Re: [Histonet] California Grossing Requirements

From:Dave Low


This is the new requirement for the APR 2005 CAP#:
ANP.11610             Phase II	N/A   YES   NO

If specimens are dissected by individuals other than a
pathologist or pathology resident, do such individuals
qualify as high complexity testing personnel under
CLIA-88 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-88
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, 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

This checklist question applies only to laboratories
subject to CLIA-88. 

D. Low

--- Cindy DuBois  wrote:
> The person in our lab who grosses most of the
> surgical specimens is not a certified pathology
> assistant (or an HT).  At our last CLIA inspection
> the inspector asked us for the "PA's" certification
> documentation.  I deferred the question to the "PA"
> themselves.  She managed to change the subject quite
> quickly and the topic was not brought up again.  Now
> our grossing person is thinking that she is not
> qualified and should not be grossing according to
> government regulations.  I have not been able to
> find anything anywhere (google search) stating who
> can gross or not gross tissue specimens. 
> Can anyone help me with this question?
> Cindy DuBois
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