Re: [Histonet] CLIA REGS RE: Grossing: Chime In

From:"Roxanne Soto"

So in reading the link that you sent me including 493.1489, the person does not have to have a degree, as long as they have 60 credits including all of the sciences and 3 months of training?
  ----- Original Message ----- 
  From: Lance Erickson 
  To: Roxanne Soto ; Histonet@pathology.swmed.edu 
  Sent: Friday, March 03, 2006 4:10 PM
  Subject: RE: [Histonet] CLIA REGS RE: Grossing: Chime In


  www.cms.hhs.gov/clia is the link to the CLIA '88 information. See the new federal register CLIA intrepretive 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 appropriate."

  Lance Erickson
  Anatomic Pathology Supervisor
  Primary Children's Medical Center
  Salt Lake City, UT 

  -----Original Message-----
  From: histonet-bounces@lists.utsouthwestern.edu [mailto:histonet-bounces@lists.utsouthwestern.edu] On Behalf Of Roxanne Soto
  Sent: Friday, March 03, 2006 1:21 PM
  To: LuckG@empirehealth.org; Charles.Embrey@carle.com; Histonet@pathology.swmed.edu
  Subject: RE: [Histonet] CLIA REGS RE: Grossing: Chime In


     Greg,

     Thank  you  for your comment-that is exactly what I was trying to ask,
     but you put it so much better than I did.

     This  is what I need to know, as well, and I have had a very difficult
     time trying to find the answer by looking at the CLIA website.

     Roxanne
         ______________________________________________________________

       From:  "Luck, Greg D." >
       To:  "'Charles.Embrey'"                 >,
       Histonet@pathology.swmed.edu
       Subject:  [Histonet] CLIA REGS RE: Grossing: Chime In
       Date:  Fri, 3 Mar 2006 10:47:45 -0800
       >Charles,
       >In   answer   to   the   question  below  about  requirements  for
       "non-pathologists
       >grossing"  you  cited  the  specific text from CLIA '88 (493.1489)
       which states
       >the  requirements  for "analyzing patient samples" but I don't see
       how that
       >strictly  translates  to  "grossing" (in particular when we may be
       talking
       >about  the  simple  transfer  of  an  entire  specimen into tissue
       cassettes with a
       >visual  description  and  simple  specimen  prep  and set-up as in
       reducing the
       >sizes  of  the  sample  to  be  processed;  e.g.  bisection with a
       scalpel.
       >Wouldn't  simple  (where  the  entire specimen is submitted and no
       independent
       >decision  has  to  be  made  over what portions of the specimen to
       submit and/or
       >not  submit  for  micro  exam  by the pathologist be analogous for
       example to a
       >Micro  lab  aid  who  does this on tissue cultures.  "Grossing" by
       your comment
       >below   does   not   differentiate  between  shave  biopsy  and  a
       prostatectomy.
       >Where in CLIA does it's 'text' specifically state what constitutes
       >"grossing"  and  who  can  or can not perform CLIA's definition of
       grossing.
       >For  those  of  us less familiar with the federal register can you
       provide
       >me/us  with  the  specific text from the federal register that you
       cite in your
       >response  to the 2nd question of "does measuring cores and placing
       them in a
       >cassette  count  as  grossing?"  to  which  you  have  said yes it
       does.  Thanks,
       >Greg
       >Greg Luck, BS, HT(ASCP)
       >Anatomic Pathology Supervisor
       >Deaconess Medical Center
       >800 W. 5th Ave
       >Spokane, WA 99204
       >Phone 509.473.7077
       >Fax 509.473.7133
       >luckg@empirehealth.org
       >www.deaconessmedicalcenter.org
       >
       >
       >
       >
       >-----Original Message-----
       >From: Charles.Embrey [mailto:Charles.Embrey@carle.com]
       >Sent: Friday, March 03, 2006 7:10 AM
       >To: Histonet@pathology.swmed.edu
       >Subject: FW: [Histonet] CLIA REGS
       >
       >
       >
       >-----Original Message-----
       >From: Charles.Embrey
       >Sent: Friday, March 03, 2006 9:09 AM
       >To: 'Roxanne Soto'
       >Subject: RE: [Histonet] CLIA REGS
       >
       >CLIA  '88  lists  the  requirements for non-pathologists grossing.
       Grossing is
       >considered  high-complexity testing even if it's a punch biopsy or
       a shave.
       >
       >CLIA  '88  states "On or before April 24 1995 (I) be a high school
       graduate or
       >equivalent; and (b) have documentation of training appropriate for
       the test
       >performed before analyzing patient specimens"................After
       that date
       >it  requires  an  associate  degree  in  a  biological or chemical
       science or
       >medical   laboratory   technology   -or-   qualify  as  a  medical
       technologist with a
       >bachelor's  degree  from  an  accredited institution -or- earned a
       bachelor's
       >degree  in  a  chemical, physical, biologic or clinical laboratory
       science.
       >
       >ref. CLIA '88 493.1489
       >
       >As  to  your question: "Does measuring cores and putting them in a
       cassette
       >    Count  as grossing?" YES it does.  Whether a simple small skin
       tag or
       >dissection of an entire colon, the requirements are the same.
       >It   falls  under  the  CLIA  High  Complexity  Testing  Personnel
       Qualifications,
       >Federal Register VOl. 60, No. 78, April 1995, section
       >493.1489
       >
       >Also  CAP  requires a written instruction detailing what specimens
       may be
       >grossed  with direct vs indirect pathologists' observation. Direct
       means that
       >the  pathologist  literally  watches  over your shoulder while you
       gross the
       >specimen. Indirect means that he is readily available to consult.
       >
       >Now  as  far  a Florida is concerned:  Florida has one of the most
       stringent
       >licensing   systems   in   the   US.  I  fully  expect,  now  that
       Pathologists'
       >Assistants are a certified fact, that Florida will look closely at
       their
       >licensure and may limit grossing in the state to licensed P.A.s,
       >Pathologists  and residents.  At this point it is just a guess but
       I wouldn't
       >be surprised to see it happen in the not too distant future.
       >
       >Charles Embrey, PA(ASCP)
       >Carle Clinic
       >Urbana, IL
       >
       >
       >
       >
       >-----Original Message-----
       >From: histonet-bounces@lists.utsouthwestern.edu
       >[mailto:histonet-bounces@lists.utsouthwestern.edu]  On  Behalf  Of
       Roxanne Soto
       >Sent: Friday, March 03, 2006 6:39 AM
       >To: HISTONET@PATHOLOGY.SWMED.EDU
       >Subject: [Histonet] CLIA REGS
       >
       >
       >    Would  someone  from  CLIA  (or  someone  who  knows  the CLIA
       regs inside
       >    and  out)  please  contact  regarding  grossing  of
       tissue-----what is
       >    grossing  per  se--does  measuring cores and putting them in a
       cassette
       >    count  as  grossing?   What  education level doesn one have to
       have
       >in
       >    order to do this in the state of Florida?  We are in desperate
       need of
       >    lab  aides,  but  our  lab  aides  have  always had BS degrees
       and they
       >    "gross" out prostate cores.......
       >    Thanks in advance
       >    Roxanne Soto
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