[Histonet] GROSSING UNDER DIRECT SUPERVISION OF A PATHOLOGIST

Mon Jan 8 17:11:11 CST 2018

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

jmcgough at clinlab.com <mailto:jmcgough at clinlab.com> 

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

-----Original message-----
> From:Patti Nelson - PN Lab Consultant via Histonet <histonet at lists.utsouthwestern.edu <mailto:histonet at lists.utsouthwestern.edu> >
> Sent: Monday, January 8, 2018 3:58 PM
> To: Histonet at lists.utsouthwestern.edu <mailto:Histonet at 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
> nelsonrnch at verizon.net <mailto:nelsonrnch at 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 disclosure under applicable law.  Unauthorized forwarding, printing, copying, distribution, or use of such information is strictly prohibited and may be unlawful.  If you are not the addressee, please promptly delete this message and notify the sender ofthe delivery error by e-mail or you may call  909-841-9761.
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