills

605-343-2267

jmcgo...@clinlab.com <mailto:jmcgo...@clinlab.com> 

www.clinlab.com <http://www.clinlab.com> 

 
 
-----Original message-----
> From:Patti Nelson - PN Lab Consultant via Histonet 
> <histonet@lists.utsouthwestern.edu <mailto:histonet@lists.utsouthwestern.edu> 
> >
> Sent: Monday, January 8, 2018 3:58 PM
> To: Histonet@lists.utsouthwestern.edu 
> <mailto:Histonet@lists.utsouthwestern.edu> 
> Subject: [Histonet] GROSSING UNDER DIRECT SUPERVISION OF A PATHOLOGIST
> 
> Hello histoland,
> 
> 
> Can anyone direct me to any regulation that said a uncertified 
> Histotechnician can gross (small bx totally submitted) under direct 
> supervision.  Thank you in advance.
> 
> 
> Sincerely,
> 
> PATTI NELSON  H.T.(ASCP)
> SUPERVISOR DGC/ZADEH LABS
> PO BOX 412
> CABAZON, CA. 92230
> 909-841-9761
> nelsonr...@verizon.net <mailto:nelsonr...@verizon.net> 
> CONFIDENTIALITY NOTICE:This message and any included attachments are from 
> Patti Nelson, PNP Laboratory Consultants and are intended only for the 
> addressee. The information contained in this message is confidential and may 
> contain privileged, confidential, proprietary and/or exemption from 
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> distribution, or use of such information is strictly prohibited and may be 
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