[Histonet] A Question about CLIA Regs and Grossing in private Dermpath Labs

From:"Mickie Johnson"

Dear Histonetters,


I have a question to pose out there to all the private histology labs, but
particularly the dermpath labs. CLIA deems 'grossing' to be high complexity
testing. This has been discussed in the histonet before at length as
recently as 2007. Out of that discussion there was mention of the
requirement of 60 credits of education plus 3 months training. The following
relates to an interpretive guideline published in 2003. The following is
extracted from a histonet archive in March of 2006.


“www.cms.hhs.gov/clia is the link to the CLIA '88 information. See the new
federal register CLIA interpretive guidelines appendix C subpart M that are
effective April 24, 2003. The guidelines are available at
www.cms.hhs.gov/CLIA/downloads/apcsubm.pdf under qualifications of high
complexity testing personnel section 493.1489 (b)(7) it is clear that all
tissue gross examination whether it is color, measurement, or advanced
dissection is considered high complexity testing and individuals performing
this type of testing must qualify under this section. That is why the new
CAP question ANP 11610 was instated and is effective April 28, 2005. CAP
must abide by CLIA regulations and CLIA is part of the Center for Medicare
and Medicaid Services which is a section of the US government's department
of Health and Human Services. So if you would like to maintain your CLIA
license and CAP certification and be paid by Medicare you must abide by the
requirements for high complexity testing personnel for each person
performing any kind of gross examination. The actual wording is:
"Interpretive Guidelines §493.1489(b)(7)In the case of gross examinations,
the technical supervisor may delegate to individuals qualified under
§493.1489 the responsibility for the physical examination/description,
including color, weight, measurement and other characteristics of the
tissue; or other mechanical procedures for which a specific written protocol
has been developed. The technical supervisor is ultimately responsible for
the diagnosis related to the gross examination and must sign the examination
report. The technical supervisor is not required to provide direct onsite
supervision but is responsible for the accuracy of all test results
reported. All physical examinations/descriptions of tissue including color,
weight, measurement and other characteristics of the tissue; or other
mechanical procedures performed in the absence of the technical supervisor
by individuals qualified under §493.1489 should be reviewed within 24 hours
by the technical supervisor. All microscopic tissue examinations must be
performed by individuals qualified under §493.1449(b), (l) or (m), as


As I understand this, the technical supervisor (in this case the
dermatologist (or other physician) can or does take responsibility for
supervising grossing of small biopsies such as derm biopsies and can
delegate this to other personnel if supervised directly or indirectly within
24 hours.


My question is how is this being written up in procedure form so that it is
not rejected by the CLIA inspector. Does this interpretation require the
supervised technician doing the grossing to have 60 credits of education if
there is a detailed written guidelines for submitting the specimens in toto
as is done with dermatological specimens?


Thank you in advance for your help. 





Mickie Johnson, B.S., HTL(ASCP)

Mohs Histology Consulting Services, LLC

  & Mohs Lab Staffing

2507 S. Manito Blvd.

Spokane, WA 99203


FAX   509-624-3926

Web: www.mohshistogyconsulting.com & www.mohslabstaffing.com 

Email: mickie25@netzero.net



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