[Histonet] Clia grossing regulations

[joelle weaver]

The
minimum training/experience required of such personnel is:


 


1.                 
An earned associate degree in a laboratory
science or medical laboratory technology, obtained from an accredited
institution, OR


2.                 
Education/training equivalent to the above that
includes at least 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 6 semester hours of chemistry, 6
semester hours of biology, and 12 semester hours of chemistry, biology or
medical laboratory technology in any combination.  In addition, the individual must have
laboratory training including either completion of a clinical laboratory
training program approved or accredited by the ABHES, the CAHEA, or other
organization approved by HHS (note that this training may be included in the
60 semester hours listed above), OR at least 3 months documented laboratory
training in each specialty in which the individual performs high complexity
testing.


 


In addition, the
CLIA-88 regulations include exceptions for grandfathered individuals;
these regulations (42CFR493.1489 and 1491) may be found at http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1487


 





Joelle Weaver MAOM, HTL (ASCP) QIHC
 
> From: jclark <@t> pcnm.com
> To: histonet <@t> lists.utsouthwestern.edu
> Date: Thu, 21 Nov 2013 18:09:34 +0000
> Subject: [Histonet] Clia grossing regulations
> 
> Carol, here they are:
> 
> **REVISED** 07/11/2011
> 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: The laboratory director may delegate the dissection of specimens to non-pathologist
> individuals; these individuals must be qualified as high complexity testing personnel under CLIA
> regulations. The minimum training/experience required of such personnel is:
> 1. An earned associate degree in a laboratory science or medical laboratory technology,
> obtained from an accredited institution, OR
> 2. Education/training equivalent to the above that includes at least 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 6 semester hours of chemistry, 6 semester hours of biology, and
> 12 semester hours of chemistry, biology or medical laboratory technology in any
> combination. In addition, the individual must have 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 3 months documented
> 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 satisfies the requirements of this checklist requirement.
> This checklist requirement applies only to laboratories subject to US regulations.
> 
> Joanne Clark, HT
> Director of Histology
> Pathology Consultants of New Mexico
> --------------------------------------------------------------------------------------
> 
> Message: 4
> Date: Wed, 20 Nov 2013 21:22:47 -0500
> From: Carol Kowalcyk <ckowalcyk <@t> gmail.com>
> Subject: [Histonet] what are the Clia regulations for an Ht to
> 	gross??? 
> To: Histonet <@t> lists.utsouthwestern.edu
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